510(k) · Cleared
ClearedSas Influenza 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 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, 1 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 deviceK041439 Sas Influenza B TestSa Scientific, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK080380 Sas Influenza a & B TestSa Scientific, Inc. · 2009
- Descendant · 2 generations on · 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) | K041439 | Sas Influenza B Test | Sa Scientific, Inc. | 2004 | — |
| +1 | K080380 | Sas Influenza a & B Test | Sa Scientific, Inc. | 2009 | — |
| +2 | 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…on: 21 CFR Part 866.3330 Regulatory Class: Class I Product Code: GNX Substantial Equivalence: BinaxTM NOW® Flu B Test (K021649) manufactured by Binax TM Inc., Portland, Maine. Device Description: The SASr" Influ… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080380 | Sas Influenza a & B Test | 2009 | 1 |
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?
SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen. The test is for professional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041439: Sas Influenza 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/K041439
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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