# K031784: Acon Strep a Rapid Test Device

- Pathway: 510(k) (Special)
- Applicant: ACON Laboratories, Inc.
- Decided: Jul 14, 2003 after 34 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 1, 2011 · Not classified · Z-1074-2012: 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 tha
- Jan 12, 2011 · Not classified · Z-1395-2011: 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 eleva

## Indications for use
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.

Source page: https://510kreport.com/device/K031784
Methodology: https://510kreport.com/methodology