510(k) · Cleared
ClearedSas Flualert a & B, Sas Influenza a Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sa Scientific, Ltd. · GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Cleared on Aug 22, 2013 as substantially equivalent to K041441 (Sa Scientific, Inc., 2004) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Aug 22, 2013
- Review
- 24 days
- Class
- Class I
- Product code
- GNX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K991633 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK991633 Quickvue Influenza a/B TestQuidel Corp. · 1999
- 3 generations backK021649 Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab…Binax, Inc. · 2002
- 2 generations backK041441 Sas Influenza a TestSa Scientific, Inc. · 2004
- 1 generation backK080380 Sas Influenza a & B TestSa Scientific, Inc. · 2009
- This deviceK132352 Sas Flualert a & B, Sas Influenza a TestSa Scientific, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991633 | Quickvue Influenza a/B Test | Quidel Corp. | 1999 | — |
| −3 | K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen… | Binax, Inc. | 2002 | — |
| −2 | K041441 | Sas Influenza a Test | Sa Scientific, Inc. | 2004 | — |
| −1 | K080380 | Sas Influenza a & B Test | Sa Scientific, Inc. | 2009 | — |
| 0 (this device) | K132352 | Sas Flualert a & B, Sas Influenza a Test | Sa Scientific, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GNX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041441 | Sas Influenza a TestSummary page 1510(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 CER 807.92… | 2004 |
| * | K080380 | Sas Influenza a & B TestSummary page 4…23 510(k) SUMMARY SASTM FluAlert A & B Test K080380 This 5 10(k) summary of safety and effectiveness submission is in accordance with the requirements of SMDA 1990 and 21 CFR 807.9… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K041441.
How does its category compare?
All GNX devicesGNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GNX
6in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GNX
27in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GNX
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNX
93in 2025
MAUDE reports naming product code GNX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 4 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 6 | 27 | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 93 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (189 words)
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 far treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.
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 isnot 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132352 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132352: Sas Flualert a & B, Sas Influenza a Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132352
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026