Cleared Traditional

K941459 - GRAM POSITIVE DRIED OVERNIGHT PANELS/LO...

K941459 is the FDA 510(k) clearance for GRAM POSITIVE DRIED OVERNIGHT PANELS/LO... by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K941459 · Baxter Diagnostics, Inc. · Microbiology device
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Feb 1995
Decision
316d
Days
Class 2
Risk

K941459 is an FDA 510(k) clearance for the GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 316 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 K941459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date February 03, 1995
Days to Decision 316 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
214d slower than avg
Panel avg: 102d · This submission: 316d
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 K941459.
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
K945433 · Ab Biodisk · Mar 1995
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · Radiometer America, Inc. · Feb 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · 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
MICRODILUTION/LORACARBEF PANELS
K942089 · Baxter Diagnostics, Inc. · Jan 1995