Who is the manufacturer of SAS FLUALERT A & B, SAS INFLUENZA A TEST?

Sa Scientific , Ltd. filed the 510(k) submission for SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352).

What is the FDA product code for SAS FLUALERT A & B, SAS INFLUENZA A TEST?

GNX. It is classified under 21 CFR 866.3330 as a Class 1 device in the Microbiology panel.

What is the regulatory pathway for SAS FLUALERT A & B, SAS INFLUENZA A TEST?

510(k) clearance (submission type: Special).

What are the predicate devices for SAS FLUALERT A & B, SAS INFLUENZA A TEST?

SAS™ Influenza A Test (K041441); SAS™ FluAlert A & B Test (K080380).

Who can help prepare an FDA 510(k) submission like SAS FLUALERT A & B, SAS INFLUENZA A TEST?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SAS FLUALERT A & B, SAS INFLUENZA A TEST

K132352 · Sa Scientific , Ltd. · GNX · Aug 22, 2013 · Microbiology

Device Facts

Record ID	K132352
Device Name	SAS FLUALERT A & B, SAS INFLUENZA A TEST
Applicant	Sa Scientific , Ltd.
Product Code	GNX · Microbiology
Decision Date	Aug 22, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 866.3330
Device Class	Class 1

Intended Use

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

Visual, rapid lateral flow immunoassays for qualitative detection of influenza A (or A and B) nucleoprotein antigens in nasal wash/aspirate specimens. Professional use in clinical settings. Device utilizes internal procedural controls. Modification involves updated labeling to include analytical reactivity (LoD) data for H7N9 (A/Anhui/1/2013) influenza strain. Testing performed using non-infectious beta-propiolactone inactivated virus. Output is visual result read by clinician at 15 minutes. Results are presumptive; negative results require confirmation by cell culture. Device does not differentiate influenza subtypes.

Clinical Evidence

Bench testing only. Analytical sensitivity (Limit of Detection) determined for 2013 H7N9 (A/Anhui/1/2013) using serial dilutions in extraction buffer. Cross-reactivity studies performed against various respiratory viruses and other influenza strains. Performance characteristics with clinical specimens positive for 2013 H7N9 have not been established.

Technological Characteristics

Visual lateral flow immunoassay. Detects viral nucleoprotein antigens. Specimen types: nasal wash, nasal aspirate. Read time: 15 minutes. Includes internal positive and negative procedural controls. No changes to materials or physical characteristics.

Indications for Use

Indicated for symptomatic patients requiring presumptive in-vitro qualitative detection of influenza A (and B for FluAlert) viral nucleoprotein antigens from nasal washes and nasal aspirates. For professional, prescription use only.

Regulatory Classification

Identification

Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

Predicate Devices

SAS™ Influenza A Test (K041441)
SAS™ FluAlert A & B Test (K080380)

Related Devices

K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST · Sa Scientific, Inc. · Feb 23, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ K132B52 ### 510(k) SUMMARY SASTM Influenza A Test K041441 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 Quail San Antonio, TX 78240 210-699-8800 | | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Establishment Reg. No: | 1645225 | | | Contact Person: | Nelson Torres | AUG 2 2 2013 | | Date Prepared: | July 22, 2013 | | | Proprietary Name: | SASTM Influenza 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 Committee: | Microbiology | | | Product Code: | GNX | | | Substantial Equivalence: | SASTM Influenza A Test, manufactured by SA Scientific, Ltd., San Antonio, TX. | | | Device Description: | The SASTM Influenza A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM Influenza 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. | | | Intended Use: | SASTM Influenza 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. | | {1}------------------------------------------------ | | 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. | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conditions for Use: | For prescription use only. | | Quality Controls: | The SASTM Influenza A Test provides an internal procedural quality control. It is recommended that external quality controls be assayed following the user's laboratory's standard quality control procedures and in conformance with local, state and federal regulations or accreditation organizations as applicable | | Device comparison: | The SASTM Influenza A is a rapid immunoassays utilizing immunochromatographic technology for the visualization of influenza A antigen. Each utilizes an antibody conjugated to colored particles and an antibody printed onto a membrane. The chemistry of the predicate device and the proposed device is identical; the only difference is that the new inserts include sensitivity data for H7N9. | | Performance Summary: | This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) 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 virus, but cannot differentiate influenza subtypes. | | Clinical Summary: | Please see K041441 for Clinical Summary | #### Note: Performance characteristics for detecting the 2013 H7N9 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 2013 H7N9 using strain A/Anhui/1/2013. Each strain was serially diluted in SAS™ Influennza A extraction buffer. Results for A/Anhui/1/2013 are included in the summary table below. | Influenza Viral Strain | ATCC | LoD TCID50/0.2 ml | |----------------------------|----------------------|-------------------------------| | H1N1 A/PR/3/34 | VR-95 | $1.2 \times 10^5$ | | H3N2 A/Aichi/2/68 | VR-547 | $5.6 \times 10^2$ | | H3N2 A/Hong Kong/8/6/8 | VR-544 | $3.5 \times 10^3$ | | H1N1 A/FM/147 | VR-97 | $7.9 \times 10^3$ | | H3N2 A/Victoria/3/75 | VR-822 | $4.5 \times 10^5$ | | H1N1 A/California/04/09 | NR-13658 | $1.4 \times 10^3$ | | H7N9 A/Anhui/1/2013 | CDC ID 2013759189 | $1.0 \times 10^8$ EID50/mL | *This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS Influenza A Test can detect influenza A viruses, but cannot differentiate influenza subtypes. ** This viral strain was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer. {2}------------------------------------------------ Conclusion: The information presented in the premarket notification demonstrates that the SAS™ Influenza A Test reacts with a cultured strain of 2013 H7N9 (Influenza A/Anhui/1/2013). Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS Influenza A Test can detect influenza A viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer. {3}------------------------------------------------ ### 510(k) SUMMARY SAS™ FluAlert A & B Test K080380 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 Quail San Antonio, TX 78240 210-699-8800 | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Reg. No: | 1645225 | | Contact Person: | Nelson Torres | | Date Prepared: | July 22, 2013 | | Proprietary Name: | SASTM FluAlert A & 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 | | Classification Advisory Committee: | Microbiology | | Product Code: | GNX | | Substantial Equivalence: | Substantially equivalent to the SASTM FluAlert A&B Test, manufactured by SA Scientific, Ltd., San Antonio, TX. | | Device Description: | The SASTM FluAlert A & B Test utilizes antibodies against influenza type A and influenza type B viral nucleoproteins. After the extraction has been completed, the sample is placed into two separate sample wells. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for either influenza A or influenza B viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A or influenza B nucleoproteins, respectively, which bind the "half sandwich" complex. Thus, in the presence of influenza 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 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 or influenza B nucleoproteins. | | Intended Use: | SAS™ FluAlert A & B Test is a visual and rapid assay for the presumptive in- vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only. | | | Negative results do not preclude infection with influenza A and/or influenza B 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. | | Conditions for Use: | For prescription use only. | | Quality Controls: | The SASTM Influenza A & Influenza B Test provides two (2) internal procedural quality controls. It is recommended that external quality controls be assayed following the user's laboratory's standard quality control procedures and in conformance with local, state and federal regulations or accreditation organizations as applicable | | Device comparison: | The SASTM FluAlert A&B Test is a rapid immunoassay tests utilizing immunochromatographic technology for the visualization of Influenza A & Influenza B viral nucleoprotein antigens. Each utilizes an antibody conjugated to colored particles and an antibody printed onto a membrane. The chemistry of the predicate devices and the proposed device is identical; the only difference is that the new inserts include sensitivity data for H7N9. | | Performance Summary: | This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen. However, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. | | Clinical Summary: | Please see K080380 for Clinical Summary | : {4}------------------------------------------------ #### Note: Performance characteristics for detecting the 2013 H7N9 influenza virus from human specimens have not been established Analytical Sensitivity (Limit of Detection): The analytical sensitivity for the SAS™ FluAlert A&B Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. 'The strain was received from the CDC with a known EIDso concentration but was not verified by SA Scientific. The strain was serially diluted in SAS™ FluAlert extraction buffer and assayed using the SAS™ FluAlert A&B Test. Results for A/Anhui/1/2013 are included in the summary table below. | Influenza Viral Strain | ATCC | LoD 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 Kong/8/6/8 | VR-544 | $3.5 x 10^3$ | | H1N1 A/FM/147 | VR-97 | $7.9 x 10^3$ | | H3N2 A/Victoria/3/75 | VR-822 | $4.5 x 10^5$ | | H1N1 A/California/04/09 | NR-13658 | $1.4 x 10^3$ | | *H7N9 A/Anhui/1/2013 | CDC ID 2013759189 | ** $1.0 X 10^8$ EID50/mL | | Influenza B B/Lee/40 | VR-101 | $9.9 x 10^4$ | {5}------------------------------------------------ | Influenza B B/Allen/45 | VR-102 | $5.6 x 10^2$ | |--------------------------------|--------|--------------| | Influenza B B/Mass/3/66 | VR-523 | $4.5 x 10^2$ | | Influenza B B/Taiwan/2/62 | VR-295 | $3.5 x 10^1$ | | Influenza B B/Maryland/1/59 | VR-296 | $1.6 x 10^2$ | *This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. ** This viral strain was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer. Cross Reactivity Study: The cross-reactivity for the SAS™ FluAlert A&B Test was determined for 2013 H7N9 using strain A/Anhui/1/2013. The cultured viral strain was tested on the SASTM FluAlert A&B Test at the indicated concentrations. The cross-reactivity of A/Anhui/1/2013 in the "B" potion of the SAS™ FluAlert A&B Test was added to the summary table below. | Virus | ATTC/Lot # | Concentration | "A" portion of the SASTM FluAlert A&B | "B" portion of the SASTM FluAlert A&B | |--------------------------|------------|-------------------------------------|---------------------------------------------|---------------------------------------------| | Adenovirus 5 | 10-198-000 | $1.2 x 10^{10}$ | Neg | Neg | | Adenovirus 7 | VR7 | 3.2 x $10^3$ TCID50 /0.2 ml | Neg | Neg | | Adenovirus 10 | VR1087 | 3.2 x $10^3$ TCID50 /0.2 ml | Neg | Neg | | CoxsackieA9 | VR186 | 3.2 x $10^2$ TCID50 /0.2 ml | Neg | Neg | | CoxsackieB5 | VR185 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | Neg | | Cytomegalovirus | 021301 | 20 µg/ml | Neg | Neg | | Echovirus 11 | VR1052 | NA | Neg | Neg | | Echovirus3 | VR1040 | 1 x $10^4$ TCID50 /0.2 ml | Neg | Neg | | Echovirus 6 | VR1044 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | Neg | | HSV-1 | 2J30000 | 15 µg/ml | Neg | Neg | | HSV-2 | 8J29502 | 15 µg/ml | Neg | Neg | | Varicella zoster | 1102097 | 12 µg/ml | Neg | Neg | | Parainfluenza 1 | VR907 | 5.6 x $10^6$ TCID50 /0.2 ml | Neg | Neg | | Parainfluenza 2 | VR92 | 1.8 x $10^5$ TCID50 /0.2 ml | Neg | Neg | | Parainfluenza 3 | VR93 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | Neg | | RSV Long | VR26 | 0.1 x $10^{5.5}$ TCID50 /0.2 ml | Neg | Neg | | RSV B | VR1400 | 0.1 x $10^{5.25}$ TCID50 /0.2 ml | Neg | Neg | | Influenza B Allen | VR102 | 3.2 x $10^3$ TCID50 /0.2 ml | Neg | | | Influenza B Lee | VR101 | 3.2 x $10^6$ TCID50 /0.2 ml | Neg | | | Influenza B Mass | VR523 | 1.8 x $10^3$ TCID50 /0.2 ml | Neg | | | Influenza B Maryland | VR296 | 1 x $10^4$ TCID50 /0.2 ml | Neg | | | Influenza B Taiwan | VR295 | 5.6 x $10^2$ TCID50 /0.2 ml | Neg | | | Influenza A (H1N1) PR | VR95 | 1.8 x $10^4$ TCID50 /0.2 ml | | Neg | {6}------------------------------------------------ | Influenza A (H3N2) Aichci | VR547 | $1.8 x 10^6$ TCID50/0.2 ml | Neg | |-------------------------------------------|----------------------|-----------------------------|-----| | Influenza A (H3N2) Hong Kong | VR544 | $5.6 x 10^4$ TCID50 /0.2 ml | Neg | | Influenza A FM | VR97 | $3.2 x 10^4$ TCID50 /0.2 ml | Neg | | Influenza A (H3N2) Victoria | VR822 | $1.8 x 10^6$ TCID50 /0.2 ml | Neg | | Influenza A (H1N1) California/04/09 | NR-13658 | $1.1 x 10^4$ TCID50 /0.2 ml | Neg | | Influenza A (H7N9) Anhui/1/2013 | CDC ID 2013759189 | 1.0 X $10^9$ EID50/ ml | Neg | *This test has been shown to detect the Influenza A/Anhui/1/2013 (H7N9) virus cultured from a positive human specimen however, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. ** This viral strain was obtained from the CDC 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&B Test reacts with a cultured strain of 2013 H7N9 (FluA/Anhui/1/2013). There is no cross-reactivity observed on the "B" portion of the SAS™ FluAlert A&B Test. Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established. The SAS FluAlert A&B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. This viral strain used in this study was obtained from the CDC with a known titer. SA Scientific, Ltd did not verify this titer. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W()666-(i609 Silver Spring, MI) 20993-0002 NELSON TORRES QA/RA SPECIALIST SA SCIENTIFIC 4919 GOLDEN QUAIL SAN ANTONIO TX 78240 August 22,2013 Re: K132352 Trade/Device Names: SAS " Influenza A and SAS" FluAlert A & B Tests Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: 1 Product Code: GNX Dated: July 22, 2013 Received: August 2, 2013 Dear Mr. Torres: We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, subject to the general approvisions 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading. If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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 devices comply 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {8}------------------------------------------------ Page 2-Mr. Torres If you desire specific advice for your devices on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Sally A. Hojvat -S Sally Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ## Indications for Use Form 510(k) Number: __ K132352 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: SASTM FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A and/or influenza B 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 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Tamara V. Feldblyum -S 2013.08.20 15:36:18 -04'00' Page 1 of 1 - {10}------------------------------------------------ # Indications for Use Form 510(k) Number: K132352 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: SASTM Influenza 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 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Tamara V. Feldblyum -S 2013.08.20 15:38:43 -04'00' Page 1 of 1 __

SAS FLUALERT A & B, SAS INFLUENZA A TEST

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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SAS FLUALERT A & B, SAS INFLUENZA A TEST

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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