Cleared Dual Track

K173398 - Xpert Xpress Strep A (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K173398 · Cepheid · Microbiology device
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Apr 2018
Decision
177d
Days
Class 2
Risk

K173398 is an FDA 510(k) clearance for the Xpert Xpress Strep A. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 26, 2018 after a review of 177 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.

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Submission Details

510(k) Number K173398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2017
Decision Date April 26, 2018
Days to Decision 177 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics

Device Classification

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.