Cleared Traditional

K945235 - DRIED GRAM-POSITIVE MIC/COMBO PANELS

K945235 is an FDA 510(k) clearance for DRIED GRAM-POSITIVE MIC/COMBO PANELS, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K945235

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.

LTT Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K945235.
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K962150 · Dade Intl., Inc. · Aug 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · Accumed Intl., Inc. · Apr 1996
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · Baxter Diagnostics, Inc. · Apr 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · Baxter Diagnostics, Inc. · Feb 1995