OSOM INFLUENZA A&B TEST MODEL 190

K123182 · SEKISUI Diagnostics, LLC · GNX · Nov 5, 2012 · Microbiology

Device Facts

• Record ID: K123182
• Device Name: OSOM INFLUENZA A&B TEST MODEL 190
• Applicant: SEKISUI Diagnostics, LLC
• Product Code: GNX · Microbiology
• Decision Date: Nov 5, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

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.

Device Story

The OSOM® Influenza A&B Test is a lateral flow immunochromatographic assay for qualitative detection of influenza A and B viral nucleoproteins. The procedure involves solubilizing viral antigens from a nasal swab in an extraction buffer. The test stick is immersed in the sample, which migrates along a nitrocellulose membrane. If influenza A or B antigens are present, they bind to colloidal gold-conjugated mouse monoclonal IgG antibodies, forming a complex captured by secondary antibodies on the membrane. Results are visualized as pink to purple lines: a control line confirms validity, while test lines indicate positive results for A, B, or both. The test is performed in a clinical setting by healthcare professionals. It provides rapid results (10 minutes) to aid in differential diagnosis. Negative results are presumptive and require confirmation by cell culture; results should not be the sole basis for clinical management decisions.

Clinical Evidence

Bench testing only. The device was tested against cultured 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 demonstrated that the test detects these cultured strains. Performance characteristics with clinical specimens positive for these specific H3N2v strains have not been established.

Technological Characteristics

Lateral flow immunochromatographic assay. Materials: mouse monoclonal antibodies, colloidal gold. Sample: nasal swab. Extraction buffer: 300uL. Read time: 10 minutes. Visual readout (pink/purple line). No electronic components or software.

Indications for Use

Indicated for symptomatic patients requiring rapid differential diagnosis of influenza A and/or B viral infections via nasal swab specimens. Not indicated for detection of influenza C viruses.

Regulatory Classification

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.

Predicate Devices

• OSOM® Influenza A&B Test (K092633)

Submission Summary (Full Text)

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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 Street<br>San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| 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,<br>Influenza virus serological reagents<br>Product Code: GNX, antigens, CF, influenza<br>Virus A, B, C |
| Classification Panel: | Microbiology |
| Classification: | Class I |

## 3. Predicate Device:

OSOM® Influenza A&B Test (K092633, cleared September 25, 2009)

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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).

| Device<br>Characteristics | New Device:<br>OSOM® Influenza A&B Test | Predicate Device:<br>OSOM® Influenza A&B Test<br>(K092633) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The OSOM® Influenza A&B Test is an<br>in- vitro diagnostic<br>immunochromatographic assay<br>intended for the qualitative<br>detection of influenza A and<br>influenza B viral nucleoprotein<br>antigens from nasal swab specimens<br>in symptomatic patients. It is<br>intended to aid in the rapid<br>differential diagnosis of influenza A<br>and/or B viral infections. This test is<br>not intended for the detection of | The OSOM® Influenza A&B Test is an<br>in- vitro diagnostic<br>immunochromatographic assay<br>intended for the qualitative<br>detection of influenza A and<br>influenza B viral nucleoprotein<br>antigens from nasal swab specimens<br>in symptomatic patients. It is<br>intended to aid in the rapid<br>differential diagnosis of influenza A<br>and/or B viral infections. This test is<br>not intended for the detection of |

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| | influenza C viruses. A negative test<br>is presumptive and it is<br>recommended these results be<br>confirmed by cell culture. Negative<br>results do not preclude influenza<br>virus infection and should not be<br>used as the sole basis for treatment<br>or other management decisions. | influenza C viruses. A negative test<br>is presumptive and it is<br>recommended these results be<br>confirmed by cell culture. Negative<br>results do not preclude influenza<br>virus infection and should not be<br>used as the sole basis for treatment<br>or other management decisions. |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Nasal Swab | Nasal Swab |
| Analytical principle | Lateral flow<br>immunochromotographic assay | Lateral flow<br>immunochromotographic assay |
| Antibody | Mouse monoclonals | Mouse monoclonals |
| Extraction buffer<br>volume | 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 samples<br>supplied (as<br>prepared swabs) | Positive Influenza A<br>Positive Influenza B<br>(Positive A acts as negative B;<br>Positive B acts as negative A) | Positive Influenza A<br>Positive Influenza B<br>(Positive A acts as negative B;<br>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

| Influenza<br>A Strains: | Sub-type | Estimated<br>ELISA<br>TCID50/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 |
| Influenza<br>A Strains | Sub-type | Estimated<br>ELISA<br>TCID50/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<br>EID50/mL* |
| West Virginia/06/2011** | H3N2v | 1.0E+05* |
| Pennsylvania/14/2010** | H3N2v | 1.0E+08<br>EID50/mL* |
| Minnesota/11/2010** | H3N2v | 1.0E+08<br>EID50/mL* |
| Kansas/13/2009** | H3N2v | 1.0E+05* |
| Indiana/08/2011** | H3N2v | 1.0E+06<br>EID50/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 [phone] or [phone] 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

K123182

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