GENZYME OSOM INFLUENZA A & B TEST

K051244 · Genzyme Corp. · PSZ · Feb 21, 2006 · Microbiology

Device Facts

• Record ID: K051244
• Device Name: GENZYME OSOM INFLUENZA A & B TEST
• Applicant: Genzyme Corp.
• Product Code: PSZ · Microbiology
• Decision Date: Feb 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3328
• Device Class: Class 2
• Attributes: Pediatric

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. Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.

Device Story

Lateral flow immunochromatographic assay for rapid differential diagnosis of influenza A and B. Input: nasal swab specimen solubilized in extraction buffer. Principle: viral nucleoproteins migrate along a membrane; bind to colloidal gold-conjugated mouse monoclonal IgG antibodies; captured by secondary mouse anti-influenza antibodies on nitrocellulose. Output: visual pink/purple test lines (A, B, or both) and a control line. Used in clinical laboratories, health clinics, and physician offices by healthcare personnel. Provides rapid (10-minute) qualitative results to aid clinical decision-making; negative results require culture confirmation. Benefits: rapid identification of influenza A/B infections to guide patient management.

Clinical Evidence

Clinical study of 383 subjects (pediatric and adult) compared OSOM test to viral culture. For Influenza A: 73.8% sensitivity, 96.4% specificity. For Influenza B: 60.0% sensitivity, 96.4% specificity. Reproducibility study across four sites (nurses, practitioners, physicians) showed 97% accuracy for Flu A and 94% for Flu B. Analytical testing included 25 bacterial isolates and 46 influenza strains.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: test stick, extraction buffer, mouse monoclonal IgG antibodies, colloidal gold conjugate, nitrocellulose membrane. Dimensions/form factor: test stick. Connectivity: none (standalone). Sterilization: not specified. Software: none.

Indications for Use

Indicated for qualitative detection of influenza A and B viral nucleoprotein antigens in symptomatic patients using nasal swab specimens. Not for influenza C detection. Negative results are presumptive and require confirmation by cell culture.

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.

Predicate Devices

• Quidel QuickVue™ Influenza A+B Test (K031899)

Submission Summary (Full Text)

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OSOM Influenza A&B Test 510(k)

K 05/244

# 510(K) SUMMARY

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the OSOM® Influenza A&B Test.

- 1. Sponsor/Applicant Name and Address: Genzyme Corporation One Kendall Square Cambridge, MA 02139
- 2. Sponsor Contact Information: Fred D. Lasky, Ph.D. Director, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]
- 3. Date of Preparation of 510(k) Summary: May 13, 2005
- 4. Device Trade or Proprietary Name: OSOM Influenza A&B Test
- న్. Legally Marketed Devices to which Equivalence is Being Claimed: Quidel QuickVue™ Influenza A+B Test (K 031899)

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#### 6. Device Description:

#### 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.

Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.

#### Principle of the Device

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.

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- Comparison of Technological Characteristics of Genzyme OSOM Influenza A&B Test 8. with Legally Marketed Device:
The similarities with, and differences between, the OSOM Influenza A&B Test and the Quidel QuickVue® Influenza A+B Test device are described in Table 1. Table 1: Summary of Device Similarities and Differences

| | OSOM Influenza A&B Test | Quidel QuickVue® Influenza A+B Test |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for the qualitative<br>detection of influenza A and<br>influenza B viral antigens<br>from nasal swab specimens.<br>It is intended to aid in the<br>rapid differential diagnosis of<br>influenza A and/or B viral<br>infections. The test is for use<br>in clinical laboratories, health<br>clinics, and physician office<br>laboratories. | Intended for the rapid,<br>qualitative detection of<br>influenza type A and<br>influenza type B antigens<br>from nasal swab, nasal wash<br>and/or nasal aspirate<br>specimens. This test is<br>intended for use as an aid in<br>the rapid differential<br>diagnosis of acute influenza<br>type A and type B virus<br>infection. |
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Specimen | - nasal swabs | - nasal swabs<br>- nasal wash<br>- nasal aspirate |
| Antibodies (labeled<br>and capture) | Mouse monoclonals | Mouse monoclonals |
| Conjugate | Colloidal gold | Latex |
| Objective Test Line | Pink to purple line | Red line |
| Internal Control | Yes -- red line | Yes – blue line |
| Time To Result | 10 minutes | 10 minutes |

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#### Agreement with Viral Culture: 9.

The performance of the OSOM Influenza A&B Test was analyzed compared to viral culture for both influenza A and influenza B. Samples analyzed were from nasal swabs. The results of the comparison of the OSOM Influenza A&B Test are:

| | Nasal Swab | |
|-------------|--------------------------|--------------------------|
| | Influenza A<br>(n = 383) | Influenza B<br>(n = 383) |
| Sensitivity | 73.8% | 60.0% |
| Specificity | 96.4% | 96.4% |
| Agreement | 90.1% | 91.6% |

A total of 383 subjects were enrolled in the study. Of the 383 samples were from pediatric subjects (2-19 years) and 251 samples were from adults (> 20 years). The OSOM Influenza A&B Test was compared to cell culture to determine the comparative clinical sensitivity and clinical specificity for detection of influenza A and influenza B in nasal swab specimens.

| Flu A | | | |
|---------------|-----|----------|-------|
| OSOM | | Culture | |
| Influenza A&B | A+ | Negative | Total |
| A+ | 79 | 91 | 88 |
| A+B+ | 0 | 12 | 1 |
| Negative | 283 | 266 | 294 |
| Total | 107 | 276 | 383 |

# Comparison of OSOM Influenza A&B Test to Cell culture: Nasal Swab

Clinical sensitivity: 73.8% (79/107)

(95% CI 64.4% - 81.9%)

Clinical specificity: 96.4%. (266/276)

(95% CI 93.4% - 98.2%)

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Polymerase Chain Reaction (PCR) was performed on specimens that gave inconsistent results. This assay is not FDA approved or cleared. These results are provided for information only.

| PCR Results: | 1 5 Positive, 4 Negative | |
|--------------|------------------------------------------|--|
| | 2 1 Negative | |
| | 3 24 Positive, 2 Negative, 1 B Positive, | |
| | 1 Quantity Not Sufficient (QNS) | |

| Flu B | | | |
|--------------------------|---------------|----------|-------|
| OSOM<br>Influenza<br>A&B | Culture<br>B+ | Negative | Total |
| B+ | 30 | 114 | 41 |
| A+B+ | 0 | 15 | 1 |
| Negative | 206 | 321 | 341 |
| Total | 50 | 333 | 388 |

Clinical sensitivity: 60.0% (30/50)

(95% Cl 45.2-73.6%)

Clinical specificity: 96.4% (321/333)

(95% CI 93.8% - 98.1%)

Polymerase Chain Reaction (PCR) was performed on specimens that gave inconsistent results. This assay is not FDA approved or cleared. These results are provided for information only.

> 4 10 Positive, 1 Negative PCR Results: 5 1 Negative 6 19 Positive, 1 Negative

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# Assay Reproducibility

A reproducibility proficiency study was conducted to demonstrate that the OSOM Influenza A&B Test will perform acceptably in the hands of nurses, nurse practitioners and physicians' office personnel. A panel of swabs including negative (no virus), strong negative (below the limit of detection), low (near the limit of detection) and mid viral levels for influenza A and B were coded and masked to the operators. This study was conducted with three operators at three health centers in the eastern United States (2 physician's offices and 1 clinic site) and at Genzyme Diagnostics. The overall accuracy was 97% for flu A and 94% for flu B. Two invalid tests were considered as incorrect results in each analysis. We never saw the education level and experience of the testers, This is a CLIA waver labeling issue.

| | Correct<br>Response<br>for Flu A | | Lower 95%<br>Confidence<br>Interval | Upper 95%<br>Confidence<br>Interval |
|----------------|----------------------------------|--------|-------------------------------------|-------------------------------------|
| A - Strong Neg | 12/12 | 100.0% | 73.0% | 100.0% |
| A - Low | 23/24* | 95.8% | 78.9% | 99.9% |
| A - Med | 11/12* | 91.7% | 61.5% | 99.8% |
| B - Strong Neg | 12/12 | 100.0% | 73.0% | 100.0% |
| B - Low | 23/24 | 95.8% | 78.9% | 99.9% |
| B - Med | 11/12 | 91.7% | 61.5% | 99.8% |
| AB - Med | 12/12 | 100.0% | 73.0% | 100.0% |
| Negative | 48/48 | 100.0% | 92.5% | 100.0% |
| Total | 152/156* | 97.4% | 93.6% | 99.3% |

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*invalids due to insufficient volume or no control line

### Analytical Specificity and Cross-reactivity

The OSOM Influenza A&B Test was evaluated with 25 bacterial isolates. Bacterial isolates were tested at a concentration of approximately ... 108 cfu/mL.. Very high levels of Staphylococcus aureus (>9x108 cfu/mL) produced a positive result. All other bacteria listed gave negative responses. Cross-reactivity with other known respiratory viruses was not evaluated. Only influenza isolates were tested.

| <b>Bacterial Panel:</b> | |
|-----------------------------|----------------------------|
| Acinetobacter calcoaceticus | tuberculosis |
| Bordetella pertussis | Neisseria meningitidis |
| Candida albicans | Proteus mirabilis |
| Corynebacterium diphteriae | Proteus vulgaris |
| Enterococcus faecalis | Pseudomonas aeruginosa |
| Enterococcus gallinarum | Serratia marcescens |
| Escherichia coli | Staphylococcus aureus |
| Haemophilus influenza | Staphylococcus epidermidis |
| Klebsiella pneumoniae | Streptococcus Group A |
| Legionella pneumophilia | Streptococcus Group B |
| Moraxella catarrhalis | Streptococcus mutans |
| Mycobacterium avium | Streptococcus pneumoniae |
| Mycobacterium | Torulopsis glabrata |

### Influenza A/B Panel testing

A total of 46 human and animal influenza strains were tested with the OSOM Influenza A & B test. Viral titers (TCID50) for A/Kitakyushu/159/93 (H3N2) and B/Lee/40 were determined by inoculating MDCK cells, followed by standard procedures for cell culture viral assays. Aliquots of these controls with known TCID50 were then used to establish a standard curve in an ELISA assay. The concentrations of other influenza viruses were determined indirectly using the ELISA assay after the viruses had been inactivated. Influenza viruses were tested at an ELISA estimated TCID50 as listed in the table below.

All influenza virus isolates gave positive results with the test line at the expected location for the A, B and animal (positive for influenza A) isolates.

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| Influenza A strains: | Sub-<br>type | Estimated<br>ELISA<br>TCID50/mL | Influenza B strains: | Sub-<br>type | Estimated<br>ELISA<br>TCID50/mL |
|------------------------|--------------|---------------------------------|----------------------------------|--------------|---------------------------------|
| Beijing/262/95 | H1N1 | 8.25E+07 | Ann Arbor/1/86 | | NA |
| Brazil/11/78 | H1N1 | NA | Beijing1/87 | | 1.04E+07 |
| Chile/1/83 | H1N1 | NA | Guangdong/120/200<br>0 | | 6.44E+07 |
| New Jersey/8/76 | H1N1 | 2.78E+08 | Hongkong/8/73 | | 1.74E+07 |
| Taiwan/1/86 | H1N1 | 3.47E+07 | Panama/45/90 | | 3.79E+07 |
| Guizhou/54/89 | H3N2 | 7.54E+07 | Singapore/222/79 | | 4.84E+07 |
| OMS/5389/88 | H3N2 | NA | Yamagata/16/88 | | 1.78E+07 |
| Beijing/32/92 | H3N2 | 3.97E+06 | Lee/40 | | 2.13E+08 |
| England/427/88 | H3N2 | 4.73E+07 | Mie/1/93 | | 4.84E+07 |
| Johannesburg/33/94 | H3N2 | 1.61E+07 | Guangdong/05/94 | | 1.27E+07 |
| Leningrad/360/86 | H3N2 | 2.50E+06 | Johannesburg/5/99 | | 5.87E+07 |
| Mississippi/1/85 | H3N2 | NA | Shandong/7/97 | | 4.41E+07 |
| Philippines/2/82 | H3N2 | 9.75E+07 | Shanghai/361/2002 | | NA |
| Shangdong/9/93 | H3N2 | 1.67E+08 | Animal<br>influenza strains: | Sub-<br>type | Estimated<br>ELISA<br>TCID50/mL |
| 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<br>Caledonia/20/99 | H1N1 | 6.86E+07 | | | |
| Panama/2007/99 | H3N2 | 1.40E+08 | A/Duck/Singapore-<br>Q/F119-3/97 | H5N3 | 1.65E+08 |
| Wyoming/03/03 | H3N2 | 7.40E+06 | A/Equine/Prague/56 | H7N7 | 5.37E+06 |
| Fujian/411/02 | H3N2 | 6.12E+07 | A/Duck/Wisconsin/1<br>120/82 | H5N3 | 2.30E+08 |
| | | | A/Hong<br>Kong/483/97 | H5N1 | 1.06E+08 |
| | | | A/Hong<br>Kong/213/2003 | H5N1 | 1.84E+08 |
| | | | A/Turkey/Ontario/71 | H7N3 | 8.12E+07 |
| | | | A/Mallard/Wisconsin/479/79 | H7N3 | 2.08E+08 |
| | | | A/Mallard/Saskatchewan/38/81 | H7N3 | 2.46E+08 |

Although this test has been shown to detect cultured avian influenza viruses, including avian influenza A subtype H5N1 virus, the performance characteristics of this test with specimens from humans infected with H5N1 or other avian influenza viruses are unknown

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# Interfering Substances

The following potential interferents were tested and were found to have no affect on the performance of the OSOM Influenza A&B Test.

| Potential Interferent | Concentration |
|---------------------------|---------------|
| Acetyl salicylic Acid | 20 mg/mL |
| Acetamidophenol | 10 mg/mL |
| Chlorpheniramine maleate | 5 mg/mL |
| Dextromethorphan HBr | 20 mg/mL |
| Diphenhydramine HCl | 5 mg/mL |
| Ephedrine HCl | 20 mg/mL |
| Guiacol Glyceryl Ether | 20 mg/mL |
| Oxymetazoline HCl | 10 mg/mL |
| Phenylephrine HCl | 100 mg/mL |
| Phenylpropanolamine | 20 mg/mL |
| Whole Blood | 2% |
| OTC Throat Drops | |
| Throat Drop (Halls) | 25% |
| Throat Drop (Zinc) | 25% |
| Throat Drop (Ricola) | 25% |
| OTC Nasal Sprays | |
| Nasal Spray (Zicam) | 10% |
| Nasal Spray (Afrin) | 10% |
| Nasal Spray (Vicks Sinex) | 10% |

Note: A very high hemoglobin concentration could interfere with the interpretation of the test result.

## Analytical Sensitivity

Dilutions of influenza A Kitakyushyu/159/93 (H3N2) and for influenza B Lee/40 virus were run in triplicate on three lots of the OSOM Influenza A&B Test. The approximate detection limits of the OSOM Influenza A&B Test are 4.4 x 104 TCID50/test for influenza A and 1.44 x 105 TCID50/test for influenza B.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three overlapping, curved lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the bird.

Public Health Service

ood and Drug Administrat 2098 Gaither Road Rockville MD 20850

FEB 2 1 2006

Fred D. Lasky, Ph.D Director of Regulatory Affairs Genzyme Corporation 500 Kendall Street Cambridge, MA 02142

Re: k051244

Trade/Device Name: OSOM® Influenza A&B Test Regulation Number: 21CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: February 13, 2006 Received: February 15, 2006

Dear Dr. Lasky:

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).

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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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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 story

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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genzyme

STATEMENT OF INDICATIONS FOR USE

# Indications for Use

510(k) Number (if known): KOSIZAY

OSOM® Influenza A&B Test Device Name: -------------

Indications For Use: k 051244

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.

Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.

AND/OR

Prescription Use >> (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

510(k)________________________________________________________________________________________________________________________________________________________________________