Cleared Traditional

K941317 - DRIED GRAM NEGATIVE/CEFMETAZOLE

K941317 is the FDA 510(k) clearance for DRIED GRAM NEGATIVE/CEFMETAZOLE by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K941317 · Baxter Diagnostics, Inc. · Microbiology device
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Jan 1995
Decision
319d
Days
Class 2
Risk

K941317 is an FDA 510(k) clearance for the DRIED GRAM NEGATIVE/CEFMETAZOLE. 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 31, 1995 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K941317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date January 31, 1995
Days to Decision 319 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
217d slower than avg
Panel avg: 102d · This submission: 319d
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 K941317.
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · Radiometer America, Inc. · Feb 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · Baxter Diagnostics, Inc. · Feb 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · Baxter Diagnostics, Inc. · Feb 1995
PASCO MIC AND MIC/ID PANELS
K946126 · Pasco Laboratories, Inc. · Jan 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · Baxter Diagnostics, Inc. · Jan 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · Baxter Diagnostics, Inc. · Jan 1995