510(k) · Cleared
ClearedBiosign Strep a - Direct Strep a Antigen Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on Jul 7, 1997 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 7, 1997
- Review
- 88 days
- Class
- Class I
- Product code
- GTY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK971349 Biosign Strep a - Direct Strep a Antigen TestPrinceton BioMeditech Corp. · 1997
- Descendant · cites it directly · 3 of its ownK040708 Status First Strep aPrinceton BioMeditech Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK133343 Wondfo Rapid Strep a TestGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK260342 AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK212623 Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC · 2022
Most influential descendants
Showing 4 of 4 · See all- K040708Status First Strep aPrinceton BioMeditech Corp. · 2004 · cites it directly3descendants
- K133343Wondfo Rapid Strep a TestGuangzhou Wondfo Biotech Co., Ltd. · 2014 · 2 generations on2descendants
- K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd. · 2026 · 3 generations on0descendants
- K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971349 | Biosign Strep a - Direct Strep a Antigen Test | Princeton BioMeditech Corp. | 1997 | — |
| +1 | K040708 | Status First Strep a | Princeton BioMeditech Corp. | 2004 | — |
| +2 | K133343 | Wondfo Rapid Strep a Test | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +3 | K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026 | — |
| +3 | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | Healgen Scientific,, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GTY? 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 GTY device
- #1 K260342 AllTest Strep A Rapid Testscore 11.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040708 | Status First Strep a | 2004 | 3 |
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?
- Of its descendants, K040708 (Princeton BioMeditech Corp., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GTY devicesGTY Antigens, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GTY
Too few GTY 510(k)s in any year since 2007 to give a median.
Recalls per year · GTY
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTY
94in 2025
MAUDE reports naming product code GTY, 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 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 4 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 37 |
| 2022 | 1 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 1 | — | 0 | 94 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971349: Biosign Strep a - Direct Strep a Antigen Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971349
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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