Cleared Traditional

K972182 - ABBOTT STREP A CONTROLS (FDA 510(k) Clearance)

Class I Microbiology device.

K972182 · Abbott Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
76d
Days
Class 1
Risk

K972182 is an FDA 510(k) clearance for the ABBOTT STREP A CONTROLS. Classified as Kit, Direct Antigen, Positive Control (product code MJZ), Class I - General Controls.

Submitted by Abbott Diagnostics (Abbott Park, US). The FDA issued a Cleared decision on August 13, 1997 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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.

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Submission Details

510(k) Number K972182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date August 13, 1997
Days to Decision 76 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 102d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJZ Kit, Direct Antigen, Positive Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.