Cleared Traditional

K883999 - QUIDEL GROUP A STREP TEST

K883999 is an FDA 510(k) clearance for QUIDEL GROUP A 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 23-day FDA review.

K883999 · Quidel Corp. · Microbiology device
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Oct 1988
Decision
23d
Days
Class 1
Risk

K883999 is an FDA 510(k) clearance for the QUIDEL GROUP A 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 October 12, 1988 after a review of 23 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 - K883999

510(k) Number K883999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1988
Decision Date October 12, 1988
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
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 K883999.
LEECO VIS-DISK STREP-A (EIA)
K894122 · Leeco Diagnostics, Inc. · Aug 1989
CLEARVIEW STREP A
K893422 · Unipath , Ltd. · Jun 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · Armkel, LLC · Feb 1989
KODAK SURECELL STREP A TEST KIT
K881457 · Eastman Kodak Company · Apr 1988
V-TREND STREP A TEST
K880483 · Texas Immunology, Inc. · Apr 1988
TARGET STREP A
K880460 · V-Tech, Inc. · Mar 1988