← Product Code [GNX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX) · K132352 # SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352) _Sa Scientific , Ltd. · GNX · Aug 22, 2013 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K132352 ## Device Facts - **Applicant:** Sa Scientific , Ltd. - **Product Code:** [GNX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX.md) - **Decision Date:** Aug 22, 2013 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.3330 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## Indications for 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. ## Regulatory 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](/device/K041441.md)) - SAS™ FluAlert A & B Test ([K080380](/device/K080380.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(k): Device Modification Decision Summary To: SA Scientific RE: K132352 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II devices requiring 510(k)s. The following items are present and acceptable 1. The names and 510(k) numbers of the SUBMITTER'S previously cleared devices: Trade Names: SAS™ Influenza A Test SAS™ FluAlert A & B Test 510(k) numbers: K041441 K080380 2. Submitter's statement that the INDICATION/INTENDED USES of the modified devices as described in their labeling HAVE NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling. 3. A description of the device MODIFICATION(S). The modification presented in this 510(k) consisted of expanded analytical sensitivity (limit of detection; LoD) tables to include reactivity information for the H7N9 influenza A virus. The ability of the SAS Influenza A Test and the SAS FluAlert A & B Test to detect H7N9 influenza A virus was tested using the (A/Anhui/1/2013) strain obtained from the Centers for Disease Control and Prevention as non-infectious beta-propiolactone inactivated virus. An LoD study was performed with the A/Anhui/1/2013 influenza strain at concentrations: - 5x10⁷ EID₅₀/mL - 1x10⁸ EID₅₀/mL - 2x10⁸ EID₅₀/mL The LoD was determined to be 1x10⁸ EID₅₀/mL. The package inserts for the SAS Influenza A Test and the SAS FluAlert A & B Test have been updated to include the additional analytical reactivity information 4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified devices has not changed. 5. Comparison Information (similarities and differences) to applicant's legally marketed predicate devices including, labeling, intended use, and physical characteristics: Similarities - SAS Influenza A Test (K041441) | Features | SAS Influenza A Test | SAS Influenza A Test | | --- | --- | --- | | 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 | 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 | {1} 2 | | 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. | 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. | | --- | --- | --- | | Read Results | Visual | Visual | | Specimen Types | Nasal wash, nasal aspirate | Nasal wash, nasal aspirate | | Read Result Time | 15 minutes | 15 minutes | | Internal Controls | Device includes an internal positive and negative procedural control | Device includes an internal positive and negative procedural control | ## Similarities - SAS FluAlert A & B Test (K080380) | Features | SAS FluAlert A & B Test | SAS FluAlert A & B Test | | --- | --- | --- | | 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. | 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. | | Read Results | Visual | Visual | | Specimen Types | Nasal wash, nasal aspirate | Nasal wash, nasal aspirate | | Read Result Time | 15 minutes | 15 minutes | | External Controls | Device includes an internal positive and negative procedural control | Device includes an internal positive and negative procedural control | ## Differences 1) The package inserts for the SAS Influenza A Test (K041441) and the SAS FluAlert A & B Test (K080380) have been updated to include detection of the A/Anhui/1/2013 H7N9 virus in the analytical sensitivity (LoD) section: {2} H7N9 A/Anhui/1/2013 - 2013759189 - 1.00x10⁸ EID₅₀/mL *This viral strain was obtained from the CDC with a known titer. SA Scientific, Ltd. did not verify this titer. 2) The package inserts for the SAS Influenza A Test (K041441) and the SAS FluAlert A & B Test (K080380) have been updated to include the following statement in the limitations section: Performance characteristics for detecting the 2009 H1N1 and 2013 H7N9 influenza viruses from human specimens have not been established. 3) The package insert for the SAS Influenza A Test (K041441) has been updated to include the following information in the analytical sensitivity (LoD) section: This test has been shown to detect the Flu A/California/04/09 (H1N1) and Flu A/Anhui/1/2013 viruses cultured from a positive human specimen; however, the performance characteristics of this test with clinical specimens that are positive for the 2009 H1N1 and 2013 H7N9 influenza virus have not been established. The SAS Influenza A Test can detect influenza A viruses, but cannot differentiate influenza subtypes. 4) The package insert for the SAS FluAlert A & B Test (K080380) has been updated to include the following information in the analytical sensitivity (LoD) section: This test has been shown to detect the Flu A/California/04/09 (H1N1) and Flu A/Anhui/1/2013 viruses cultured from a positive human specimen; however, the performance characteristics of this test with clinical specimens that are positive for the 2009 H1N1 and 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. 5) The package insert for the SAS FluAlert A & B Test (K080380) has been updated to include the following information in the cross reactivity section: Influenza A H7N9 A/Anhui/1/2013 - 2013759189 - 1.00x10⁹ EID₅₀/mL - Neg (for cross reactivity with the "B" portion of the SAS FluAlert A & B Test) ## 6. Design Control Activities Summary: 1) Analytical Reactivity Testing was conducted as described in section 3, Device Modifications. 2) Declaration of Conformity A "Declaration of Conformity" statement was submitted for the manufacturing facility and validation activities and signed by the Quality Assurance/Regulatory Affairs Specialist. The statements indicate that: a) The manufacturing facility, SA Scientific, Ltd. is in conformance with the design control requirements as specified in 21 CFR 820.30 and the records are available for review. b) To the best of my knowledge, the verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. {3} 4 In conclusion, based on the results of the analytical reactivity testing the modified labeling is truthful and accurate. The changes do not affect the performance of the tests and, therefore, they are substantially equivalent to the currently cleared tests. 7. A Truthful and Accurate Statement, a 510(k) Summary, and the Indications for Use Enclosure. The labeling for the modified subject devices has been reviewed to verify that the indication/intended uses for the devices are unaffected by the modification. In addition, the submitter's description of the particular modification and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. On this basis, I recommend that the devices are determined to be substantially equivalent to the previously cleared devices. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K132352](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K132352) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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