Cleared Traditional

K896265 - QUIDEL GROUP B STREP TEST

K896265 is an FDA 510(k) clearance for QUIDEL GROUP B STREP 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 108-day FDA review.

K896265 · Quidel Corp. · Microbiology device
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Feb 1990
Decision
108d
Days
Class 1
Risk

K896265 is an FDA 510(k) clearance for the QUIDEL GROUP B STREP 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 February 16, 1990 after a review of 108 days - within the typical 510(k) review window.

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. 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 Quidel Corp. devices

FDA 510(k) Submission Details - K896265

510(k) Number K896265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1989
Decision Date February 16, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 102d · This submission: 108d
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 K896265.
REDITEST STREP A TEST KIT
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PATHO DX STREP D
K902038 · Diagnostic Products Corp. · May 1990
TESTPACK PLUS STREP A
K901274 · Abbott Laboratories · May 1990
VENTRESIGN STREP A TEST
K897083 · Ventrex Laboratories, Inc. · Jan 1990
CARDS O.S.(TM) STREP A
K896221 · Pacific Biotech, Inc. · Dec 1989
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103 · Gen-Probe, Inc. · Nov 1989