Cleared Traditional

K952095 - VITEK GRAM POSITIVE IDENTIFICATION CARD...

K952095 is the FDA 510(k) clearance for VITEK GRAM POSITIVE IDENTIFICATION CARD... by Biomerieux Vitek, Inc.. It is a Class 1 Microbiology device (product code LQL) cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K952095 · Biomerieux Vitek, Inc. · Microbiology device
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Mar 1996
Decision
313d
Days
Class 1
Risk

K952095 is an FDA 510(k) clearance for the VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI). Classified as Gram Positive Identification Panel (product code LQL), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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. Elevated predicate reliance profile. 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K952095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1995
Decision Date March 12, 1996
Days to Decision 313 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 102d · This submission: 313d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQL Gram Positive Identification Panel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LQL Gram Positive Identification Panel

Devices cleared under the same product code (LQL) and FDA review panel - the closest regulatory comparables to K952095.
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
K961968 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1997
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
K925916 · Biomerieux Vitek, Inc. · Mar 1993
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · Vitek Systems, Inc. · Jul 1991
MODIFICATION TO API UNISCEPT 20GP
K901559 · Analytical Products, Inc. · Sep 1990