Cleared Traditional

K896265 - QUIDEL GROUP B STREP TEST

K896265 is the FDA 510(k) clearance for QUIDEL GROUP B STREP TEST by Quidel Corp.. It is a Class 1 Microbiology device (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

Submission Details

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.

Device Classification

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 47
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K896265.
REDITEST STREP A TEST KIT
K903194 · Boehringer Mannheim Corp. · Aug 1990
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
CLEARVIEW STREP A
K893422 · Unipath , Ltd. · Jun 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · Armkel, LLC · Feb 1989