510(k) · Cleared
ClearedWondfo Rapid Strep a Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on Jan 31, 2014 as substantially equivalent to K040708 (Princeton BioMeditech Corp., 2004) after a 93-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 93 days
- Class
- Class I
- Product code
- GTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971349 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971349 Biosign Strep a - Direct Strep a Antigen TestPrinceton BioMeditech Corp. · 1997
- 1 generation backK040708 Status First Strep aPrinceton BioMeditech Corp. · 2004
- This deviceK133343 Wondfo Rapid Strep a TestGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK260342 AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK212623 Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC · 2022
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 | K971349 | Biosign Strep a - Direct Strep a Antigen Test | Princeton BioMeditech Corp. | 1997 | — |
| −1 | K040708 | Status First Strep a | Princeton BioMeditech Corp. | 2004 | — |
| 0 (this device) | K133343 | Wondfo Rapid Strep a Test | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +1 | K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K040708 | Status First Strep aSummary page 1…pp. serological 83 Microbiology reagents ____________ 5. Predicate Devices: K040708 Status First Strep A Princeton Biomnedtech Co. 6. Intended Use/Indications for Use The Wondfo Strep, A Rap… | 2004 |
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 17 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K260342 (Hangzhou AllTest Biotech Co., Ltd., 2026) has gone furthest, with 0 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. 2014, 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 Wondfo Strep A Rapid Test is a chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens from symptomatic patients to aid in the diagnosis of Group A Streptococcal Infection. All negative test results should be confirmed by bacterial Culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use, only.
For in vitro diagnostic use
For prescription Use only
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/K133343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133343: Wondfo Rapid Strep 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/K133343
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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