Cleared Traditional

K942089 - MICRODILUTION/LORACARBEF PANELS

K942089 is the FDA 510(k) clearance for MICRODILUTION/LORACARBEF PANELS by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K942089 · Baxter Diagnostics, Inc. · Microbiology device
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Jan 1995
Decision
252d
Days
Class 2
Risk

K942089 is an FDA 510(k) clearance for the MICRODILUTION/LORACARBEF PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on January 9, 1995 after a review of 252 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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K942089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1994
Decision Date January 09, 1995
Days to Decision 252 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 102d · This submission: 252d
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 K942089.
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · Baxter Diagnostics, Inc. · Feb 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · Baxter Diagnostics, Inc. · Jan 1995
PASCO MIC AND MIC/ID PANELS
K946126 · Pasco Laboratories, Inc. · Jan 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · Baxter Diagnostics, Inc. · Jan 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K943510 · Baxter Diagnostics, Inc. · Dec 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · Baxter Diagnostics, Inc. · Nov 1994