Cleared Traditional

K922482 - MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/...

K922482 is the FDA 510(k) clearance for MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/... by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K922482 · Baxter Diagnostics, Inc. · Microbiology device
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Mar 1993
Decision
289d
Days
Class 2
Risk

K922482 is an FDA 510(k) clearance for the MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 12, 1993 after a review of 289 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 Diagnostics, Inc. devices

Submission Details

510(k) Number K922482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date March 12, 1993
Days to Decision 289 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
187d slower than avg
Panel avg: 102d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 37
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K922482.
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · Dade Behring, Inc. · Mar 2004
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
K981199 · Dade Microscan, Inc. · Nov 1998
SYNERGY SCREEN TEST, MODIFICATION
K921977 · Baxter Healthcare Corp · Oct 1993
WALKAWAY TM 40
K911400 · Baxter Healthcare Corp · Nov 1991
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
AUTOSCEPTOR
K896447 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990