Cleared Traditional

K941317 - DRIED GRAM NEGATIVE/CEFMETAZOLE

K941317 is an FDA 510(k) clearance for DRIED GRAM NEGATIVE/CEFMETAZOLE, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K941317

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.

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 404
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
BBL CRYSTAL MRSA ID SYSTEM
K941997 · Becton Dickinson Microbiology Systems · Jan 1995
PASCO MIC AND MIC/ID PANELS
K946126 · Pasco Laboratories, Inc. · Jan 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · Baxter Diagnostics, Inc. · Jan 1995