SAS FLUALERT A&B, SAS INFLUENZA A TEST by SA SCIENTIFIC, INC.

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.

Device Description

The SASTM FluAlert A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex 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 of each strip regardless of the presence or absence of influenza A nucleoproteins.

AI/ML Overview

The provided text describes the SASTM FluAlert A Test, a rapid immunoassay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SASTM FluAlert A Test are based on its analytical sensitivity (Limit of Detection - LoD) for various influenza A viral strains. The reported performance demonstrates the concentration at which the device can detect these strains.

Influenza Viral Strain	ATCC	Acceptance Criteria (LoD TCID50/0.2 ml)	Reported Device Performance (LoD TCID50/0.2 ml)
H1N1 A/PR/3/34	VR-95	Not explicitly stated (implied to be detected)	$1.2 \times 10^5$
H3N2 A/Aichi/2/68	VR-547	Not explicitly stated (implied to be detected)	$5.6 \times 10^2$
H3N2 A/Hong Kong/8/6/8	VR-544	Not explicitly stated (implied to be detected)	$3.5 \times 10^3$
H1N1 A/FM/147	VR-97	Not explicitly stated (implied to be detected)	$7.9 \times 10^3$
H3N2 A/Victoria/3/75	VR-822	Not explicitly stated (implied to be detected)	$4.5 \times 10^5$
H1N1 A/California/04/09	NR-13658	Not explicitly stated (implied to be detected)	$1.4 \times 10^3$

Note: The document implies that the device is intended to "detect" these strains, thus the acceptance criteria are that the device demonstrates a measurable Limit of Detection for each. The specific numerical thresholds for acceptance were not explicitly defined as pass/fail criteria in the provided text, but the reported LoD values demonstrate the device's capability.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes an analytical sensitivity study (Limit of Detection) rather than a clinical test set with human samples.

Sample Size for the test set: For each influenza viral strain tested, the study involved serial dilutions to determine the Limit of Detection (LoD). The exact number of replicates or individual test instances at each dilution is not specified, but the methodology implies multiple tests per dilution series to establish the LoD.
Data Provenance: The strains tested were obtained from ATCC (American Type Culture Collection), a global non-profit biological resource center. These are cultured viral strains, not directly human clinical samples. The document states "a positive human specimen" was used to culture the FluA/California/04/2009 (H1N1) virus, but the LoD study itself used the cultured strain rather than direct clinical specimens for this particular virus. The study is therefore retrospective in the sense that it uses established and archived viral strains. The country of origin of the ATCC strains is not specified in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no human experts used to establish ground truth for this particular analytical sensitivity study. The ground truth was established by the known titers of the viral strains obtained from ATCC. The document states: "This viral strain used in this study was obtained from ATCC with a known titer. SA Scientific, Ltd did not verify this titer."

4. Adjudication Method for the Test Set

Not applicable. This was an analytical study determining the Limit of Detection using cultured viral strains with known titers, not a study involving human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is an analytical sensitivity study of the device's ability to detect specific viral strains, not a study comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this was a standalone performance study from the perspective of the device. The study evaluated the SASTM FluAlert A Test's ability to detect influenza A viral nucleoprotein antigens without human interpretation being part of the primary measurement for the LoD. The "visual" aspect of the assay implies a human performs the reading, but the study focuses on the lowest concentration the device can detect, independent of variations in human interpretation during clinical use.

7. The Type of Ground Truth Used

The type of ground truth used was known viral titers provided by ATCC for the various influenza A strains. This is a form of analytical ground truth, based on established biological standards.

8. The Sample Size for the Training Set

No information is provided about a "training set" in the context of machine learning or algorithm development. The SASTM FluAlert A Test is described as an "immunoassay utilizing immunochromatographic technology," which typically means it relies on biochemical reactions (antibody-antigen binding) rather than an AI algorithm that requires a training set.

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

Not applicable, as no training set for an AI algorithm appears to have been used in the development or evaluation of this immunoassay device.

Summary

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Kluozz7

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.4919 Golden QuailSan Antonio, TX 78240210-699-8800
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 AdvisoryCommittee:	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 viralnucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type Anucleoproteins. After the extraction has been completed, the sample is placedinto the sample well of the test. The specimen is absorbed and migrates viacapillary action through membranes that contain dried gold conjugated antibody,which is specific for influenza A viral nucleoproteins. If these nucleoproteinsare present, a "half-sandwich" immunocomplex is formed. The membranecontains immobilized antibody to influenza A nucleoproteins, which binds the"half sandwich" complex. Thus, in the presence of influenza A nucleoproteins,a "whole sandwich" immunocomplex is formed and a visible, pink-colored linedevelops in the specimen zone of the test device. In the absence of an influenzaA antigen, a "sandwich" immunocomplex is not formed and a negative result isindicated. To serve as a procedural control, a pink-colored control line willalways appear in the control zone of each strip regardless of the presence orabsence of influenza A nucleoproteins.
Intended Use:	SASTM FluAlert A Test is a visual and rapid assay for the presumptive in-vitroqualitative detection of influenza A viral nucleoprotein antigens from nasalwashes and nasal aspirates of symptomatic patients. Negative results should beconfirmed via culture. This test is not intended for the detection of Influenza
	Negative results do not preclude infection with influenza A and should not beused as the sole basis for treatment or other patient management decisions. It isrecommended 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 isrecommended that external quality controls be assayed following the user'slaboratory's standard quality control procedures and in conformance with local,state and federal regulations or accreditation organizations as applicable
Device comparison:	The SAST™ FluAlert A is a rapid immunoassays utilizingimmunochromatographic technology for the visualization of influenza Aantigen. Each utilizes an antibody conjugated to colored particles and anantibody printed onto a membrane.
Performance Summary:	This test has been shown to detect the FluA/California/04/2009 (H1N1) viruscultured from a positive human specimen however, the performancecharacteristics of this test with clinical specimens that are positive for the 2009H1N1 influenza virus have not been established. The SAS FluAlert A Test candetect 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.

InfluenzaViral Strain	ATCC	LoDTCID50/0.2 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/HongKong/8/6/8	VR-544	$3.5 x 10^3$
H1N1 A/FM/147	VR-97	$7.9 x 10^3$
H3N2A/Victoria/3/75	VR-822	$4.5 x 10^5$
H1N1A/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 (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 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:

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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

Uhe Schlf
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_

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.