Cleared Traditional

K922458 - DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS

K922458 is an FDA 510(k) clearance for DRIED GRAM-NEGATIVE AND POSITIVE MIC/CO..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K922458 · Baxter Healthcare Corp · Microbiology device
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Dec 1992
Decision
199d
Days
Class 2
Risk

K922458 is an FDA 510(k) clearance for the DRIED 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 December 11, 1992 after a review of 199 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 Healthcare Corp devices

FDA 510(k) Submission Details - K922458

510(k) Number K922458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1992
Decision Date December 11, 1992
Days to Decision 199 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
97d slower than avg
Panel avg: 102d · This submission: 199d
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 406
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K922458.
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · Baxter Diagnostics, Inc. · Mar 1993
SENSITITRE SUSCEPTIBILITY PLATES
K923045 · Radiometer America, Inc. · Mar 1993
CATION ADJUSTED MUELLER HINTON BROTH
K925644 · Pasco Laboratories, Inc. · Jan 1993
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
K923684 · Analytical Products, Inc. · Dec 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST
K924500 · Alamar Biosciences Laboratory, Inc. · Nov 1992
API UNISCEPT KB/TYPE 2 AND 3
K922926 · Analytical Products, Inc. · Oct 1992