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

Indications for 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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SPECIAL 510(k): Device Modification

To: THE FILE

RE: DOCUMENT NUMBER K100227

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: SAS FluAlert A Test (K041441).

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED. However there were modifications of the limitations for SAS FluAlert A Test (K041441).

3. The modification of the device consisted of expanded analytical sensitivity table to include reactivity information for the 2009 H1N1 Influenza strain (A/California/04/09). This modification has not had any effect or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device.

4. Comparison Information (similarities and differences):

a) There were no changes made to the device SAS FluAlert A Test (K041441)
b) Reactivity data for 2009 H1N1 was added to the analytical sensitivity table.
c) Limitations were updated to reflect the reactivity data stating performance characteristics for detecting the 2009 H1N1 influenza virus directly from human specimens have not been established.
d) Limitations for Influenza A test (K041441) in the CLIA waved and Moderate complexity product insert were updated for consistency.

5. A declaration of conformity with design controls.

Sponsor provided a signed statement that:

e) All verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
f) The manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

Sponsor provided a signed Truthful and Accurate Statement, updated 510(k) summaries, and Indications for Use Enclosures.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. I recommend the device be determined substantially equivalent to the previously cleared device.