510(k) · Cleared
ClearedAlere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cleared on May 2, 2018 as substantially equivalent to K141757 (Alere Scarborough, Inc., 2015) after a 155-day review. Its family tree reaches back 2 generations to 2014. 3 later devices descend from it.
- Decided
- May 2, 2018
- Review
- 155 days
- Class
- Class II
- Product code
- PGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN140005 (2014). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
- 1 generation backK141757 Alere I Strep aAlere Scarborough, Inc. · 2015
- This deviceK173653 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control…Alere Scarborough, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK232775 ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW…Abbott Diagnostics Scarborough, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. · 2022 · cites it directly2descendants
- K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2023 · 2 generations on1descendant
- K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN140005 | Lyra Direct Strep Assay | Quidel Corporation | 2014 | — |
| −1 | K141757 | Alere I Strep a | Alere Scarborough, Inc. | 2015 | — |
| 0 (this device) | K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018 | — |
| +1 | K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | Abbott Diagnostics Scarborough, Inc. | 2022 | — |
| +2 | K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023 | 2 |
| +2 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 PGX? 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 PGX device
- #1 K260047 cobas Strep A Nucleic acid test for use on the…score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K141757 | Alere I Strep aSummary page 4…1 CFR 866.2680 – Streptococcus spp. Nucleic Acid-Based Assay CLASSIFICATION Class II PRODUCT CODES PGX, OOI PANEL Microbiology (83) PREDICATE DEVICE Alere i Strep A, K141757 DEVICE DESCRIPTION Alere™ i Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | 2022 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220801 (Abbott Diagnostics Scarborough, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K141757.
How does its category compare?
All PGX devicesPGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PGX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PGX
85in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGX
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGX
1in 2022
MAUDE reports naming product code PGX, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | 85 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Alere i Strep A 2 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173653: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173653
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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