# K141757: Alere I Strep a

- Pathway: 510(k) (Traditional)
- Applicant: Alere Scarborough, Inc.
- Decided: Mar 31, 2015 after 274 days
- Product code: PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 866.2680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN140005 (2014). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140005: Lyra Direct Strep Assay, Quidel Corporation (2014). Our reading of the summary gave K133883, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140005, Lyra Direct Strep Assay (Quidel Corporation), granted Apr 16, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K151690: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (2015), 4 descendants of its own
- K173653: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (2018), 3 descendants of its own
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (2018), 3 descendants of its own
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (2022), 2 descendants of its own
- K232775: ID NOW Influenza A & B 2 (2023), 1 descendant of its own

## Indications for use
Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections. 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.

Source page: https://510kreport.com/device/K141757
Methodology: https://510kreport.com/methodology