Cleared Traditional

K922458 - DRIED GRAM-NEGATIVE AND POSITIVE MIC/CO...

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

K922458 · Baxter Healthcare Corp · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 364
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
API UNISCEPT KB/TYPE 2 AND 3
K922926 · Analytical Products, Inc. · Oct 1992
THE E TEST, MODIFICATION
K913459 · Ab Biodisk · Sep 1991