Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Applicant
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
Product Code
PSZ · Microbiology
Decision Date
Sep 4, 2026
Decision
SESE
Submission Type
Dual Track
Regulation
21 CFR 866.3328
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2. The Sofia Strep A+ FIA detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for use as an aid in the diagnosis of Group A Streptococcal infection. The Sofia Strep A+ FIA may be used with Sofia or Sofia 2. The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay. The Sofia RSV FIA may be used with Sofia or Sofia 2.
Device Story
Sofia 2 is a microprocessor-controlled, desktop-sized (under 3 lbs) immunofluorescence analyzer; uses UV light (365 nm) to excite europium fluorophores on lateral flow test cassettes; camera captures emitted light (618 nm) from test strips; positive results determined by fluorescent signal intensity at test line exceeding specific cutoffs. Used in clinical settings by professional staff; provides rapid qualitative results to aid diagnosis. Software update (v2.0.14) modernizes drivers, migrates infrastructure from Python to C++, and refactors assay-specific algorithms into independent plugins; adds encryption for clinical data and enhanced user authentication. No hardware or cassette changes; intended use and clinical workflows remain identical to predicate.
Clinical Evidence
Bench testing only. No clinical studies performed. Analytical performance (LoD and near cut-off) compared software v1 and v2 using contrived samples (n=30-50 per analyte). Results showed 100% agreement between software versions for all analytes (Influenza A/B, RSV A/B, S. pyogenes) at tested concentrations.
Technological Characteristics
Microprocessor-controlled fluorometer; UV LED excitation (365 nm); camera-based detection (618 nm emission); lateral flow cassette interface. Software: Linux OS (Kernel 5.4), C++ programming, modular plugin architecture. Connectivity: USB export. Power: 100-240 VAC or rechargeable lithium polymer battery. Dimensions: 19.7 cm x 11.4 cm x 12.7 cm.
Indications for Use
Indicated for symptomatic patients requiring rapid differential diagnosis of influenza A/B, RSV (pediatric), or Group A Streptococcal pharyngitis. Contraindications: Not for influenza C detection; negative results are presumptive and require confirmation by culture or molecular assay.
Regulatory Classification
Identification
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
{0}
[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## DECISION SUMMARY
ASSAY AND INSTRUMENT
### I Background Information:
A 510(k) Number
K254262
B Applicant
Ortho Clinical Diagnostics, Inc. (QuidelOrtho)
C Proprietary and Established Names
Sofia Influenza A+B FIA
Sofia RSV FIA
Sofia Strep A+ FIA
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PSZ | Class II | 21 CFR 866.3328 Influenza virus antigen detection test system | Microbiology |
| GQG | Class I | 21 CFR 866.3480 Respiratory syncytial virus serological reagents | Microbiology |
| GTY | Class I | 21 CFR 866.3740 *Streptococcus spp.* serological reagents | Microbiology |
| KHO | Class I, exempt | 21 CFR 862.2560 - Fluorometer, For Clinical Use | Clinical Chemistry |
### II Submission/Device Overview:
A Purpose for Submission:
To obtain a substantial equivalence determination for the Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA assays as performed on the Sofia 2 analyzer using an updated software version (v.2.0.14).
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
# **B Measurand:**
# **Sofia Influenza A+B FIA:**
Influenza A and influenza B viral nucleoprotein antigens
# **Sofia RSV FIA:**
Respiratory syncytial virus (RSV) nucleoprotein antigen
# **Sofia Strep A+ FIA:**
Group A Streptococcal (GAS) antigens
# **C Type of Test:**
# **Sofia Influenza A+B FIA:**
Lateral flow fluorescent immunoassay (FIA)
# **Sofia RSV FIA:**
Lateral flow fluorescent immunoassay (FIA)
# **Sofia Strep A+ FIA:**
Lateral flow fluorescent immunoassay (FIA)
# **III Intended Use/Indications for Use:**
# **A Intended Use(s):**
See Indications for Use below.
# **B Indication(s) for Use:**
# **Sofia Influenza A+B FIA**
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions.
The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled “Update:
K254262- Page 2 of 16
{2}
Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples.
### **Sofia RSV FIA**
The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay.
The Sofia RSV FIA may be used with Sofia or Sofia 2.
### **Sofia Strep A+ FIA**
The Sofia Strep A+ FIA detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for use as an aid in the diagnosis of Group A Streptococcal infection.
The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.
### **C Special Conditions for Use Statement(s):**
For Prescription Use Only
### **D Special Instrument Requirements:**
Sofia 2 v. 2.0.14
## **IV Device/System Characteristics:**
### **A Device Description:**
#### **Sofia Influenza A+B FIA**
The Sofia Influenza A+B FIA is a rapid lateral flow immunoassay for the qualitative detection of influenza A and influenza B nucleoprotein in direct nasal swab (NS), nasopharyngeal swab (NP), and nasopharyngeal aspirate/wash (NA/W) specimens and NP and NA/W specimens in transport
K254262- Page 3 of 16
{3}
media collected from patients with signs and symptoms of respiratory infection. The Sofia Influenza A+B FIA components have not been modified; detailed description of the lateral flow device is available in K153012, K112177, and K162438 Decision Summaries describing the Sofia Influenza A+B FIA.
The Sofia 2 analyzer may be set to one of two operating modes: Walk Away or Read Now. Time to results for the Sofia 2 analyzer v. 2.0.14 are described below.
- Walk Away Mode: Sofia 2 analyzer scans the test cassette periodically during the test development time and displays a positive test result between 3 and 15 minutes. If the test is negative, the result will be displayed after 15 minutes. Failure to detect influenza A and B coinfection may occur when running the test on Sofia 2 analyzer in Walk Away mode.
- Read Now Mode: the user incubates the test cassette on the benchtop for 15 minutes before inserting the cassette into the Sofia 2 analyzer. Positive and negative test results are displayed within 1 minute. The Sofia 2 analyzer is able to report dual positive results (positive for Flu A and Flu B) in Read Now mode only.
Once testing is complete, Sofia 2 will display the test results (Influenza A Positive, Influenza B Positive Negative, Influenza A and B Positive or Invalid) on the screen. If an invalid test result is reported, the Sofia Influenza A+B FIA assay should be repeated with a new patient sample and a new test cassette. The fluorescence signal obtained with this assay is invisible to the unaided eye. The test results can only be obtained with the proper use of Sofia 2. Each Sofia Influenza A+B FIA kit will contain one Influenza A and Influenza B Positive and one Negative Control swab.
## Sofia RSV FIA
The Sofia RSV FIA is a rapid lateral flow immunoassay for the qualitative detection of RSV A and RSV B nucleoprotein from nasopharyngeal (NP) swab and nasopharyngeal aspirate/wash (NA/W) specimens collected from pediatric patients with signs and symptoms of respiratory infection. The Sofia RSV FIA components have not been modified; detailed description of the lateral flow device is available in K130398 and K162911 Decision Summaries.
Sofia 2 analyzer may be set to one of two operating modes: Walk Away or Read Now. Time to results for the Sofia 2 analyzer are described below.
- Walk away mode: Sofia 2 analyzer images the test cassette at 3, 5, 8, 10, and 15 minutes and reports a positive test result at the time RSV is detected. If the test is negative, the result will be displayed after 15 minutes.
- Read now mode: The user incubates the test cassette on the benchtop for 15 minutes before inserting the cassette into the Sofia 2 analyzer. Positive and negative test results are displayed within 1 minute.
Once testing is complete, Sofia 2 will display the test results (Positive, Negative, or Invalid) on the screen. If an invalid test result is reported, the Sofia RSV FIA assay should be repeated with a new patient sample and a new test cassette. The fluorescence signal obtained with this assay is invisible to the unaided eye. The test results can only be obtained with the proper use of Sofia 2. Each Sofia RSV FIA kit will contain one RSV Positive Control and one Negative Control swab.
K254262- Page 4 of 16
{4}
# Sofia Strep A+ FIA
The Sofia Strep A+ FIA is a rapid lateral flow immunoassay for the qualitative detection of Group A Streptococcal (GAS) antigens from throat swabs collected from patients with signs and symptoms of pharyngitis. The Sofia Strep A+ FIA components have not been modified; a detailed description of the lateral flow device is available in K141775 and K171976 Decision Summaries.
There are three possible test results for the Sofia Strep A+ FIA: Strep A positive, Strep A negative, and invalid. If an invalid test result is reported, the Sofia Strep A+ FIA should be repeated with a new patient sample and a new test cassette.
Sofia 2 analyzer may be set to one of two operating modes: Walk Away or Read Now. Time to results for the Sofia 2 analyzer are described below.
- Walk Away Mode: Sofia 2 analyzer automatically times the test development and provides positive or negative test results after 5 minutes.
- Read Now Mode: The user incubates the test cassette on the benchtop for 5 minutes before inserting the cassette into the analyzer. Positive and negative test results are displayed within 1 minute.
Once testing is complete, Sofia 2 will display the test results (Positive, Negative, or Invalid) on the screen. If an invalid test result is reported, the Sofia Strep A+ FIA assay should be repeated with a new patient sample and a new test cassette. The fluorescence signal obtained with this assay is invisible to the unaided eye. The test results can only be obtained with the proper use of Sofia 2. Each Sofia Strep A+ FIA kit will contain one Strep A Positive and one Negative Control swab.
## B Principle of Operation:
Sofia 2 family assays employ immunofluorescence-based lateral flow technology to perform qualitative detection of analytes in human clinical samples.
## C Instrument Description Information:
1. Instrument Name:
Sofia 2
2. Specimen Identification:
The Sofia 2 analyzer supports specimen identification through two methods: Barcode entry and manual entry.
3. Specimen Sampling and Handling:
The Sofia 2 analyzer supports multiple specimen types depending on the assay.
K254262- Page 5 of 16
{5}
Specimen collection is performed using the sterile swab or collection device provided or recommended in the test kit following the procedures specified in the assay-specific labeling.
# 4. Calibration:
The Sofia 2 analyzer uses an automated calibration system to ensure stable optical performance and minimize signal drift. A Calibration Check must be performed at least every 30 days, or as otherwise specified in the applicable assay labeling.
# 5. Quality Control:
The Sofia 2 analyzer uses Positive and Negative External Controls provided in each assay kit. External QC demonstrates that assay reagents, test cassettes, and procedures are functioning properly.
# V Substantial Equivalence Information:
# A Predicate Device Name(s):
Sofia Influenza A+B FIA
# B Predicate 510(k) Number(s):
K162438
# C Comparison with Predicates:
| Device & Predicate Device(s): | Proposed Device K254262 | | | Predicate Device K162438 |
| --- | --- | --- | --- | --- |
| Device Trade Name | Sofia Influenza A+B FIA | Sofia RSV FIA | Sofia Strep A+ FIA | Sofia Influenza A+B FIA |
| **General Device Characteristic Similarities** | | | | |
| Intended Use/Indications For Use | Same | See section III.B | See section III.B | The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is |
K254262- Page 6 of 16
{6}
| Device & Predicate Device(s): | Proposed Device K254262 | | | Predicate Device K162438 |
| --- | --- | --- | --- | --- |
| | | | | presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. This test is intended for professional and laboratory use. The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2. Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled “Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine.” Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples. |
| Analyzer | Sofia 2 | | | Same |
| Development Modes | Walk-Away and Read Now modes | | | Same |
K254262- Page 7 of 16
{7}
| Device & Predicate Device(s): | Proposed Device K254262 | Predicate Device K162438 |
| --- | --- | --- |
| Development time | Walk away mode: 3-15 minutes Read now mode: 1 minute | Same |
| Barcode Scanner (cassette) | Integrated barcode scanner | Same |
| Assay/instrument interface | Drawer (manual) | Same |
| User Interface | 4-inch color LCD touchscreen display | Same |
| User Types | Operator user, Supervisor, Service level | Same |
| **General Device Characteristic Differences** | | |
| Software version | v2.0.14 | v1.2.0 |
| Software | The software has been reengineered to enhance usability and to modernize the device drivers, without requiring any hardware modifications. | The firmware provides a Graphical User Inter-face and manages the workflow, algorithms, hardware integration (camera, sensors, screen, touch, power), and all interoperability functions. |
| Assay Framework | Existing assays were refactored to have algorithms, graphical user interface screens, and AMF components migrated into an assay-specific plugin that can be deployed independently of the firmware. Assay-related workflows (e.g., operator workflows and assay calculations) will no longer reside within the firmware. This architecture provides greater flexibility for allowing algorithms and user interface screens to be tailored to each individual assay. | Algorithms and screens reside in the firmware and are configured with an Assay Method File (AMF). Assay related workflows (such as operator workflows and assay calculations) reside inside of the firmware. |
| Assay Data Files | Assay plugin format | Assay Method File (AMF) |
| Operating System | Linux operating system Kernel version 5.4 | Linux operating system Kernel version 4.1 |
| Programming Language | C++ | Python |
| Security - Data Encryption | Encryption was added for database and clinical data | Database and clinical data not encrypted |
| Security - User Authentication | Enhanced support for unique and complex user identification and password | Combination user identification and password available |
| Security - Export Files | Encryption of export setting files to USB i.e., instrument settings | Export setting files to USB were not encrypted |
## VI Standards/Guidance Documents Referenced:
- Content of Premarket Submissions for Device Software Functions (June 14, 2023)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (February 2026)
- Bundling Multiple Devices or Multiple Indications in a Single Submission (June 22, 2007)
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
K254262- Page 8 of 16
{8}
For the purposes of the analytical and comparison studies, previous software versions of the Sofia 2 analyzer (v1.2.0) are collectively referred to as “software version 1” and the updated software version (v2.0.14) is referred to as “software version 2”.
1. Precision/Reproducibility:
The precision and reproducibility studies of the Sofia Influenza A+B FIA were previously assessed in K162438. Refer to K162438 Decision Summary for additional details.
The precision and reproducibility studies of the Sofia RSV FIA were previously assessed in K130398. Refer to K130398 Decision Summary for additional details.
The precision and reproducibility studies of the Sofia Strep A+ FIA were previously assessed in K171976. Refer to K171976 Decision Summary for additional details.
2. Linearity:
Not applicable
3. Analytical Specificity/Interference:
The analytical specificity/interference studies of the Sofia Influenza A+B FIA were previously assessed in K162438. Refer to K162438 Decision Summary for additional details.
The analytical specificity/interference studies of the Sofia RSV FIA were previously assessed in K130398. Refer to K130398 Decision Summary for additional details.
The analytical specificity/interference studies of the Sofia Strep A+ FIA were previously assessed in K171976. Refer to K171976 Decision Summary for additional details.
4. Detection Limit and Assay Reportable Range:
The purpose of these studies is to demonstrate that the Limit of Detection (LoD) is equivalent for Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA assays when run on the Sofia 2 analyzer using software version 2 and Sofia 2 software version 1. A calibration check of the Sofia 2 analyzers was performed prior to the beginning of the study. Positive and negative controls were tested on each analyzer prior to the testing. The control results were 100% as expected.
Sofia Influenza A+B FIA:
Contrived positive samples were prepared by spiking Influenza A/Victoria/2570/19 (Part no: 0810663CF) and Influenza B/Yamagata/Utah/09/14 (part no: 0810516CF) in negative nasal matrix (NNM), that was confirmed to be negative using a highly sensitive RT-PCR Influenza A+B Assay. 50 μL of sample was applied onto swabs for testing.
Ten (10) analyzers with software version 1 and ten (10) analyzers with software version 2 of the Sofia 2 and five (5) analyzers per influenza virus type were used in Read Now mode to
K254262- Page 9 of 16
{9}
test all replicates. In an initial range-finding study, a 1:5 dilution series was prepared and five replicates at each dilution were tested on one assay lot. The preliminary LoD was defined as the lowest concentration that all five replicates were detected and was determined to be 1.9 x10² TCID₅₀/mL for Influenza A/Victoria/2570/19 and 8.1 x10¹ TCID₅₀/mL for Influenza B/Yamagata/Utah/09/14, for both software versions. To confirm the LoD, replicates at 2-fold dilution level above and below the preliminary LoD were tested with twenty replicates each on one lot of the Sofia Influenza A+B FIA assay. The LoD was confirmed to be 1.9 x10² TCID₅₀/mL for Influenza A/Victoria/2570/19 and 1.6 x10² TCID₅₀/mL for Influenza B/Yamagata/Utah/09/14, for both software versions.
Table 1. Performance of the Sofia Influenza A+B FIA – Summary Results
| Influenza A | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Test Phase | Conc. (CFU/mL) | n | Sofia 2 Software Version 1 | | | Sofia 2 Software Version 2 | | |
| | | | Invalid | Neg. | Pos. (%) | Invalid | Neg. | Pos. (%) |
| Blank Negative | N/A | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Initial | 2.3E+04 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 4.7E+03 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 9.4E+02 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 1.9E+02 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 3.7E+01 | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Confirmation | 3.7E+02 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 1.9E+02 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 9.4E+01 | 20 | 0 | 16 | 4 (20) | 0 | 17 | 3 (15) |
| Influenza B | | | | | | | | |
| Test Phase | Conc. (CFU/mL) | n | Sofia 2 Software Version 1 | | | Sofia 2 Software Version 2 | | |
| | | | Invalid | Neg. | Pos. (%) | Invalid | Neg. | Pos. (%) |
| Blank Negative | N/A | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Initial | 2.5E+05 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 5.4E+04 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 1.0E+04 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 2.0E+03 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 4.0E+02 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 8.1E+01 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 1.6E+01 | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Confirmation | 3.2E+02 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 1.6E+02 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 8.1E+01 | 20 | 0 | 14 | 6 (30) | 0 | 16 | 4 (20) |
### Sofia RSV FIA:
Contrived positive samples were prepared by spiking RSV Type A (A2) and RSV Type B (18537 B-Washington) in negative nasopharyngeal matrix (NNPM). 50 μL of sample was applied onto swabs for testing.
Ten (10) analyzers with software version 1 and ten (10) analyzers with software version 2 of the Sofia 2, five (5) analyzers per RSV type, were used in Read Now mode to test all replicates. In an initial range-finding study, a 1:5 dilution series was prepared and five replicates at each dilution were tested on one assay lot. The preliminary LoD was defined as
K254262- Page 10 of 16
{10}
the lowest concentration that all five replicates were detected and was determined to be 5.0 x10⁴ TCID50/mL for RSV Type A (A2) and 2.7 x10⁴ TCID50/mL for RSV Type B (18537 B-Washington), for both software versions. To confirm the LoD, replicates at 2-fold dilution level above and below the preliminary LoD were tested with twenty replicates each on one lot of the Sofia RSV FIA assay. The LoD was confirmed to be 5.0 x10⁴ TCID₅₀/mL for RSV Type A (A2) and 2.7 x10⁴ TCID₅₀/mL for RSV Type B (18537 B-Washington), for both software versions.
Table 2. Performance of the Sofia RSV FIA – Summary Results
| RSV A | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Test Phase | Conc. (TCID50/mL) | n | Sofia 2 Software Version 1 | | | Sofia 2 Software Version 2 | | |
| | | | Invalid | Neg. | Pos. (%) | Invalid | Neg. | Pos. (%) |
| Blank Negative | N/A | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Initial | 1.3E+06 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 2.5E+05 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 5.0E+04 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 1.0E+04 | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| | 2.0E+03 | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Confirmation | 1.0E+05 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 5.0E+04 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 2.5E+04 | 20 | 0 | 20 | 0 (0) | 0 | 19 | 1 (5) |
| RSV B | | | | | | | | |
| Test Phase | Conc. (CFU/mL) | n | Sofia 2 Software Version 1 | | | Sofia 2 Software Version 2 | | |
| | | | Invalid | Neg. | Pos. (%) | Invalid | Neg. | Pos. (%) |
| Blank Negative | N/A | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Initial | 6.7E+05 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 1.3E+05 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 2.7E+04 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 5.4E+03 | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| | 1.1E+03 | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Confirmation | 5.4E+04 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 2.7E+04 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 1.3E+04 | 20 | 0 | 14 | 6 (30) | 0 | 13 | 7 (35) |
### Sofia Strep A+ FIA:
Contrived positive samples were prepared by spiking Streptococcus pyogenes (strain: Bruno) in negative oropharyngeal test matrix (NOTM) and applying 50 μL onto swabs for testing.
Five (5) analyzers software version 1 and five (5) analyzers with software version 2 of the Sofia 2 were used in Read Now mode to test all replicates. In an initial range-finding study, a 1:5 dilution series was prepared and five replicates at each dilution were tested on one assay lot. The preliminary LoD was defined as the lowest concentration that all five replicate were detected and was determined to be 2.3x10⁵ CFU/mL for both software versions. To confirm the LoD, replicates at 2-fold dilution level above and below the preliminary LoD were tested with twenty replicates each on one lot of the Sofia Strep A+ FIA assay. The LoD was confirmed to be 1.2x10⁵ CFU/mL for both software versions.
K254262- Page 11 of 16
{11}
Table 3. Performance of the Sofia Strep A+ FIA – Summary Results
| Test Phase | Conc. (CFU/mL) | n | Sofia 2 Software Version 1 | | | Sofia 2 Software Version 2 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Invalid | Neg. | Pos. (%) | Invalid | Neg. | Pos. (%) |
| Blank Negative | N/A | 5 | 0 | 5 | 0 (0) | 0 | 5 | 0 (0) |
| Initial | 1.2E+06 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 2.3E+05 | 5 | 0 | 0 | 5 (100) | 0 | 0 | 5 (100) |
| | 4.6E+04 | 5 | 0 | 5 | 0 (00) | 0 | 5 | 0 (00) |
| | 9.2E+03 | 5 | 0 | 5 | 0 (00) | 0 | 5 | 0 (00) |
| | 1.8E+03 | 5 | 0 | 5 | 0 (00) | 0 | 5 | 0 (00) |
| Confirmation | 2.3E+05 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 1.2E+05 | 20 | 0 | 0 | 20 (100) | 0 | 0 | 20 (100) |
| | 5.8E+04 | 20 | 0 | 20 | 0 (0) | 0 | 19 | 1 (5) |
The results of LoD equivalency studies for Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA, obtained using Sofia 2 analyzer with v1 and v.2, are acceptable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Not applicable
6. Assay Cut-Off:
Not applicable
### B Comparison Studies:
1. Method Comparison with Predicate Device:
The performance of the Sofia Influenza A+B FIA, Sofia RSV FIA, and Strep A+ FIA was evaluated by performing a method comparison study with the Sofia 2 analyzer with software version 1 and version 2. Contrived positive and negative samples were prepared in negative clinical matrix (see sections below). The test panel consisted of 30 negative samples and 50 positive samples. Positive samples were comprised of 18 low positive samples (1-3x LoD), 17 moderate positive samples (3-5x LoD), and 15 moderate to high positive samples (5-10x LoD) per analyte. Prior to testing, all samples were coded and randomized and confirmed on the Sofia 2 analyzer using software version 1. Testing was performed on ten (10) Sofia 2 analyzers (5 per software version) operating in Read Now mode using a single lot.
Specific sample preparation information and method comparison study results are presented for Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA below.
#### Sofia Influenza A+B FIA:
Contrived positive samples were prepared by spiking Influenza A/Victoria/2570/19 (Part no: 0810663CF) and Influenza B/Yamagata/Utah/09/14 (part no: 0810516CF) in NNM. Negative samples were NNM only. 50 \( \mu \) L of sample was applied onto swabs for testing.
K254262- Page 12 of 16
{12}
All positive and negative samples yielded 100% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for Influenza A/Victoria/2570/19 and Influenza B/Yamagata/Utah/09/14. Results demonstrated equivalent performance of Sofia Influenza A+B FIA using the Sofia 2 analyzer with both software versions for Influenza A/Victoria/2570/19 and Influenza B/Yamagata/Utah/09/14 strains.
### Sofia RSV FIA:
Contrived positive samples were prepared by spiking RSV Type A (A2) and RSV Type B (18537 B-Washington) in NNPM. Negative samples were NNPM only. 50 μL of sample was applied onto swabs for testing.
All negative and moderate and high positive samples yielded 100% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for RSV Type A (A2) and RSV Type B (18537 B-Washington). The low positive samples yielded 94% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for RSV Type A (A2) and yielded 100% for RSV Type B (18537 B-Washington). Results demonstrated equivalent performance of Sofia RSV FIA using the Sofia 2 analyzer with both software versions for RSV Type A (A2) and RSV Type B (18537 B-Washington) strains.
### Sofia Strep A+ FIA:
Contrived positive samples were prepared by spiking S. pyogenes (strain: Bruno) into NOTM. Negative samples were NOTM only. 50 μL of each sample was applied to swabs for testing.
All positive and negative samples yielded 100% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for S. pyogenes (strain: Bruno). Results demonstrated equivalent performance of Sofia Strep A+ FIA using the Sofia 2 analyzer with both software versions for S. pyogenes (strain: Bruno).
2. Matrix Comparison:
Not applicable
### C Clinical Studies:
1. Clinical Sensitivity:
Not applicable
2. Clinical Specificity:
Not applicable
K254262- Page 13 of 16
{13}
# 3. Clinical Cut-Off
Not applicable
# 4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
# **Performance Near Cut-Off**
To evaluate performance near the assay cut-off for the Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA, a panel of negative, low positive (1.5x LoD), and moderate positive (4x LoD) contrived samples were tested with the Sofia 2 analyzer software version 1 and version 2, in Read Now mode. Samples were tested in triplicate over five (5) days, two (2) runs per day, with at least two (2) operators, yielding 30 replicates per sample at a single site. Testing was performed on 20 analyzers (10 per software version) using one lot of each assay kit.
Specific sample preparation information and near cut-off performance results are presented for Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA below.
Sofia Influenza A+B FIA:
Contrived positive samples were prepared by spiking Influenza A/Victoria/2570/19 (Part no: 0810663CF) and Influenza B/Yamagata/Utah/09/14 (part no: 0810516CF) in NNM. Negative samples were NNM only. 50 μL of sample was applied onto swabs for testing.
Table 4. Sofia Influenza A+B FIA Near Cut-off Performance with Sofia 2 v1 and v2
| Sample | Concentration | Sofia 2 v1 | | Sofia 2 v2 | |
| --- | --- | --- | --- | --- | --- |
| | | % Agmt* (n/N) | 95% CI** | % Agmt (n/N) | 95% CI |
| Influenza A Victoria/2570/19 | Negative | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 1.5x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 4x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| Influenza B Yamagata/Utah/09/14 | Negative | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 1.5x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 4x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
*Agmt= Agreement, ** Confidence interval.
All positive and negative samples yielded 100% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for Influenza A Victoria/2570/19 and Influenza B Yamagata/Utah/09/14. Performance of the Sofia Influenza A+B FIA near the assay cut-off was equivalent between Sofia 2 analyzer software version 1 and version 2 for the influenza strains evaluated.
K254262- Page 14 of 16
{14}
### Sofia RSV FIA:
Contrived positive samples were prepared by spiking RSV Type A (A2) and RSV Type B (18537 B-Washington) in NNPM. Negative samples were NNPM only. 50 \( \mu \) L of sample was applied onto swabs for testing.
Table 5. Sofia RSV FIA Near Cut-off Performance with Sofia 2 v1 and v2
| Sample | Concentration | Sofia 2 v1 | | Sofia 2 v2 | |
| --- | --- | --- | --- | --- | --- |
| | | % Agmt* (n/N) | 95% CI** | % Agmt (n/N) | 95% CI |
| RSV Type A (A2) | Negative | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 1.5x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 4x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| RSV Type B (18537 B-Washington), | Negative | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 1.5x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 4x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
*Agmt= Agreement, ** Confidence interval.
All positive and negative samples yielded 100% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for RSV Type A (A2) and RSV Type B (18537 B-Washington). Performance of the Sofia RSV FIA near the assay cut-off was equivalent between Sofia 2 analyzer software version 1 and version 2 for the RSV strains evaluated.
### Sofia Strep A+ FIA:
Contrived positive samples were prepared by spiking S. pyogenes (strain: Bruno) into NOTM. Negative samples were NOTM only. 50 \( \mu \) L of each sample was applied to swabs for testing.
Table 6. Sofia Strep A+ FIA Near Cut-off Performance with Sofia 2 v1 and v2
| Sample | Concentration | Sofia 2 v1 | | Sofia 2 v2 | |
| --- | --- | --- | --- | --- | --- |
| | | % Agmt* (n/N) | 95% CI** | % Agmt (n/N) | 95% CI |
| S. pyogenes | Negative | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 1.5x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
| | 4x LoD | 100.0% (30/30) | 88.6 – 100.0% | 100.0% (30/30) | 88.6 – 100.0% |
*Agmt= Agreement, ** Confidence interval.
K254262- Page 15 of 16
{15}
All positive and negative samples yielded 100% agreement with the expected result with the Sofia 2 analyzer software version 1 and version 2 for S. pyogenes. Performance of the Sofia Strep A+ FIA near the assay cut-off was equivalent between Sofia 2 analyzer software version 1 and version 2 for the S. pyogenes evaluated.
# **D Expected Values/Reference Range:**
# **Sofia Influenza A+B FIA:**
A patient sample is expected to be negative for Influenza A and B.
# **Sofia RSV FIA:**
A patient sample is expected to be negative for RSV.
# **Sofia Strep A+ FIA:**
A patient sample is expected to be negative for Strep A.
# **E Other Supportive Instrument Performance Characteristics Data:**
1) Electromagnetic compatibility
Electrical safety and electromagnetic compatibility (EMC) testing were performed, and the new test system was found to be acceptable.
2) Software and cybersecurity
Software and cybersecurity documentation was reviewed and found to be acceptable.
# **VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
# **IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K254262- Page 16 of 16
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Guidance alerts
New and changed FDA guidance documents, emailed as a daily digest.
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the ? button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only Software as a Medical Device, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (Software as a Medical Device), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
