510(k) · Cleared
ClearedSas Influenza a 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 22, 2004 as substantially equivalent to K021649 (Binax, Inc., 2002) after a 51-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991633 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991633 Quickvue Influenza a/B TestQuidel Corp. · 1999
- 1 generation backK021649 Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab…Binax, Inc. · 2002
- This deviceK041441 Sas Influenza a TestSa Scientific, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK080380 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991633 | Quickvue Influenza a/B Test | Quidel Corp. | 1999 | — |
| −1 | K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen… | Binax, Inc. | 2002 | — |
| 0 (this device) | K041441 | Sas Influenza a Test | Sa Scientific, Inc. | 2004 | — |
| +1 | K080380 | Sas Influenza a & B Test | Sa Scientific, Inc. | 2009 | — |
| +1 | K132352 | Sas Flualert a & B, Sas Influenza a Test | Sa Scientific, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackSummary page 1…n: 21 CFR Part 866.3330 Regulatory Class: Class I Product Code: GNX Substantial Equivalence: Binax TM NOW® Flu A Test (K021649) manufactured by BinaxTM Inc., Portland, Maine. Device Description: The SASTM Influe… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080380 (Sa Scientific, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K021649.
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.
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 Influenza A Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type A antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type B or C viral antigen. The test is for professional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041441: Sas Influenza a Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041441
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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