Retrospective clinical data and frozen clinical specimens were used to evaluate the performance (sensitivity and agreement) of the FLU OIA A/B assay compared to cell culture and the predicate device.
Retrospective analysis of previously collected clinical data; Retrospective analysis
184 patients; Sample Size: 184; Number of Sites: Multi-center
Cell culture with fluorescent antibody staining
Sensitivity to Influenza A and B
Retrospective frozen clinical specimens comparison; Retrospective comparative study
Clinical specimens; Sample Size: 112
Original FLU OIA assay (K981651)
Agreement
Indications for Use
The Thermo BioStar™ FLU OIA* A/B assay is an Optical ImmunoAssay test for the qualitative, rapid detection of influenza A and B viral antigens (nucleoproteins) extracted from nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. This test is intended for in vitro diagnostic use to aid in the differential diagnosis of influenza A and B viral infections. The FLU OIA A/B test is not intended for detection of influenza C. Negative test results should be confirmed by cell culture.
Device Story
FLU OIA A/B is a rapid, qualitative in vitro diagnostic test for influenza A and B viral antigens. Input: nasal aspirate, nasopharyngeal swab, throat swab, or sputum specimens. Principle: Optical ImmunoAssay technology using a silicon wafer surface. Immobilized antibodies capture viral nucleoproteins; substrate addition increases molecular thin film thickness (mass enhancement). This physical change alters the reflected light path, producing a visible color change (purple spot on gold background). Used in clinical or point-of-care settings by healthcare personnel. Output: visual colorimetric result. Assists clinicians in differential diagnosis of influenza A and B infections. Benefits patient through rapid identification of viral type, facilitating timely clinical management.
Clinical Evidence
Retrospective analysis of 184 patients compared FLU OIA A/B to cell culture with fluorescent antibody staining. 151 specimens were culture-positive (129 Influenza A, 22 Influenza B). Sensitivity for Influenza A was 82.9% (95% CI: 75.3-89.0%); sensitivity for Influenza B was 63.6% (95% CI: 40.7-82.8%). Agreement with the original FLU OIA assay on 112 retrospective specimens was 100% (95% CI: 96.8-100%). Reproducibility study across four sites showed 96.6% overall agreement.
Technological Characteristics
Optical ImmunoAssay technology utilizing silicon wafer surfaces. Qualitative visual detection based on mass enhancement of molecular thin films. No electronic components, software, or external energy sources required. Manual test procedure.
Indications for Use
Indicated for qualitative, rapid detection of influenza A and B viral nucleoproteins in nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. Aids in differential diagnosis of influenza A and B infections. Not for influenza C detection. Negative results require cell culture confirmation.
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.
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#### 510(k) SUMMARY (page 1 of 3) 8.0
# 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K023556
A. Safety and effectiveness information required per [§807.92(a)(1)]:
- . SUBMITTER'S NAME: Thermo BioStar, Inc.
- ADDRESS: 331 South 104th Street .
- TELEPHONE: (303) 530-3888 ext. 612 .
- . FAX: (303) 581-6405
- CONTACT PERSON: John G. Adams ●
- DATE 510(k) SUMMARY PREPARED: October, 2002; revised March, 2003 .
B. Safety and effectiveness information required per [§807.92(a)(2)]:
- TRADE OR PROPRIETARY NAME: FLU OIA® A/B .
- . COMMON NAME: Influenza Rapid Assay
- CLASSIFICATION NAME: Antigen, CF (including CF Controls), Influenza Virus A, B, C
C. Identification of legally marketed device to which we are comparing performance.
Device Technology:
| Trade or Proprietary Name: | AB FLU OIA test kit |
|----------------------------|---------------------|
| Regulatory Class: | I |
| Manufacturer: | Thermo BioStar |
| 510(k) Number: | K981651 |
Historical Reference Method:
Viral Culture
Intended use of device { \$807.92(a)(5)]:
The Thermo BioStar" FLU OIA* A/B assay is an Optical ImmunoAssay test for the qualitative, rapid detection of influenza A and B viral antigens (nucleoproteins) extracted from nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. This test is intended for in vitro diagnostic use to aid in the differential diagnosis of influenza A and B viral infections. The FLU OIA A/B test is not intended for detection of influenza C. Negative test results should be confirmed by cell culture.
- D. Description of device [§807.92(a)(4)]:
Principle of the Test:
The FLU OIA A/B test involves the extraction and detection of a protein antigen unique to influenza A or B (nucleoprotein). The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the
{1}------------------------------------------------
#### 8.0 510(k) SUMMARY (page 2 of 3)
immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.
### DEVICE COMPARISON:
### Device Technology:
The FLU OIA A/B assay addressed in this submission is identical to the FLU OIA assay previously cleared in that:
- Both assays are rapid diagnostic tests that utilize Optical ImmunoAssay technology ●
- Both assays are used to detect and identify antigen proteins specific to influenza B . infections.
- . Both assays can provide results in less than 20 minutes.
- . Both assays are qualitative.
- Neither assay is intended to detect influenza C . .
The FLU OIA A/B assay differs from the currently marketed FLU OIA assay in that:
- The original FLU OIA assay (K981651) does not differentiate A from B influenza antigens. FLU OIA . A/B allows for the independent identification of viral type B antigens from the same specimen.
### SUMMARY OF PERFORMANCE DATA:
### ANALYTICAL and CLINICAL Comparison
Performance characteristics for the original AB FLU OIA assay were initially established in a multi-center study with geographically diverse clinical sites. The analytical sensitivity of the FLU OIA A/B test is equivalent to that of the FLU OIA test, as measured by comparability studies carried out using inactivated virus standards, live virus strains, and a panel of retrospective frozen clinical specimens.
- H. Summary of testing [§807.92(b)(2)]:
#### Reproducibility
#### Inter-Laboratory
Representatives of three POL or clinic sites, and one internal Thermo BioStar site conducted reproducibility testing. Individual panels were prepared , each containing nine blinded specimens and two controls. Each panel was performed on three different occasions, by personnel from the four different laboratories. The samples consisted of throat swabs spiked with negative, low positive, moderate positive, and high positive specimens for each virus type. These samples were spiked onto swabs for analysis.
Overall reproducibility for the sample panel was 96.6% across all sites (255/264).
#### Intra-Laboratory
Reproducibility of the assay was evaluated by testing specimens at or near the cut-off in multiple replications (n=20). The cut-off was defined as the level of virus at which it would be expected that the assay would be positive 50% of the time and negative 50% of the time.
8.0
{2}------------------------------------------------
#### 8.0 510(k) SUMMARY (page 3 of 3)
#### Clinical Sample Comparison
A retrospective analysis was conducted of previously collected clinical data comparing the FLU OIA test to commercially available cell culture, with confirmation and typing by fluorescent antibody staining. A total of 184 patients were enrolled into the multi-center study. Data available for analysis included 151 specimens that were positive by culture. Of the 151, 129 were confirmed as Influenza A and 22 were confirmed as Influenza B. Sensitivity to Influenza A is calculated as 82.9% (95%C.I. = 75.3-89.0), and sensitivity to Influenza B is calculated as 63.6% (95% C.I.= 40.7-82.8%)
The performance of the FLU OIA A/B assay was also compared to the original FLU OIA assay on 112 retrospective frozen clinical specimens. For positive specimens (4) agreement was 100% (95% Cl = 39.8 -100). Overall agreement was 100% (95% CI = 96.8 - 100)
#### I. Conclusions from nonclinical / clinical testing [§807.92(b)(3)]:
Analytical testing was performed on both microbial and viral panels to assess specificity and cross reactivity.
Whole blood and several types of over the counter (OTC) products were evaluated to assess the potential for interference.
The results of the above described internal and external studies demonstrated that the FLU OIA A/B is safe and effective .
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 7 2003
Mr. John G. Adams Regulatory Affairs Thermo BioStar 331 South 104th Street Louisville, CO 80027
Re: k023556
> Trade/Device Name: FLU OIA ® A/B Test Kit Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: January 25, 2003 Received: January 28, 2003
Dear Mr. Adams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
## Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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#### INDICATIONS FOR USE STATEMENT 12.0
#### INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K023556
FLU OIA® A/B Device Name:
Indications For Use:
The Thermo BioStar™ FLU OIA* A/B assay is an Optical ImmunoAssay test for the qualitative, rapid detection of influenza A and B viral antigens (nucleoproteins) extracted from nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. This test is intended for in vitro diagnostic use to aid in the differential diagnosis of influenza A and B viral infections. The FLU OIA A/B test is not intended for detection of influenza C. Negative test results should be confirmed by cell culture.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Sledditu Poole
Over-The-Counter Use
(Optional Format 1-2-96)
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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 Tutorial 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-only devices, 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-only devices), 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.
