SAS FLUALERT A&B, SAS INFLUENZA A TEST

K100227 · Sa Scientific, Inc. · PSZ · Feb 23, 2010 · Microbiology

Device Facts

• Record ID: K100227
• Device Name: SAS FLUALERT A&B, SAS INFLUENZA A TEST
• Applicant: Sa Scientific, Inc.
• Product Code: PSZ · Microbiology
• Decision Date: Feb 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

Intended Use

The SAS FluAlert A Test is a lateral flow immunoassay for the qualitative detection of influenza A virus nucleoprotein antigen in nasal swab and nasopharyngeal swab specimens. It is intended to aid in the rapid diagnosis of influenza A viral infections. The test is intended for use by healthcare professionals as an aid to diagnosis. This test is CLIA Waived.

Device Story

Lateral flow immunochromatographic assay; detects influenza A viral nucleoproteins in nasal washes/aspirates. Sample extraction followed by application to test well; specimen migrates via capillary action through membrane containing gold-conjugated anti-influenza A antibodies. Formation of 'half-sandwich' immunocomplex occurs if antigen present; immobilized antibodies on membrane capture complex to form 'whole-sandwich' immunocomplex, resulting in visible pink line in specimen zone. Procedural control line appears on every strip. Used in clinical settings by healthcare professionals. Provides rapid qualitative results to assist clinical decision-making; negative results require culture confirmation. Benefits include rapid presumptive identification of influenza A.

Clinical Evidence

Bench testing only. Analytical sensitivity updated to include reactivity data for 2009 H1N1 Influenza strain (A/California/04/09). No clinical performance data established for 2009 H1N1 detection.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: gold-conjugated antibodies, membrane with immobilized antibodies. Qualitative visual readout. Standalone test device. No electronic components or software.

Indications for Use

Indicated for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens in nasal washes and nasal aspirates from symptomatic patients. For professional use only. Not for detection of Influenza B or C. Negative results 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

• SASTM FluAlert A Test (K100227)

Submission Summary (Full Text)

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## FEB 2 3 2010

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SASTM FluAlert A 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, Ltd.<br>4919 Golden Quail<br>San Antonio, TX 78240<br>210-699-8800 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Reg. No: | 1645225 |
| Contact Person: | Robbi Perry |
| Date Prepared: | January 22, 2010 |
| Proprietary Name: | SASTM FluAlert A Test |
| Classification Name: | Antigens, CF (including CF control), Influenza virus A, B, C |
| Device Classification: | 21 CFR Part 866.3330 |
| Regulatory Class: | Class I |
| Classification Advisory<br>Committee: | Microbiology |
| Product Code: | GNX |
| Substantial Equivalence: | SASTM FluAlert A Test, manufactured by SA Scientific, Ltd., San Antonio, TX. |
| Device Description: | The SASTM FluAlert A Test utilizes antibodies against influenza type A viral<br>nucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type A<br>nucleoproteins. After the extraction has been completed, the sample is placed<br>into the sample well of the test. The specimen is absorbed and migrates via<br>capillary action through membranes that contain dried gold conjugated antibody,<br>which is specific for influenza A viral nucleoproteins. If these nucleoproteins<br>are present, a "half-sandwich" immunocomplex is formed. The membrane<br>contains immobilized antibody to influenza A nucleoproteins, which binds the<br>"half sandwich" complex. Thus, in the presence of influenza A nucleoproteins,<br>a "whole sandwich" immunocomplex is formed and a visible, pink-colored line<br>develops in the specimen zone of the test device. In the absence of an influenza<br>A antigen, a "sandwich" immunocomplex is not formed and a negative result is<br>indicated. To serve as a procedural control, a pink-colored control line will<br>always appear in the control zone of each strip regardless of the presence or<br>absence of influenza A nucleoproteins. |
| Intended Use: | SASTM FluAlert A Test is a visual and rapid assay for the presumptive in-vitro<br>qualitative detection of influenza A viral nucleoprotein antigens from nasal<br>washes and nasal aspirates of symptomatic patients. Negative results should be<br>confirmed via culture. This test is not intended for the detection of Influenza |
| | Negative results do not preclude infection with influenza A and should not be<br>used as the sole basis for treatment or other patient management decisions. It is<br>recommended that negative results be confirmed by cell culture. |
| Conditions for Use: | For prescription use only. |
| Quality Controls: | The SAST™ FluAlert A Test provides an internal procedural quality control. It is<br>recommended that external quality controls be assayed following the user's<br>laboratory's standard quality control procedures and in conformance with local,<br>state and federal regulations or accreditation organizations as applicable |
| Device comparison: | The SAST™ FluAlert A is a rapid immunoassays utilizing<br>immunochromatographic technology for the visualization of influenza A<br>antigen. Each utilizes an antibody conjugated to colored particles and an<br>antibody printed onto a membrane. |
| Performance Summary: | This test has been shown to detect the FluA/California/04/2009 (H1N1) virus<br>cultured from a positive human specimen however, the performance<br>characteristics of this test with clinical specimens that are positive for the 2009<br>H1N1 influenza virus have not been established. The SAS FluAlert A Test can<br>detect influenza A virus, but cannot differentiate influenza subtypes. |
| Clinical Summary: | Please see K041441 for Clinical Summary |

Type B or Influenza Type C viral antigen. This test is for professional use only.

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## Note: Performance characteristics for detecting the 2009 H1N1 influenza virus from human specimens have not been established

Analytical Sensitivity

(Limit of Detection):

The analytical sensitivity of the SAS™ FluAlert A Test was determined for 2009 HIN1 using strain A/California/04/09. 2009 H1N1 using strain A/California/04/09. Each strain was serially diluted in SASTM FluAlert A extraction buffer. Results for A/California/04/09 are included in the summary table below.

| Influenza<br>Viral Strain | ATCC | LoD<br>TCID50/0.2 ml |
|----------------------------|----------|----------------------|
| H1N1 A/PR/3/34 | VR-95 | $1.2 x 10^5$ |
| H3N2 A/Aichi/2/68 | VR-547 | $5.6 x 10^2$ |
| H3N2 A/Hong<br>Kong/8/6/8 | VR-544 | $3.5 x 10^3$ |
| H1N1 A/FM/147 | VR-97 | $7.9 x 10^3$ |
| H3N2<br>A/Victoria/3/75 | VR-822 | $4.5 x 10^5$ |
| H1N1<br>A/California/04/09 | NR-13658 | $1.4 x 10^3$ |

*This test has been shown to detect the FluA/California/04/2009 (H1N1) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2009 HINI influenza virus have not been established. The SAS FluAlert A Test can detect influenza A viruses, but cannot differentiate influenza subtypes.

** This viral strain was obtained from ATCC with a known titer. SA Scientific, Ltd did not verify this titer.

Conclusion:

The information presented in the premarket notification demonstrates that the SASTM FluAlert A Test reacts with a cultured strain of 2009 HIN1

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(FluA/California/04/2009). Although this test has been shown to detect the 2009 H1N1 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The SAS FluAlert A Test can detect influenza A viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from ATCC with a known titer. SA Scientific, Ltd did not verify this titer. ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

.

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Image /page/3/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 is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

FEB 2 3 2010

SA Scientific, Inc. c/o Ms. Robbi Perry MT (ASCP) Regulatory Affairs Specialist 4919 Golden Quail San Antonio, Texas 78240

Re: k100227

Trade/Device Name: SAS FluAlert A Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: February 23, 2010 Received: January 26, 2010

Dear Ms. Perry:

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) 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); 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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Robbi Perry

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Une Sich Rv

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

2 100 227 510(k) Number (if known):

Device Name: SAS™ FluAlert A Test

Indication For Use:

SAS™ FluAlert A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_