Cleared Traditional

K884831 - ANAEROBIC MIC PANEL

K884831 is an FDA 510(k) clearance for ANAEROBIC 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 129-day FDA review.

K884831 · Microtech Medical Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
129d
Days
Class 2
Risk

K884831 is an FDA 510(k) clearance for the ANAEROBIC 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 March 27, 1989 after a review of 129 days - within the typical 510(k) review window.

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 - K884831

510(k) Number K884831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date March 27, 1989
Days to Decision 129 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 102d · This submission: 129d
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 K884831.
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K894146 · Baxter Healthcare Corp · Sep 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K893977 · Baxter Healthcare Corp · Aug 1989
MODIFICATION MIC/API UNISCEPT(R)
K884509 · Analytical Products, Inc. · Nov 1988
MODIFICATION MICRO-MIC
K884510 · Analytical Products, Inc. · Nov 1988
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988