Cleared Traditional

ABBOTT LABORATORIES STREP A EIA (K823569) - FDA 510(k) Clearance

Class I Chemistry device.

K823569 · Abbott Laboratories · Chemistry device
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Mar 1983
Decision
88d
Days
Class 1
Risk

K823569 is an FDA 510(k) clearance for the ABBOTT LABORATORIES STREP A EIA. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.3740 - the FDA in vitro diagnostics and chemistry 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 Abbott Laboratories devices

Submission Details

510(k) Number K823569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1982
Decision Date March 01, 1983
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
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 28
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K823569.
DETECT GROUP A STREP TEST
K834582 · Difco Laboratories, Inc. · Apr 1984
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
PHADEBACT STREP F TEST
K830445 · Pharmacia, Inc. · Apr 1983
PHADEBACT STREP D TEST
K800159 · Pharmacia, Inc. · Apr 1980