OSOM INFLUENZA A&B TEST

K061508 · Genzyme Corp. · PSZ · Jun 12, 2006 · Microbiology

Device Facts

• Record ID: K061508
• Device Name: OSOM INFLUENZA A&B TEST
• Applicant: Genzyme Corp.
• Product Code: PSZ · Microbiology
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

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

Lateral flow immunochromatographic assay for rapid differential diagnosis of influenza A and B. Input: nasal swab specimen. Process: specimen solubilized in extraction buffer; test stick inserted; viral antigens bind to colloidal gold-conjugated mouse monoclonal IgG antibodies; complex captured by membrane-bound antibodies. Output: visual pink/purple lines on test stick indicating presence of influenza A, B, or both; control line validates test. Used in clinical settings by healthcare professionals. Provides rapid results (10 minutes) to aid clinical decision-making; negative results require confirmatory cell culture.

Clinical Evidence

Bench testing only. Performance evaluated via cross-reactivity testing against various viral and bacterial entities, including Adenovirus, Coxsackievirus, Echovirus, Measles, Mumps, Parainfluenza, Rhinovirus, and RSV. No clinical trial data provided in the summary.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: test stick, nitrocellulose membrane, mouse monoclonal IgG antibodies, colloidal gold conjugate. Specimen: nasal swab. Time to result: 10 minutes. Qualitative visual readout (pink/purple lines).

Indications for Use

Indicated for qualitative detection of influenza A and B viral nucleoprotein antigens in nasal swab specimens from symptomatic patients. 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

• OSOM Influenza A&B Test (K051244)

Submission Summary (Full Text)

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K061508

JUN 12 2 2066

OSOM® Influenza A&B Test 510(k)

#### 510(K) SUMMARY SECTION C.

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.

- Sponsor/Applicant Name and Address: 1. Genzyme Corporation One Kendall Square Cambridge, MA 02139
- Sponsor Contact Information: 2. Fred D. Lasky, Ph.D. Director, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]
- Date of Preparation of 510(k) Summary: 3. May 31, 2006
- 4. Device Trade or Proprietary Name: OSOM Influenza A&B Test
- Legally Marketed Devices to which Equivalence is Being Claimed: న. OSOM Influenza A&B Test (K 051244)

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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. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

## 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.

### 7. Comparison of Technological Characteristics of Genzyme OSOM Influenza A&B Test with Legally Marketed Device:

The similarities with, and differences between, the OSOM Influenza A&B Test, with revised labeling, and the OSOM Influenza A&B Test (K 051244) device are described in the following table.

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:

| | OSOM Influenza A&B Test | OSOM Influenza A&B Test<br>(K051244) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The OSOM Influenza A&B Test<br>is an 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<br>specimens in symptomatic<br>patients. It is intended to aid in<br>the rapid differential diagnosis of<br>influenza A and/or B viral<br>infections. This test is not<br>intended for the detection of<br>influenza C viruses. A negative<br>test is presumptive and it is<br>recommended these results be<br>confirmed by cell culture.<br>Negative results do not preclude<br>influenza virus infection and<br>should not be used as the sole<br>basis for treatment or other<br>management decisions. | Intended for the qualitative<br>detection of influenza A and<br>influenza B viral antigens from<br>nasal swab specimens. It is<br>intended to aid in the rapid<br>differential diagnosis of<br>influenza A and/or B viral<br>infections. The test is for use in<br>clinical laboratories, health<br>clinics, and physician office<br>laboratories. |
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Specimen | nasal swabs | nasal swabs |
| Antibodies (labeled<br>and capture) | Mouse monoclonals | Mouse monoclonals |
| Conjugate | Colloidal gold | Colloidal gold |
| Objective Test Line | Pink to purple line | Pink to purple line |
| Internal Control | Yes - Pink to purple line | Yes - Pink to purple line |
| Time To Result | 10 minutes | 10 minutes |
| Cross-reactivity data | Includes test listing of bacterial<br>and viral entities | Includes test listing of bacterial<br>entities |

Summary of Device Similarities and Differences

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# genzyme

#### Potential Interfering Substances 8.

The following potential cross-reactant viruses were tested at levels greater than the limits of detection of the OSOM Influenza A&B Test for both influenza A and B (4.4 x 10*/test and 1.4 x 105/test, respectively), and were found to have no affect on the performance.

| Virus |
|-----------------------------|
| Adenovirus Type 1 |
| Adenovirus Type 2 |
| Adenovirus Type 3 |
| Adenovirus Type 6 |
| Coxsackievirus B2 |
| Coxsackievirus B3 |
| Coxsackievirus B4 |
| Coxsackievirus B5 |
| Echovirus Type 6 |
| Echovirus Type 11 (Gregory) |
| Echovirus 30 |
| Measles virus |
| Mumps virus (Enders strain) |
| Parainfluenza virus Type 1 |
| Parainfluenza virus Type 3 |
| Parainfluenza virus Type 4B |
| Rhinovirus 3 |
| Rhinovirus 7 |
| RSV (Long strain) |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure, composed of several curved lines.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 12 2006

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

Re: k061508

> 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: May 31, 2006 Received: June 1. 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 Hom

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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Indications for Use

6 1508 510(k) Number (if known):

Device Name: OSOM Influenza A&B Test

Indications for 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.

Prescription Use X

(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 OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off

Page | of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_ KO 1504