Cleared Dual Track

K173653 - Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

K173653 is an FDA 510(k) clearance for Alere i Strep A 2, manufactured by Alere Scarborough, Inc.. The device is a Class 2 Microbiology device with product code PGX cleared through the Dual Track 510(k) pathway after a 155-day FDA review.

K173653 · Alere Scarborough, Inc. · Microbiology device
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May 2018
Decision
155d
Days
Class 2
Risk

K173653 is an FDA 510(k) clearance for the Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on May 2, 2018 after a review of 155 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2680 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alere Scarborough, Inc. devices

FDA 510(k) Submission Details - K173653

510(k) Number K173653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2017
Decision Date May 02, 2018
Days to Decision 155 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 102d · This submission: 155d
Pathway characteristics

PGX Device Classification - Class 2, Special Controls

Product Code PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2680
Definition An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

All 14
Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K173653.
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