(26 days)
The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
The OSOM® Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to Influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.
The provided text describes an update to the package insert of the OSOM® Influenza A&B Test (K092633) to include additional analytical reactivity information for specific H3N2v Influenza A strains. It is not an original submission for a new device, but rather a modification to an already cleared device. As such, the information typically found in an initial 510(k) for device performance and clinical studies demonstrating efficacy for establishing acceptance criteria and proving they are met is largely absent in this document.
However, based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here is the ability of the OSOM® Influenza A&B Test to react with and detect specific influenza A strains. The stated performance is that the device does react with these strains.
| Acceptance Criteria (Ability to Detect) | Reported Device Performance |
|---|---|
| A/WEST VIRGINIA/06/2011 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+05 EID50/mL*) |
| A/PENNSYLVANIA/14/2010 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+08 EID50/mL*) |
| A/MINNESOTA/11/2010 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+08 EID50/mL*) |
| A/KANSAS/13/2009 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+05 EID50/mL*) |
| A/INDIANA/08/2011 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+06 EID50/mL*) |
| A/INDIANA/10/2011 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.00E+09 EID50/mL*) |
Note: The document specifies that "the performance characteristics of this device with clinical specimens that are positive for these 2009 H1N1 and H3N2v influenza viruses have not been established." This indicates these results are from analytical reactivity studies, not clinical performance studies.
2. Sample Size Used for the Test Set and Data Provenance
The test set consisted of cultured strains of the H3N2v Influenza A virus. The specific sample size (i.e., number of replicates for each strain) is not provided.
The data provenance is from analytical testing (e.g., in vitro laboratory testing) of cultured strains of the H3N2v influenza A virus. The origin of the data is not explicitly stated as a country, but the strains themselves suggest a US origin (West Virginia, Pennsylvania, Minnesota, Kansas, Indiana). The study is retrospective in the sense that the strains were already cultured and tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided in the document as the study described is an analytical reactivity study using cultured viral strains. The "ground truth" for the test set is the known presence and concentration of the specific influenza virus strains in the cultured samples.
4. Adjudication Method for the Test Set
This information is not applicable/provided as this was an analytical reactivity study, not a clinical study involving human interpretation of results requiring adjudication. The device's reaction (detectable or not) is a direct output.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this submission. The submission pertains to updating analytical reactivity information for an already cleared in vitro diagnostic device, not evaluating human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The OSOM® Influenza A&B Test is an immunochromatographic assay, which is a rapid diagnostic test that provides a visual result (appearance of a pink to purple line). Its performance in detecting the H3N2v strains was evaluated directly, without human interpretation in the loop beyond observing the presence or absence of the test line.
7. The Type of Ground Truth Used
The ground truth used was the known presence and estimated concentration (EID50/mL or TCID50/mL) of specific cultured influenza A viral strains, often provided by sources like the CDC. This is a form of analytical truth based on established viral culture and quantification methods.
8. The Sample Size for the Training Set
This information is not applicable/provided. The detailed analytical reactivity described is for the test set that demonstrates the device's updated capabilities. For an already cleared device, detailed training set information for its initial development and clearance (K092633) is not part of this specific submission to update labeling. The OSOM® Influenza A&B Test is a lateral flow immunoassay, not a machine learning algorithm, so the concept of a "training set" in the computational sense does not apply. If "training set" refers to samples used during the original development and optimization of the assay, that information is not present here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
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II. Statements & Certifications (continued)
B. 510(k) Summary
510(k) Summary of Safety and Effectiveness
NOV
5 2012
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K123182 The assigned 510(k) number is:
The purpose of this 510(k) submission is to update the package insert of the currently cleared OSOM® Influenza A&B test (K092633) to include additional analytical reactivity information.
1. Sponsor/Applicant Name and Address:
| Company Name: | Sekisui Diagnostics, LLC |
|---|---|
| Address: | 6659 Top Gun StreetSan Diego, CA 92121 |
| Telephone: | (858) 777-2633 |
| Fax: | (858) 452-3258 |
| Contact Person: | Mark Stavro |
Director, Regulatory Affairs
Date Summary Prepared: October 5, 2012
2. Device Name and Classification:
| Trade Name: | OSOM® Influenza A&B Test |
|---|---|
| Classification of Device: | 21CFR 866.3330,Influenza virus serological reagentsProduct Code: GNX, antigens, CF, influenzaVirus A, B, C |
| Classification Panel: | Microbiology |
| Classification: | Class I |
3. Predicate Device:
OSOM® Influenza A&B Test (K092633, cleared September 25, 2009)
9
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4. Device Description:
The OSOM® Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to Influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.
5. Device Intended Use
The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
6. Comparison to Predicate Device
The OSOM® Influenza A&B Test is the same device as the predicate OSOM® Influenza A&B Test, and no design or procedural changes have been made. The table below lists the characteristics of the OSOM® Influenza A&B Test (new Performance Characteristic) and the predicate OSOM® Influenza A&B Test (original Performance Characteristic).
| DeviceCharacteristics | New Device:OSOM® Influenza A&B Test | Predicate Device:OSOM® Influenza A&B Test(K092633) |
|---|---|---|
| Intended Use | The OSOM® Influenza A&B Test is anin- vitro diagnosticimmunochromatographic assayintended for the qualitativedetection of influenza A andinfluenza B viral nucleoproteinantigens from nasal swab specimensin symptomatic patients. It isintended to aid in the rapiddifferential diagnosis of influenza Aand/or B viral infections. This test isnot intended for the detection of | The OSOM® Influenza A&B Test is anin- vitro diagnosticimmunochromatographic assayintended for the qualitativedetection of influenza A andinfluenza B viral nucleoproteinantigens from nasal swab specimensin symptomatic patients. It isintended to aid in the rapiddifferential diagnosis of influenza Aand/or B viral infections. This test isnot intended for the detection of |
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| influenza C viruses. A negative testis presumptive and it isrecommended these results beconfirmed by cell culture. Negativeresults do not preclude influenzavirus infection and should not beused as the sole basis for treatmentor other management decisions. | influenza C viruses. A negative testis presumptive and it isrecommended these results beconfirmed by cell culture. Negativeresults do not preclude influenzavirus infection and should not beused as the sole basis for treatmentor other management decisions. | |
|---|---|---|
| Sample type | Nasal Swab | Nasal Swab |
| Analytical principle | Lateral flowimmunochromotographic assay | Lateral flowimmunochromotographic assay |
| Antibody | Mouse monoclonals | Mouse monoclonals |
| Extraction buffervolume | 300uL | 300uL |
| Read time for results | 10 minutes | 10 minutes |
| Objective Test Line | Colloidal gold | Colloidal gold |
| Internal Control | Pink to purple line | Pink to purple line |
| Control samplessupplied (asprepared swabs) | Positive Influenza APositive Influenza B(Positive A acts as negative B;Positive B acts as negative A) | Positive Influenza APositive Influenza B(Positive A acts as negative B;Positive B acts as negative A) |
Based on analytical reactivity data presented in the pre-market notification, the OSOM® Influenza A&B Test package insert has been updated to include additional analytical reactivity information for the following H3N2v Influenza A strains:
A/WEST VIRGINIA/06/2011 A/PENNSYLVANIA/14/2010 A/MINNESOTA/11/2010 A/KANSAS/13/2009 A/INDIANA/08/2011 A/INDIANA/10/2011
Results from testing demonstrated that the OSOM® Influenza A&B Test reacts with the cultured strains of the H3N2v Influenza A virus strains listed above, and all are detectable.
The Analytical Reactivity table for the influenza A strains, which is currently included in the predicate OSOM® Influenza A&B Test package insert labeling, will be updated as indicated in the table on the following page.
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Current Analytical Reactivity Table for Influenza A Strains
Updated Analytical Reactivity Table for Influenza A Strains
| InfluenzaA Strains: | Sub-type | EstimatedELISATCID50/mL |
|---|---|---|
| Beijing/262/95 | H1N1 | 8.25E+07 |
| Brazil/11/78 | H1N1 | NA |
| Chile/1/83 | H1N1 | NA |
| New Jersey/8/76 | H1N1 | 2.78E+08 |
| Taiwan/1/86 | H1N1 | 3.47E+07 |
| Guizhou/54/89 | H3N2 | 7.54E+07 |
| OMS/5389/88 | H3N2 | NA |
| Beijing/32/92 | H3N2 | 3.97E+06 |
| England/427/88 | H3N2 | 4.73E+07 |
| Johannesburg/33/94 | H3N2 | 1.61E+07 |
| Leningrad/360/86 | H3N2 | 2.50E+06 |
| Mississippi/1/85 | H3N2 | NA |
| Philippines/2/82 | H3N2 | 9.75E+07 |
| Shangdong/9/93 | H3N2 | 1.67E+08 |
| Shanghai/16/89 | H3N2 | 3.49E+08 |
| Shanghai/24/90 | H3N2 | NA |
| Sichuan/2/87 | H3N2 | NA |
| Kitakyushyu/159/93 | H3N2 | 3.19E+08 |
| Akita/1/94 | H3N2 | 2.90E+08 |
| Beijing/262/95 | H1N1 | 1.71E+08 |
| Yamagata/32/89 | H1N1 | 7.28E+07 |
| New Caledonia/20/99 | H1N1 | 6.86E+07 |
| Panama/2007/99 | H3N2 | 1.40E+08 |
| Wyoming/03/03 | H3N2 | 7.40E+06 |
| Fujian/411/02 | H3N2 | 6.12E+07 |
| Mexico/4108/2009** | H1N1 | 7.91E+06 |
| InfluenzaA Strains | Sub-type | EstimatedELISATCID50/mL |
| Beijing/262/95 | H1N1 | 8.25E+07 |
| Brazil/11/78 | H1N1 | NA |
| Chile/1/83 | H1N1 | NA |
| New Jersey/8/76 | H1N1 | 2.78E+08 |
| Taiwan/1/86 | H1N1 | 3.47E+07 |
| Guizhou/54/89 | H3N2 | 7.54E+07 |
| OMS/5389/88 | H3N2 | NA |
| Beijing/32/92 | H3N2 | 3.97E+06 |
| England/427/88 | H3N2 | 4.73E+07 |
| Johannesburg/33/94 | H3N2 | 1.61E+07 |
| Leningrad/360/86 | H3N2 | 2.50E+06 |
| Mississippi/1/85 | H3N2 | NA |
| Philippines/2/82 | H3N2 | 9.75E+07 |
| Shangdong/9/93 | H3N2 | 1.67E+08 |
| Shanghai/16/89 | H3N2 | 3.49E+08 |
| Shanghai/24/90 | H3N2 | NA |
| Sichuan/2/87 | H3N2 | NA |
| Kitakyushyu/159/93 | H3N2 | 3.19E+08 |
| Akita/1/94 | H3N2 | 2.90E+08 |
| Beijing/262/95 | H1N1 | 1.71E+08 |
| Yamagata/32/89 | H1N1 | 7.28E+07 |
| New Caledonia/20/99 | H1N1 | 6.86E+07 |
| Panama/2007/99 | H3N2 | 1.40E+08 |
| Wyoming/03/03 | H3N2 | 7.40E+06 |
| Fujian/411/02 | H3N2 | 6.12E+07 |
| Mexico/4108/2009** | H1N1 | 7.91E+06EID50/mL* |
| West Virginia/06/2011** | H3N2v | 1.0E+05* |
| Pennsylvania/14/2010** | H3N2v | 1.0E+08EID50/mL* |
| Minnesota/11/2010** | H3N2v | 1.0E+08EID50/mL* |
| Kansas/13/2009** | H3N2v | 1.0E+05* |
| Indiana/08/2011** | H3N2v | 1.0E+06EID50/mL* |
| Indiana/10/2011** | H3N2v | 1.00E+09* |
- The estimated detectable limit for the Mexico/4108/2009 strain was based on the EID50/mL stock concentration value provided by the CDC.
**Although this test has been shown to detect the 2009 H1N1 virus cultured from a positive human respiratory specimen, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The OSOM Influenza A&B test can distinguish between influenza A and B viruses, but it can not differentiate influenza subtypes.
- The estimated detectable limit for the Mexico/4108/2009 strain and these H3N2v strains were based on the EID50/mL or TCID50/mL stock concentration value provided by the CDC.
**Although this test has been shown to detect these 2009 H1N1 and H3N2v viruses cultured from positive human respiratory specimens, the performance characteristics of this device with clinical specimens that are positive for these 2009 H1N1 and H3N2v influenza viruses have not been established. The OSOM Influenza A&B test can distinguish between influenza A and B viruses, but it can not differentiate influenza subtypes.
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A copy of the updated, proposed package insert for the OSOM® Influenza A&B Test is included in Attachment 1. Please refer to Attachment 2 for a copy of the Predicate OSOM® Influenza A&B Test package insert. In addition, please refer to Attachment 4 for two additional copies of the proposed package insert for the OSOM® Influenza A&B Test for CLIA Categorization: Moderate Complexity.
7. Conclusion
The information presented in this pre-market notification demonstrates that the OSOM® Influenza A&B Test reacts with the following six additional H3N2v strains:
A/WEST VIRGINIA/06/2011 A/PENNSYLVANIA/14/2010 A/MINNESOTA/11/2010 A/KANSAS/13/2009 A/INDIANA/08/2011 A/INDIANA/10/2011
Although this test has been shown to detect these H3N2v strains in culture isolates, the performance characteristics of this device with clinical specimens that are positive for these H3N2v strains have not been established. The OSOM® Influenza A&B Test can distinguish between influenza A and B viruses, but it can not differentiate influenza subtypes. .
The OSOM® Influenza A&B Test is substantially equivalent to the predicate OSOM® Influenza A&B Test, which is cleared by the FDA (K092633) for in vitro diagnostic use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
Sekisui Diagnostics, LLC C/O Mark Stavro Director, Regulatory Affairs 6659 Top Gun St San Diego, California, 92121
NOV 5 2012
Re: K123182
Trade/Device Name: OSOM® Influenza A&B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Code: GNX Dated: October 5th, 2012 Received: October 10th, 2012
Dear Mr. Stavro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a views of the determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of to togal) in the Medical Device Amendments, or to conniner of that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (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 r no general connects proving 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 r your device is blubsitive (600 acre). Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. 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 I Toast be advised that I Dr 8 155 lossantes vour device complies with other requirements of the Act that I DA has made a actornmantions administered by other Federal agencies. You must or any I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fatt 607), mooning (21 OFR 803); good manufacturing practice requirements as set Gevice-related daverse ovents) (2) CFR Part 820); and if applicable, the electronic form in the quarty of oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and ir you desire specific acrited for your City of Intern Diagnostics and Radiological Health at (301) 796-007), production of the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
under the MDR regulation (21 Of N Patt 603), products of the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the r ou may obtain only general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally A. Hojvat
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Statements & Certifications ==
A. Statement of Intended Use
510(k) Number (if known): _K123182
OSOM® Influenza A&B Test Device Name:
The OSOM® Influenza A&B Test is an in vitro diagnostic Indications for Use: Immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. lt is intended to aid in the rapid differential diagnosis of Influenza A and/or B viral infections.
This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use_ (per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Tamara Feldblum
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
8
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.