510(k) · Cleared

Cleared

Alere I Strep a

K141757510(k) TraditionalCleared Mar 31, 2015274-day reviewClass II21 CFR 866.2680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alere Scarborough, Inc. · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Cleared on Mar 31, 2015 as substantially equivalent to DEN140005 (Quidel Corporation, 2014) after a 274-day review. Its family tree reaches back 1 generation to 2014. 8 later devices descend from it.

Decided: Mar 31, 2015
Review: 274 days
Class: Class II
Product code: PGX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN140005 (2014). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
This deviceK141757 Alere I Strep aAlere Scarborough, Inc. · 2015
Descendant · cites it directly · 4 of its ownK151690 Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015
Descendant · cites it directly · 3 of its ownK173653 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control…Alere Scarborough, Inc. · 2018
Descendant · 2 generations on · 3 of its ownK173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i…Alere Scarborough, Inc. · 2018
Descendant · 2 generations on · 2 of its ownK220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. · 2022
Descendant · 3 generations on · 1 of its ownK232775 ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2023 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015high 2 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all

K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015 · cites it directly4descendants
K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc. · 2018 · cites it directly3descendants
K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. · 2018 · 2 generations on3descendants
K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. · 2022 · 2 generations on2descendants
K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2023 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN140005	Lyra Direct Strep Assay	Quidel Corporation	2014	—
0 (this device)	K141757	Alere I Strep a	Alere Scarborough, Inc.	2015	—
+1	K151690	Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	Alere Scarborough, Inc.	2015	—
+1	K173653	Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit	Alere Scarborough, Inc.	2018	—
+2	K173932	Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2	Alere Scarborough, Inc.	2018	—
+2	K220801	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2	Abbott Diagnostics Scarborough, Inc.	2022	—
+3	K232775	ID NOW Influenza A & B 2	Abbott Diagnostics Scarborough, Inc.	2023	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2018	2	0
2019	2	0
2022	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K141757, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	DEN140005	Lyra Direct Strep Assay 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.	Quidel Corporation	2014	—

Also cleared against DEN140005: 5 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151690	Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	Alere Scarborough, Inc.	2015	4
K173653	Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit	Alere Scarborough, Inc.	2018	3

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?

Its one ancestor has no recall.
Of its descendants, K151690 (Alere Scarborough, Inc., 2015) has gone furthest, with 4 descendants of its own.
5 other devices also cite its predicate DEN140005.

How does its category compare?

All PGX devices

PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · PGX

1in 2020

2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGX

85in 2015

2007high 85 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PGX

2in 2023

2007high 2 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PGX

1in 2022

2007high 2 (2019) · low 0 (2007)2025

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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141757: Alere I Strep a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141757

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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