Cleared Traditional

GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K894146) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894146 · Baxter Healthcare Corp · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
83d
Days
Class 2
Risk

K894146 is an FDA 510(k) clearance for the GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 83 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K894146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date September 05, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 102d · This submission: 83d
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 121
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K894146.
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · Baxter Healthcare Corp · Dec 1992
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K893977 · Baxter Healthcare Corp · Aug 1989
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
K883800 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988