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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the OSOM® Influenza A&B Test, primarily focusing on updating the package insert with additional analytical reactivity information for the H1N1 Influenza A strain Mexico/4108/2009.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it demonstrates the device's analytical reactivity with a specific strain of influenza. The acceptance is based on the device showing reactivity to the H1N1 strain.

Acceptance Criteria (Implied)	Reported Device Performance
Detect the H1N1 Influenza A strain Mexico/4108/2009 in culture.	OSOM Influenza A&B Test reacts with a cultured strain of the 2009 H1N1 Influenza A virus (A/Mexico/4108/2009) and is detectable.

2. Sample Sizes and Data Provenance

Test Set Sample Size: The document refers to testing with a "cultured strain" (A/Mexico/4108/2009) of the 2009 H1N1 Influenza A virus. It does not specify a "sample size" in terms of number of patient samples, but rather indicates a single viral strain was used for this analytical reactivity test.
Data Provenance: The data is analytical reactivity information, presumably from a laboratory setting. Specific country of origin is not mentioned for this particular test, but the strain name "Mexico/4108/2009" indicates the origin of the virus strain. The study is a prospective analytical study, not a retrospective clinical study.

3. Number of Experts and Qualifications

Not applicable. This was an analytical reactivity study, not a study requiring expert interpretation of results. The determination of whether the test "reacts" is a direct laboratory observable.

4. Adjudication Method

Not applicable. There was no need for adjudication as this was an analytical reactivity study, not a clinical study involving multiple interpreters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes an analytical reactivity study, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

6. Standalone Performance Study

Yes. The study described is a standalone analytical performance study, demonstrating the device's ability to detect the H1N1 strain in a cultured sample without human intervention in the result interpretation (beyond observing the test line).

7. Type of Ground Truth Used

The ground truth used was the cultured presence of the specific H1N1 Influenza A virus strain (A/Mexico/4108/2009). This is a laboratory-established ground truth.

8. Sample Size for the Training Set

Not applicable. This device is an immunochromatographic assay, not an AI/machine learning algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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B. 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K092633

The purpose of this 510(k) submission is to update the package insert to include additional analytical reactivity information of the currently cleared 510(k) OSOM® Influenza A&B Test (510(k) K061508).

Sponsor/Applicant Name and Address 1.

Company Name: Address:

Telephone: Fax:

Contact Person:

Genzyme Corporation 500 Kendall Street Cambridge, MA 01242 (858) 777-2611 (858) 452-3258

Fil V. Buenviaje Manager, Regulatory Affairs

Date Summary Prepared:

August 20, 2009

Device Name and Classification 2.

Trade Name:

OSOM Influenza A&B Test

Classification of Device:

21 CFR 866.3330, Influenza virus serological reagents Product Code: GNX, antigens, CF, influenza Virus A, B, C

Classification Panel:

Classification:

Class I

Microbiology

Predicate Device 3.

OSOM® Influenza A&B Test (K061508, cleared June 12, 2006)

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Device Description 4.

Device Intended Use ડ.

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.

Comparison to Predicate Device 6.

The OSOM® Influenza A&B Test is the same device as the predicate OSOM Influenza A&B Test, no physical or procedural changes have been made. The OSOM Influenza A&B Test Package Insert has been updated to include additional analytical reactivity information.

The OSOM Influenza A&B Test was tested with the H1N1 Influenza A strain Mexico/4108/2009. Results demonstrate that OSOM Influenza A&B test reacts with a cultured strain of the 2009 H1N1 Influenza A virus (A/Mexico/4108/2009) and is detectable.

Thus, OSOM Influenza A&B Test is substantially equivalent to OSOM Influenza I has, OUGH Infrasal swabs, which was cleared by the FDA (K061508) for in vitro diagnostic use.

The Table lists the characteristics of the OSOM® Influenza A&B Test (new The Fable the the characteristic) and the OSOM® Influenza A&B Test (original Performance Characteristic).

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DeviceCharacteristics	New DeviceOSOM Influenza A&B Test	Predicate DeviceOSOM Influenza A&B Test
Intended Use	The OSOM Influenza A&B Testis an in vitro diagnosticimmunochromatographic assayintended for the qualitativedetection of influenza A andinfluenza B viral nucleoproteinantigens from nasal swabspecimens in symptomaticpatients. It is intended to aid inthe rapid differential diagnosis ofinfluenza A and/or B viralinfections. This test is notintended for the detection ofinfluenza C viruses. A negativetest is presumptive and it isrecommended these results beconfirmed by cell culture.Negative results do not precludeinfluenza virus infection andshould not be used as the solebasis for treatment or othermanagement decisions.	The OSOM Influenza A&B Test isan in vitro diagnosticimmunochromatographic assayintended for the qualitativedetection of influenza A andinfluenza B viral nucleoproteinantigens from nasal swabspecimens in symptomaticpatients. It is intended to aid in therapid differential diagnosis ofinfluenza A and/or B viralinfections. This test is not intendedfor the detection of influenza Cviruses. A negative test ispresumptive and it isrecommended these results beconfirmed by cell culture.Negative results do not precludeinfluenza virus infection andshould not be used as the solebasis for treatment or othermanagement decisions.
Sample type	Nasal swab	Nasal swab
Analytical principle	Lateral flowimmunochromotographic assay	Lateral flowimmunochromotographic assay
Antibody	Mouse monoclonals	Mouse monoclonals
Extraction buffervolume	300 uL	300 uL
Read time	10 minutes	10 minutes
Procedural control	Yes	Yes
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)

and the comments of the comments of the comments of

September 19.

and the comments of the comments of the country of

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Addition to AnalyticalReactivity table(predicate device):	Analytical Reactivity table:
	InfluenzaA Strains:	Sub-type	EstimatedELISATCID50/mL
Mexico/4108/2009H1N1 7.91E+06EID50/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

Conclusion 7.

The information presented in the premarket notification demonstrates that the OSOM Influenza A&B test reacts with a cultured strain of the 2009 H1N1 Influenza A virus (A/Mexico/4108/2009). Although this test has been shown to detect the 2009 H1N1 (irus in culture isolates, the performance characteristics of this device with clinical specimens that are positive for the 2009 HIN1 influenza virus have not been specifiched. The OSOM Influenza A&B test can distinguish between influenza A and B viruses, but it can not differentiate influenza subtypes.

The information presented in the pre-market notification demonstrates that the OSOM Influenza A&B test is substantially equivalent with the current OSOM Influenza A&B test.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three lines that curve upwards and to the right, resembling a stylized bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

SEP 2 5 2009

Fil V. Buenviaje, RAC Manager, Regulatory Affairs Genzyme Diagnostics 6659 Top Gun Street San Diego, CA 92121

Re: K092633

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: August 20, 2009 Received: August 27, 2009

Dear Mr. Buenviaje:

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 class II (Special Controls), 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 Division of Small Manufacturers, International 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,

Salla Htijin

Sally A. Hojvat, 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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Statement of Intended Use

Page 1 of 1

510(k) Number (if known): K092633

Device Name:

OSOM® Influenza A&B Test

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

OR
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety510(k).

K092633

Regulation Number and Section

§ 866.3328 Influenza virus antigen detection test system.

(a)
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.(b)
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.