Cleared Traditional

K901598 - FASTIDIOUS MIC PANEL

K901598 is an FDA 510(k) clearance for FASTIDIOUS MIC PANEL, manufactured by Microtech Medical Systems, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K901598 · Microtech Medical Systems, Inc. · Microbiology device
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Nov 1990
Decision
217d
Days
Class 2
Risk

K901598 is an FDA 510(k) clearance for the FASTIDIOUS MIC PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Microtech Medical Systems, Inc. (Aurora, US). The FDA issued a Cleared decision on November 8, 1990 after a review of 217 days - an extended review 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: 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 Microtech Medical Systems, Inc. devices

FDA 510(k) Submission Details - K901598

510(k) Number K901598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1990
Decision Date November 08, 1990
Days to Decision 217 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 102d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 408
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K901598.
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K905853 · Alamar Biosciences Laboratory, Inc. · Feb 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
K904523 · Alamar Biosciences Laboratory, Inc. · Dec 1990
EF SYNERGY QUAD
K903589 · Remel Co. · Nov 1990
PASCO MIC AND MIC/ID MODIFIED
K902739 · Pasco Laboratories, Inc. · Jul 1990
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K896566 · Medical Specialties, Inc. · Feb 1990