Cleared Traditional

K945235 - DRIED GRAM-POSITIVE MIC/COMBO PANELS

K945235 is the FDA 510(k) clearance for DRIED GRAM-POSITIVE MIC/COMBO PANELS by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LTT) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K945235 · Baxter Diagnostics, Inc. · Microbiology device
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Mar 1995
Decision
131d
Days
Class 2
Risk

K945235 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 131 days - within the typical 510(k) review window.

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 Diagnostics, Inc. devices

Submission Details

510(k) Number K945235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date March 07, 1995
Days to Decision 131 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
29d slower than avg
Panel avg: 102d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
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 - LTT Panels, Test, Susceptibility, Antimicrobial

All 44
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K945235.
PASCO MIC AND MIC/ID PANELS
K973317 · Pasco Laboratories, Inc. · Nov 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · Dade Microscan, Inc. · Oct 1997
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · Baxter Diagnostics, Inc. · Apr 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · Baxter Diagnostics, Inc. · Feb 1995