510(k) · Cleared
ClearedHealgen Strep A Rapid Test Strip (Throat Swab)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on Mar 16, 2022 as substantially equivalent to K133343 (Guangzhou Wondfo Biotech Co., Ltd., 2014) after a 210-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 16, 2022
- Review
- 210 days
- Class
- Class I
- Product code
- GTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971349 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK971349 Biosign Strep a - Direct Strep a Antigen TestPrinceton BioMeditech Corp. · 1997
- 2 generations backK040708 Status First Strep aPrinceton BioMeditech Corp. · 2004
- 1 generation backK133343 Wondfo Rapid Strep a TestGuangzhou Wondfo Biotech Co., Ltd. · 2014
- This deviceK212623 Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971349 | Biosign Strep a - Direct Strep a Antigen Test | Princeton BioMeditech Corp. | 1997 | — |
| −2 | K040708 | Status First Strep a | Princeton BioMeditech Corp. | 2004 | — |
| −1 | K133343 | Wondfo Rapid Strep a Test | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| 0 (this device) | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | Healgen Scientific,, LLC | 2022 | — |
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 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
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 |
|---|---|---|---|
| * | K133343 | Wondfo Rapid Strep a TestSummary page 4…R # Panel GTY 866.3740 streptococcus spp serological reagents Microbiology 5. Predicate Devices: K133343 Wondfo Strep A Rapid Test Guangzhou Wondfo Biotech Co., Ltd. 6. Intended Use/Indications for Use The Strep A Rapid Tes… | 2014 |
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 25 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K133343.
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. 2022, this device’s year, is highlighted.
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?
The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212623 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212623: Healgen Strep A Rapid Test Strip (Throat Swab).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212623
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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