The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
Device Story
Sample Preservative Fluid is a liquid medium for stabilization and inactivation of Influenza A virus in upper respiratory specimens. Input: unprocessed upper respiratory specimens collected via nasopharyngeal swab. Operation: fluid contains Triton X-100 and guanidine thiocyanate to denature viral proteins/nucleases, inactivating the virus while preserving RNA. Output: stabilized viral RNA in a screw-cap tube for downstream molecular diagnostic testing. Used in clinical or laboratory settings; operated by healthcare professionals. Benefits: enables safe transport and storage of infectious samples at room temperature (20-25°C) or refrigerated (2-8°C) for up to 35 days, facilitating accurate molecular detection.
Clinical Evidence
No clinical data. Bench testing only. Analytical performance included a limit of detection (LoD) study using the Cepheid Xpert Xpress Flu/RSV Assay, establishing an LoD of 0.08 TCID50/mL for Influenza A H3N2. Stability studies confirmed Influenza A RNA integrity in the fluid for 35 days at 2-4°C and 20-25°C. Viral inactivation studies demonstrated a >4.7 log reduction (>99.99%) in Influenza A H3N2 titer after 30 and 60 seconds of exposure.
Technological Characteristics
Composition: guanidine thiocyanate, Triton X-100, nuclease-free water. Form factor: screw-cap tube with 2 mL fluid and nasopharyngeal swab. Single-use. Non-sterile. No electronic components or software.
Indications for Use
Indicated for stabilization, transport, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Suitable for use with compatible molecular diagnostic devices.
Regulatory Classification
Identification
A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.
Special Controls
The special controls for this device are: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of microorganisms and types of human specimens intended to be preserved. (2) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including all device components. (ii) Performance characteristics from applicable analytical studies, including but not limited to, nucleic acid stability and microorganism inactivation. (iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing. (iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies. (3) Design verification and validation must include the following: (i) Overall device design including all device components and all control elements incorporated into the analytical validation procedures. (ii) Thorough description of the microorganisms and methodology used in the validation of the device including, but not limited to, extraction platforms and assays used for the detection of preserved nucleic acids. (iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K222771
B Applicant
Hangzhou Bioer Technology Co., Ltd
C Proprietary and Established Names
Sample Preservative Fluid
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBD | Class II | 21 CFR 866.2950 - Microbial Nucleic Acid Storage And Stabilization Device | MI - Microbiology |
## II Submission/Device Overview:
A Purpose for Submission:
To obtain a substantial equivalence determination for Hangzhou Bioer Technology Co., Ltd Sample Preservative Fluid for the collection, transport, and storage of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A for downstream testing with nucleic acid-based assay.
B Measurand:
Storage and stability of nucleic acids from Influenza A virus
C Type of Test:
Microbial nucleic acid storage and stabilization device
## III Intended Use/Indications for Use:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K222771 - Page 2 of 9
A Intended Use(s):
Refer to Indications for Use below.
B Indication(s) for Use:
The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Not applicable
IV Device/System Characteristics:
A Device Description:
Sample Preservative Fluid is a medium for stabilization of Influenza A RNA during sample transport/storage. The fluid is composed of guanidine thiocyanate, Triton X-100, and nuclease-free water. Sample Preservative Fluid is provided in a labeled screw-cap tube.
Sample Preservative Fluid configuration:
- BSC82X1-A1: a screw-cap tube filled with 2 ml of Sample Preservative Fluid liquid and a prepackaged nasopharyngeal swab for sample collection
- Nasopharyngeal swab: regular size, sterile disposable sample swab (80mm breakpoint)
B Principle of Operation:
Sample Preservative Fluid consists of detergent Triton X-100 and denaturant. The denaturant and detergent denature and/or separate the proteins and nucleases of the virus, then inactivate the virus. The nucleic acid is isolated and preserved in the liquid and can be stored or transported for testing at a laboratory.
V Substantial Equivalence Information:
A Predicate Device Name(s):
PrimeStore MTM
B Predicate 510(k) Number(s):
DEN170029
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C Comparison with Predicate(s):
| | Device: K222771 | Predicate: DEN170029 |
| --- | --- | --- |
| Device Trade Name | Sample Preservative Fluid | PrimeStore MTM |
| General Device Characteristic Similarities | | |
| Intended Use / Indications For Use | The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices. | PrimeStore MTM is intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples. |
| Specimen storage temperature | 2-25°C | 2-25°C |
| Shelf-life | 24 months | 24 months |
| General Device Characteristic Differences | | |
| Microorganism nucleic acids preserved | Influenza A virus | Influenza A virus and Mycobacterium tuberculosis |
| Specimen type | Upper respiratory specimens | Nasal washes and sputum samples |
| Analyte | RNA | DNA, RNA |
| Specimen stability | 2-25°C ≤ 35 days | For Influenza A virus: 4°C ≤ 29 days 27°C ≤ 8 days |
VI Standards/Guidance Documents Referenced:
Special controls that are applicable to regulation 21 CFR 866.2950
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility: Not applicable
2. Linearity: Not applicable
K222771 - Page 3 of 9
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3. Analytical Specificity/Interference:
Not applicable
4. Assay Reportable Range:
Not applicable
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
**Shelf Life:**
Three lots of Sample Preservative Fluid stored at 2-8°C and 25°C were assessed at 10 timepoints (0, 3, 6, 12, 13, 15, 18, 21, and 24 months). At each timepoint, each kit was evaluated for bacterial or fungal growth, changes in appearance, the tightness of the cap to ensure no leakage, and density of the liquid.
The study acceptance criteria included the following: there should be no bacterial or fungal growth, no obvious change in appearance, there should be no tube leakage at -0.08 MPa for ten minutes, and the media density should remain 1.06 ± 0.04 g/mL.
All three lots stored at 2-8°C and 25°C met physical and chemical property evaluation acceptance criteria for all timepoints. There was no bacterial or fungal growth, change in appearance, no leakage, and no change in density over time. The shelf-life of the reagent when stored at 2-25°C is 24 months.
The Sample Preservative Fluid is not claimed to be sterile nor is it intended to be sterilized by the end user. These vials are single-use devices. The products are packaged in sterile PE bags to ensure the media is not contaminated during shipping.
6. Detection Limit:
Limit of detection (LoD) testing was conducted to evaluate the lowest concentration of analyte that can be detected at greater than or equal to 95% detection rate.
**Preliminary Limit of Detection (LoD) Study:**
The cleared assay used for the LoD study when testing samples collected in the subject device was the Cepheid Xpert Xpress Flu/RSV Assay (K180218). The LoD of the Xpert Xpress Flu/RSV Assay for Influenza A H3N2 is:
- Influenza A/Perth/16/2009: 0.01 TCID₅₀/mL
- Influenza A/Victoria/361/2011: 0.75 TCID₅₀/mL
Because the two viral strains used in the Cepheid LoD study were no longer available, another Influenza A H3N2 strain, A/California/2/2014 VR-1938, was used.
Influenza A H3N2 (A/California/2/2014, VR-1938) was diluted with negative nasal matrix to 0.32 TCID₅₀/mL. Serial two-fold dilutions were performed to create samples at 0.16, 0.08, 0.04, 0.02 and 0.01 TCID₅₀/mL. Five replicates of each sample were tested for Influenza A with the Xpert Express Flu/RSV Assay. The lowest concentration that yielded a greater than or equal to 80% detection rate was further tested to confirm LoD, table 1 below.
K222771 - Page 4 of 9
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Table 1. Preliminary LoD test results:
| Influenza A Concentration (TCID50/mL) | Rep 1 (Ct) | Rep 2 (Ct) | Rep 3 (Ct) | Rep 4 (Ct) | Rep 5 (Ct) | Avg (Ct) | SD (Ct) | CV (%) | Detection Rate (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 0.32 | 33.4 | 33.1 | 34.2 | 33.2 | 33.4 | 33.5 | 0.39 | 1.16% | 100% |
| 0.16 | 34.3 | 34.5 | 36.9 | 34.2 | 34.3 | 34.8 | 1.03 | 2.97% | 100% |
| 0.08 | 35.0 | 36.1 | 35.3 | 35.2 | 34.5 | 35.2 | 0.519 | 1.47% | 100% |
| 0.04 | 37.3 | 36.2 | 39.2 | 36.8 | No Ct | 37.4 | 1.12 | 3.01% | 80% |
| 0.02 | 38.5 | 38.7 | 38.3 | No Ct | No Ct | 38.5 | 0.163 | 0.424% | 60% |
| 0.01 | 37.9 | 37.3 | No Ct | No Ct | No Ct | 37.6 | 0.300 | 0.798% | 40% |
# Confirmatory Limit of Detection (LoD):
To confirm LoD, additional testing of 20 replicates at $0.04\mathrm{TCID}_{50} / \mathrm{mL}$ was performed. When testing of 8 replicates at $0.04\mathrm{TCID}_{50} / \mathrm{mL}$ yielded $>2$ negative results, testing was terminated, and a retest was performed at $0.08\mathrm{TCID}_{50} / \mathrm{mL}$ . $100\%$ of replicates at $0.08\mathrm{TCID}_{50} / \mathrm{mL}$ were positive confirming the assay LoD as $0.08\mathrm{TCID}_{50} / \mathrm{mL}$ , table 2 below.
Table 2. Confirmatory LoD test results:
| Replicate | 0.08 TCID50/mL Influenza A (Ct) |
| --- | --- |
| 1 | 34.5 |
| 2 | 35.2 |
| 3 | 36.2 |
| 4 | 35.2 |
| 5 | 35.0 |
| 6 | 35.1 |
| 7 | 36.5 |
| 8 | 35.4 |
| 9 | 35.6 |
| 10 | 35.1 |
| 11 | 35.2 |
| 12 | 35.8 |
| 13 | 34.8 |
| 14 | 35.2 |
| 15 | 35.3 |
| 16 | 36.4 |
| 17 | 35.1 |
| 18 | 35.2 |
| 19 | 35.6 |
| 20 | 34.7 |
| Average | 35.4 |
| SD | 0.517 |
| CV (%) | 1.46% |
| Detection Rate (%) | 100% |
# 7. Specimen Stability:
A specimen stability study was conducted to evaluate the stability of Influenza A virus RNA spiked into negative matrix and stored in Sample Preservative Fluid at both a refrigerated temperature $(2 - 4^{\circ}\mathrm{C})$ and at room temperature $(20 - 25^{\circ}\mathrm{C})$ for 35 days. Influenza A H3N2
K222771 - Page 5 of 9
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(A/California/2/2014, VR-1938) was diluted to 3x the LoD (0.24 TCID $_{50}$ /mL) with negative nasal matrix collected with three reagent lots. Samples collected with each of the three lots were tested in replicates of four with the Xpert Xpress Flu/RSV Assay on Day 0. Samples were stored at refrigerated (2-4°C, table 3 below) and room temperature (20-25°C, table 4 below) and tested in replicates of four on Days 1, 8, 15, 22, and 35.
Table 3. Influenza A stability ${2 - 4}^{ \circ }\mathrm{C}$ :
| Specimens | Lot | Rep | Day0 (Ct) | Day1 (Ct) | Day8 (Ct) | Day15 (Ct) | Day22 (Ct) | Day35 (Ct) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 0.24 TCID50/mL Influenza A in nasal matrix | 1 | 1 | 33.5 | 33.1 | 33.4 | 33.9 | 33.6 | 35.6 |
| | | 2 | 33.5 | 34.0 | 33.7 | 34.0 | 33.9 | 34.3 |
| | | 3 | 33.0 | 33.4 | 33.4 | 33.5 | 34.3 | 33.9 |
| | | 4 | 33.4 | 34.8 | 33.9 | 33.3 | 33.9 | 34.0 |
| | 2 | 1 | 33.4 | 33.2 | 33.5 | 33.8 | 33.5 | 34.3 |
| | | 2 | 34.0 | 33.4 | 33.4 | 33.9 | 34.0 | 34.4 |
| | | 3 | 33.5 | 33.5 | 33.9 | 33.7 | 33.5 | 34.1 |
| | | 4 | 33.9 | 33.3 | 33.8 | 33.5 | 34.0 | 33.7 |
| | 3 | 1 | 33.7 | 33.6 | 33.8 | 33.5 | 33.8 | 34.2 |
| | | 2 | 33.7 | 33.3 | 33.7 | 33.6 | 33.8 | 33.7 |
| | | 3 | 33.5 | 33.2 | 34.0 | 33.6 | 33.7 | 34.2 |
| | | 4 | 33.3 | 33.5 | 33.7 | 33.7 | 33.7 | 34.4 |
| | Average | | 33.5 | 33.5 | 33.7 | 33.7 | 33.8 | 34.2 |
| | SD | | 0.256 | 0.446 | 0.203 | 0.197 | 0.222 | 0.473 |
| | CV (%) | | 0.764% | 1.33% | 0.604% | 0.586% | 0.655% | 1.38% |
Table 4. Influenza A stability ${20} - {25}^{ \circ }\mathrm{C}$ :
| Specimens | Lot | Rep | Day0 (Ct) | Day1 (Ct) | Day8 (Ct) | Day15 (Ct) | Day22 (Ct) | Day35 (Ct) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 0.24 TCID50/mL Influenza A in nasal matrix | 1 | 1 | 34.0 | 34.1 | 34.3 | 33.6 | 33.4 | 33.9 |
| | | 2 | 34.0 | 33.9 | 33.3 | 33.9 | 33.9 | 34.7 |
| | | 3 | 33.7 | 33.3 | 34.0 | 33.9 | 33.9 | 34.1 |
| | | 4 | 33.5 | 33.9 | 34.3 | 34.2 | 33.7 | 34.4 |
| | 2 | 1 | 33.8 | 33.3 | 33.6 | 33.5 | 33.6 | 34.0 |
| | | 2 | 33.9 | 33.2 | 33.4 | 34.0 | 34.0 | 33.4 |
| | | 3 | 33.4 | 33.4 | 34.5 | 33.4 | 33.9 | 33.7 |
| | | 4 | 33.7 | 33.5 | 33.4 | 33.6 | 33.4 | 34.1 |
| | 3 | 1 | 34.0 | 33.4 | 33.6 | 33.3 | 33.7 | 34.1 |
| | | 2 | 33.5 | 33.0 | 33.7 | 34.3 | 34.0 | 35.2 |
| | | 3 | 34.0 | 33.5 | 33.8 | 34.2 | 33.6 | 34.2 |
| | | 4 | 34.3 | 33.1 | 33.6 | 34.1 | 33.7 | 34.0 |
| | Average | | 33.8 | 33.5 | 33.8 | 33.8 | 33.7 | 34.2 |
| | SD | | 0.254 | 0.325 | 0.379 | 0.180 | 0.201 | 0.443 |
| | CV (%) | | 0.752% | 0.971% | 1.12% | 0.534% | 0.597% | 1.30% |
K222771 - Page 6 of 9
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At each timepoint, Influenza A spiked into nasal matrix and preserved at refrigerated temperature (2-4°C) or room temperature (20-25°C) yielded positive results, which showed the Influenza A H3N2 nucleic acid was detected.
All the Ct values fell within a 3.0 Ct range of results from the Ct values generated for time point zero, which met the pre-defined acceptance criteria. The Influenza A H3N2 virus nucleic acid was preserved in the Sample Preservative Fluid without degradation at refrigeration (2-4°C) and room (20-25°C) temperatures for 35 days.
8. Viral Inactivation Study:
An inactivation study was performed to determine the rate the Sample Preservative Fluid inactivates Influenza A.
Cytotoxicity Study:
A cytotoxicity study was performed to determine at what dilution ratio the Sample Preservative Fluid would not be toxic to a cell monolayer.
A preliminary test was performed by diluting the Sample Preservative Fluid with complete cell culture medium at multiple dilutions (from 1:10 up to 1:8000) and adding it to a monolayer of cells. When the Sample Preservative Fluid dilution ratio exceeded 1:4000 both the test group and the control group showed normal cell morphology and growth, demonstrating that there was no significant cytotoxicity for the Sample Preservative Fluid with high dilution ratios.
A confirmatory test was performed by diluting the Sample Preservative Fluid with complete cell culture medium at multiple dilution (from 1:1000 to 1:10000) and adding it to a monolayer of cells. When the dilution ratio reached or exceeded 1:3500, both the test group and the control group showed normal cell morphology and growth status, and no significant difference between the test group and the control group were observed.
Conclusion: When the dilution ratio reached or exceeded 1:3500, both the test group and the control group showed normal cell morphology and growth status, and no significant difference between the test group and the control group were observed. There was no toxicity to the MDCK cell monolayer when the Sample Preservative Fluid was diluted to equal to or greater than 3500 times.
Inactivation Study:
To evaluate successful inactivation of Influenza A virus, Influenza A H3N2 virus was combined at a ratio of 1:1 with negative nasal matrix mixed with Sample Preservative Fluid and incubated for 30 and 60 seconds. The initial concentration of the Influenza A H3N2 was >1×10⁷ TCID₅₀/mL. Each mixture was then diluted 3500× (as determined in the cytotoxicity study) with complete cell culture medium. Each dilution was plated into 8 wells of a 96-well cell culture plate in triplicate and incubated for 3-4 hours. The medium was removed and replaced with 100μL of complete cell culture medium. The plate was incubated at 34°C and 5% CO₂ atmosphere for 4-7 days. The plate was observed for cytopathic effects and virus titers were calculated.
Additionally, positive controls containing Influenza A H3N2 virus and sterile saline were mixed at a ratio of 1:1 and incubated for 30 and 60 seconds. Each mixture was then diluted to
K222771 - Page 7 of 9
{7}
3500x (as determined in the cytotoxicity study) with complete cell culture medium. Each dilution was plated into 8 wells of a 96-well cell culture plate in triplicate and incubated for 3-4 hours. The medium was removed and replaced with 100μL of complete cell culture medium. The plate was incubated at 34°C and 5% CO₂ atmosphere for 4-7 days. The plate was observed for cytopathic effects and virus titers were calculated.
Negative controls were also evaluated as part of this study in which MDCK cells were incubated with complete cell culture medium 34°C and 5% CO₂ atmosphere for 4-7 days. The plate was observed for cell growth and culture contamination.
No cytotoxicity was observed in the cell monolayer after exposure to Influenza A virus samples incubated in Sample Preservative Fluid for 30 or 60 seconds. The result was a greater than a ≥4.7 logarithmic reduction in Influenza A after a 30 and 60 seconds in the Sample Preservative Fluid. Therefore, the Sample Preservative Fluid Inactivated Influenza A H3N2 in MDCK cells and the device demonstrated a viral inactivation ration of >99.99%. Cytotoxicity was observed in the positive control group, and no viral infection was observed in the negative control group.
9. Assay Cut-Off: Not applicable
B Comparison Studies:
1. Method Comparison with Predicate Device: Not applicable
2. Matrix Comparison: Not applicable
C Clinical Studies:
1. Clinical Sensitivity: Not applicable
2. Clinical Specificity: Not applicable
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable
D Clinical Cut-Off: Not applicable
E Expected Values/Reference Range: Not applicable
VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device.
K222771 - Page 8 of 9
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IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K222771 - Page 9 of 9
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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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.
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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.
