Cleared Traditional

ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL (K864752) - FDA 510(k) Clearance

Class I Microbiology device.

K864752 · Abbott Laboratories · Microbiology device
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Feb 1987
Decision
83d
Days
Class 1
Risk

K864752 is an FDA 510(k) clearance for the ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 26, 1987 after a review of 83 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 Abbott Laboratories devices

Submission Details

510(k) Number K864752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date February 26, 1987
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTY Antigens, 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 - GTY Antigens, All Groups, Streptococcus Spp.

All 12
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K864752.
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PHADEBACT CSF POSITIVE CONTROLS
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PHADEBACT STREP POSITIVE CONTROLS
K832248 · Pharmacia, Inc. · Sep 1983
BBL DIRECTIGEN TEST KIT
K812808 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981