SAS INFLUENZA B TEST

K041439 · Sa Scientific, Inc. · PSZ · Jul 22, 2004 · Microbiology

Device Facts

• Record ID: K041439
• Device Name: SAS INFLUENZA B TEST
• Applicant: Sa Scientific, Inc.
• Product Code: PSZ · Microbiology
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

Intended Use

SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen.

Device Story

Lateral flow immunochromatographic assay for Influenza B detection. Input: nasal wash or aspirate specimens. Process: extraction of viral nucleoproteins; capillary migration through membrane containing gold-conjugated anti-Influenza B antibodies; formation of 'half-sandwich' complex; binding to immobilized antibodies on membrane to form 'whole-sandwich' complex. Output: visual pink line in specimen zone indicates positive result; pink line in control zone confirms procedural validity. Used in clinical settings by professionals. Results provide presumptive diagnosis; negative results require culture confirmation.

Clinical Evidence

Bench testing only. Performance verified by comparison to predicate device using freshly collected nasal wash specimens. Cross-reactivity and interference studies conducted on common human respiratory tract viral and bacterial strains; no cross-reactivity or interference observed.

Technological Characteristics

Lateral flow immunochromatographic assay. Utilizes monoclonal antibodies against Influenza Type B viral nucleoproteins. Gold-conjugated antibody detection system. Visual readout via colored lines. Internal procedural quality controls included.

Indications for Use

Indicated for professional use for the presumptive qualitative detection of Influenza Type B antigens in nasal wash and aspirate specimens. Not indicated for detection of Influenza Type A or C.

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

• Binax™ NOW® Flu B Test (K021649)

Submission Summary (Full Text)

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**JUL 22 2004**

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

KO41439

SAS™ Influenza B Test

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

| Submitted by: | SA Scientific, Inc.<br>4919 Golden Quail<br>San Antonio, TX 78240 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Reg. No. : | 1645225 |
| Contact Person: | Ricardo R. Martinez |
| Date Prepared: | August 14, 2003 |
| Proprietary Name: | SAS™ Influenza B Test |
| Common Name: | SAS™ Influenza B Test, SAS™ Flu B Test |
| Classification Name: | Antigens, CF (including CF Control), Influenza virus A, B, C |
| Device Classification: | 21 CFR Part 866.3330 |
| Regulatory Class: | Class I |
| Product Code: | GNX |
| Substantial Equivalence: | Binax™ NOW® Flu B Test (K021649) manufactured by Binax™<br>Inc., Portland, Maine. |
| Device Description: | The SAS™ Influenza B test utilizes a set monoclonal antibodies<br>against Influenza Type B viral nucleoproteins. The SAS™<br>Influenza test begins with an extraction of Type B<br>nucleoproteins. After the extraction has been completed, the<br>sample is placed into the test and observed for the formation of<br>colored lines. The specimen is absorbed and migrates via<br>capillary action through a membrane that contains dried gold<br>conjugated antibody, which is specific for Influenza Type B<br>nucleoproteins. If Type B nucleoproteins are present, a "half-<br>sandwich" immuno-complex is formed. The membrane contains<br>immobilized antibody to Influenza Type B nucleoproteins, which<br>binds the "half sandwich" complex. Thus, in the presence of<br>Influenza nucleoproteins, a "whole sandwich" immuno-complex<br>is formed and a visible, pink colored line develops in the<br>specimen zone of the test device. In the absence of an Influenza<br>antigen, a "sandwich" immuno-complex is not formed and a<br>negative result is indicated. To serve as a procedural control, a<br>pink colored control line will always appear in the control zone<br>regardless of the presence or absence of Influenza B<br>nucleoproteins. |
| Intended Use: | SAS™ Influenza B Test is a visual and rapid assay for the<br>presumptive qualitative detection of Influenza Type B antigens<br>from nasal washes and aspirates. Negative results should be |
| | confirmed via culture. This test is not intended for the detection<br>of Influenza Type A or C viral antigen. |
| Quality Controls: | The SAS™ Influenza B test provides two (2) internal procedural<br>quality controls. It is recommended that external quality controls<br>should be assayed at least once per lot. |
| Device comparison: | The SAS™ Influenza B and Binax™ NOW® Flu B tests are rapid<br>immunoassays tests utilizing immunochromatographic<br>technology for the visualization of Influenza B antigen. Each<br>utilizes an antibody conjugated to colored particles and an<br>antibody printed onto a membrane. |
| Performance Summary: | The SAS™ Influenza B test performed substantially equivalent<br>to the predicate device, Binax™ NOW® Flu B test. This was<br>verified by comparison to freshly collected nasal wash<br>specimens.<br><br>Cross reactivity and interference studies were performed on viral<br>and bacterial strains commonly found in the human respiratory<br>tract. None of the organisms interfered or cross-reacted with the<br>performance of the SAS™ Influenza B test. |

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Ricardo R. Martinez, Director Regulatory Affairs

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 2004

Mr. Ricardo R. Martinez Director, Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240

Re: k041439

Trade/Device Name: SASTM Influenza B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: Class I Product Code: GNX Dated: July 7, 2004 Received: July 16, 2004

Dear Mr. Martinez:

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/dsma/dsmamain.html.

Sincerely yours,

Sagarths

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

510(k) Number (if known): K041439

SAS™ Influenza B Test Device Name:

Indications For Use:

SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen. The test is for professional use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Devic Evaluation and Safety

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| 510(k) | K041439 |
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