510(k) · Cleared
Recalled · 2011Acon Strep a Rapid Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on Jul 14, 2003 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Jul 14, 2003
- Review
- 34 days
- Class
- Class I
- Product code
- GTY
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2011 | Not classified | Z-1074-2012 | Process change control | Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry… |
| Jan 12, 2011 | Not classified | Z-1395-2011 | Pending | The recall was initiated after the Investigation of customer-reported complaints, testing of market retention and returned product, It was determined that this lot of product has demonstrated an elevated Incidence of non-specific binding… |
No ancestor or descendant has a Class I recall.
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?
The ACON Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031784: Acon Strep a Rapid Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031784
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026