Cleared Traditional

K925915 - VITEK RAPID CALL-GRAM NEGATIV IDENT CARD

K925915 is the FDA 510(k) clearance for VITEK RAPID CALL-GRAM NEGATIV IDENT CARD by Biomerieux Vitek, Inc.. It is a Class 1 Microbiology device (product code LQM) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K925915 · Biomerieux Vitek, Inc. · Microbiology device
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Mar 1993
Decision
120d
Days
Class 1
Risk

K925915 is an FDA 510(k) clearance for the VITEK RAPID CALL-GRAM NEGATIV IDENT CARD. Classified as Gram Negative Identification Panel (product code LQM), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 120 days - within the typical 510(k) review window.

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. 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K925915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date March 23, 1993
Days to Decision 120 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
18d slower than avg
Panel avg: 102d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQM Gram Negative 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 - LQM Gram Negative Identification Panel

Devices cleared under the same product code (LQM) and FDA review panel - the closest regulatory comparables to K925915.
ROCHE OXI/FERM II
K923313 · Roche Diagnostic Systems, Inc. · Apr 1993
SCEPTOR IDENTIFICATION SYSTEM
K912897 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429 · Vitek Systems, Inc. · Jun 1991
SENSITITRE AUTO ID PLATE AP80
K890057 · Radiometer America, Inc. · Jun 1989
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
K851528 · Pasco Laboratories, Inc. · Jul 1985