(51 days)
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.
The SAS™ Influenza B test utilizes a set monoclonal antibodies against Influenza Type B viral nucleoproteins. The SAS™ Influenza test begins with an extraction of Type B nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type B nucleoproteins. If Type B nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type B nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza B nucleoproteins.
Acceptance Criteria and Study for SAS™ Influenza B Test
The provided document describes the SAS™ Influenza B Test, an immunoassay for the presumptive qualitative detection of Influenza Type B antigens. The primary study presented aims to demonstrate substantial equivalence to a predicate device, the Binax™ NOW® Flu B Test.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or positive/negative predictive values. Instead, the acceptance criterion appears to be demonstrating substantial equivalence to the predicate device. The performance summary indirectly addresses this by stating the device performed "substantially equivalent" when compared to the predicate using freshly collected nasal wash specimens.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance Statement |
|---|---|---|
| Equivalence | Substantial equivalence to predicate device (Binax™ NOW® Flu B Test) | "The SAS™ Influenza B test performed substantially equivalent to the predicate device, Binax™ NOW® Flu B test." |
| Cross-Reactivity | No interference or cross-reaction with common respiratory viral and bacterial strains. | "None of the organisms interfered or cross-reacted with the performance of the SAS™ Influenza B test." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document indicates that the comparison was made using "freshly collected nasal wash specimens." The exact number of specimens is not provided.
- Data Provenance: The data is described as using "freshly collected nasal wash specimens," implying the data is prospective in nature. The country of origin is not specified, but the submission is from SA Scientific, Inc. in San Antonio, TX, USA, suggesting the data is likely from the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense (e.g., expert consensus on images). Instead, the study's ground truth for comparison is likely derived from the predicate device's results, or potentially in conjunction with a more definitive method like viral culture, though culture is only mentioned for confirming negative results in the "Indications for Use."
4. Adjudication Method for the Test Set
No adjudication method is described. The study appears to be a direct comparison of the investigational device's results against the predicate device's results, or against a reference standard without mention of a formal adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a rapid immunoassay test, which typically provides a single, objective result (positive/negative) without requiring interpretation by multiple readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The SAS™ Influenza B Test is a visual immunoassay that produces a direct result. Its performance is evaluated intrinsically through its ability to detect the target antigen, not as an algorithm assisting a human. The performance summary describes its direct comparison to the predicate device, indicating a standalone evaluation.
7. Type of Ground Truth Used
The primary ground truth for establishing substantial equivalence was likely the results from the predicate device (Binax™ NOW® Flu B Test) using the same "freshly collected nasal wash specimens." While the "Indications for Use" section states that "Negative results should be confirmed via culture," it's not explicitly stated that viral culture was used as the definitive ground truth for the equivalence study itself, but rather as a clinical follow-up for specific results.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a rapid immunoassay device, not a machine learning or AI algorithm. Therefore, no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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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.4919 Golden QuailSan 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™Inc., Portland, Maine. |
| Device Description: | The SAS™ Influenza B test utilizes a set monoclonal antibodiesagainst Influenza Type B viral nucleoproteins. The SAS™Influenza test begins with an extraction of Type Bnucleoproteins. After the extraction has been completed, thesample is placed into the test and observed for the formation ofcolored lines. The specimen is absorbed and migrates viacapillary action through a membrane that contains dried goldconjugated antibody, which is specific for Influenza Type Bnucleoproteins. If Type B nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane containsimmobilized antibody to Influenza Type B nucleoproteins, whichbinds the "half sandwich" complex. Thus, in the presence ofInfluenza nucleoproteins, a "whole sandwich" immuno-complexis formed and a visible, pink colored line develops in thespecimen zone of the test device. In the absence of an Influenzaantigen, a "sandwich" immuno-complex is not formed and anegative result is indicated. To serve as a procedural control, apink colored control line will always appear in the control zoneregardless of the presence or absence of Influenza Bnucleoproteins. |
| Intended Use: | SAS™ Influenza B Test is a visual and rapid assay for thepresumptive qualitative detection of Influenza Type B antigensfrom nasal washes and aspirates. Negative results should be |
| confirmed via culture. This test is not intended for the detectionof Influenza Type A or C viral antigen. | |
| Quality Controls: | The SAS™ Influenza B test provides two (2) internal proceduralquality controls. It is recommended that external quality controlsshould be assayed at least once per lot. |
| Device comparison: | The SAS™ Influenza B and Binax™ NOW® Flu B tests are rapidimmunoassays tests utilizing immunochromatographictechnology for the visualization of Influenza B antigen. Eachutilizes an antibody conjugated to colored particles and anantibody printed onto a membrane. |
| Performance Summary: | The SAS™ Influenza B test performed substantially equivalentto the predicate device, Binax™ NOW® Flu B test. This wasverified by comparison to freshly collected nasal washspecimens.Cross reactivity and interference studies were performed on viraland bacterial strains commonly found in the human respiratorytract. None of the organisms interfered or cross-reacted with theperformance 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of
| 510(k) | K041439 |
|---|---|
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§ 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.