Cleared Traditional

K934484 - QUICKVUE IN-LINE ONE-STEP STREP A TEST

K934484 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 307-day FDA review.

K934484 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
307d
Days
Class 1
Risk

K934484 is an FDA 510(k) clearance for the QUICKVUE IN-LINE ONE-STEP STREP A TEST. 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 July 18, 1994 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Quidel Corp. devices

FDA 510(k) Submission Details - K934484

510(k) Number K934484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1993
Decision Date July 18, 1994
Days to Decision 307 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
205d slower than avg
Panel avg: 102d · This submission: 307d
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 K934484.
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
K934383 · Pro-Lab, Inc. · Jan 1995
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
K942093 · Medical Diagnostic Technologies, Inc. · Nov 1994
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
K932482 · Medix Biotech, Inc. · Jul 1994
STREP A NEGATIVE CONTROL
K924461 · Pacific Biotech, Inc. · Dec 1993
QUIKPAC STREP A TEST
K924007 · Syntron Bioresearch, Inc. · Apr 1993
TESTPACK PLUS STREP A
K922345 · Abbott Laboratories · Jul 1992