510(k) · Cleared
ClearedSas Influenza a & B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sa Scientific, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Jul 23, 2009 as substantially equivalent to K041441 (Sa Scientific, Inc., 2004) and 1 other predicate after a 526-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Jul 23, 2009
- Review
- 526 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991633 (1999). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK991633 Quickvue Influenza a/B TestQuidel Corp. · 1999
- 2 generations backK021649 Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab…Binax, Inc. · 2002
- 1 generation backK041441 Sas Influenza a TestSa Scientific, Inc. · 2004
- This deviceK080380 Sas Influenza a & B TestSa Scientific, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK132352 Sas Flualert a & B, Sas Influenza a TestSa Scientific, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132352Sas Flualert a & B, Sas Influenza a TestSa Scientific, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991633 | Quickvue Influenza a/B Test | Quidel Corp. | 1999 | — |
| −2 | K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen… | Binax, Inc. | 2002 | — |
| −1 | K041441 | Sas Influenza a Test | Sa Scientific, Inc. | 2004 | — |
| 0 (this device) | K080380 | Sas Influenza a & B Test | Sa Scientific, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 PSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 Test Our OCR of the scanned summary read K044141, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SAS Influenza A Test”. | 2004 |
| * | K041439 | Sas Influenza B TestSummary page 1…alence: Substantially equivalent to the SASTM individual devices-SASTM Influenza A Test (K044 141) and SASrm Influenza B Test (K04 1439), manufactured by SA Scientific, Ltd., San Antonio, TX. Device Description: The… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132352 | Sas Flualert a & B, Sas Influenza a Test | 2013 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K132352 (Sa Scientific, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041441.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080380: Sas Influenza a & B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080380
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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