Cleared Traditional

K972524 - DRIED GRAM-POSITIVE MIC/COMBO PANELS

K972524 is the FDA 510(k) clearance for DRIED GRAM-POSITIVE MIC/COMBO PANELS by Dade Intl., Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K972524 · Dade Intl., Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
63d
Days
Class 2
Risk

K972524 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Intl., Inc. (West Sacramento, US). The FDA issued a Cleared decision on September 8, 1997 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Dade Intl., Inc. devices

Submission Details

510(k) Number K972524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date September 08, 1997
Days to Decision 63 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
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 361
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K972524.
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PASCO MIC AND MIC/ID PANELS
K972567 · Pasco Laboratories, Inc. · Aug 1997
PASCO MIC AND MIC/ID PANELS
K971951 · Pasco Laboratories, Inc. · Aug 1997