Cleared Traditional

K954257 - QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)

K954257 is an FDA 510(k) clearance for QUICKVUE IN-LINE ONE STEP STREP A TEST ..., manufactured by Quidel Corp.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K954257 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
85d
Days
Class 1
Risk

K954257 is an FDA 510(k) clearance for the QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION). Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quidel Corp. devices

FDA 510(k) Submission Details - K954257

510(k) Number K954257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date October 20, 1995
Days to Decision 85 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTZ Antisera, All Groups, Streptococcus Spp.

All 86
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K954257.
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K935475 · Syntron Bioresearch, Inc. · Aug 1995
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
K935554 · Syntron Bioresearch, Inc. · Aug 1995