Cleared Traditional

K852266 - ABBOTT STREP A P.S.D.

K852266 is an FDA 510(k) clearance for ABBOTT STREP A P.S.D., manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K852266 · Abbott Laboratories · Microbiology device
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Dec 1985
Decision
191d
Days
Class 1
Risk

K852266 is an FDA 510(k) clearance for the ABBOTT STREP A P.S.D.. 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 December 5, 1985 after a review of 191 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K852266

510(k) Number K852266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1985
Decision Date December 05, 1985
Days to Decision 191 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
89d slower than avg
Panel avg: 102d · This submission: 191d
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 81
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K852266.
DIFCO STREP A LATEX TEST
K854978 · Difco Laboratories, Inc. · Mar 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · Oxoid U.S.A., Inc. · Mar 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447 · American Micro Scan · Jan 1986
PHADIRECT STREP A TEST
K854150 · Pharmacia, Inc. · Oct 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · Marion Laboratories, Inc. · Aug 1985
QUIDEL QUEST STREP GROUP A TEST
K852806 · Quidel Corp. · Jul 1985