Cleared Traditional

K972180 - DRIED GRAM-NEGATIVE MIC/COMBO PANELS

K972180 is the FDA 510(k) clearance for DRIED GRAM-NEGATIVE MIC/COMBO PANELS by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K972180 · Dade Microscan, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
52d
Days
Class 2
Risk

K972180 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 52 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 Microscan, Inc. devices

Submission Details

510(k) Number K972180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1997
Decision Date August 01, 1997
Days to Decision 52 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 102d · This submission: 52d
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 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K972180.
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
K972688 · Dade Microscan, Inc. · Sep 1997
PASCO MIC AND MIC/ID PANELS
K972567 · Pasco Laboratories, Inc. · Aug 1997
PASCO MIC AND MIC/ID PANELS
K971951 · Pasco Laboratories, Inc. · Aug 1997
ETEST FOR LEVOFLOXACIN
K971697 · Ab Biodisk · Jul 1997
ETEST FOR CEFTAZIDIME
K971694 · Ab Biodisk · Jun 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · Dade Microscan, Inc. · May 1997