Cleared Traditional

K952095 - VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)

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

K952095 · Biomerieux Vitek, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K952095

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.

LQL Device Classification - Class 1, General Controls

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

All 7
Devices cleared under the same product code (LQL) and FDA review panel - the closest regulatory comparables to K952095.
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · Accumed Intl., Inc. · Jan 1998
RAPID GRAM-POSITIVE ID SYSTEM
K961730 · Becton Dickinson Microbiology Systems · Feb 1997
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