Cleared Traditional

K925916 - VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD

K925916 is an FDA 510(k) clearance for VITEK RAPID CALL-GRAM POSITIVE IDENTIFI..., manufactured by Biomerieux Vitek, Inc.. The device is a Class 1 Chemistry device with product code LQL cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K925916 · Biomerieux Vitek, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
120d
Days
Class 1
Risk

K925916 is an FDA 510(k) clearance for the VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD. 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 23, 1993 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K925916

510(k) Number K925916 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 Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
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 K925916.
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 GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · Biomerieux Vitek, Inc. · Mar 1996
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · Vitek Systems, Inc. · Jul 1991
MODIFICATION TO API UNISCEPT 20GP
K901559 · Analytical Products, Inc. · Sep 1990
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · American Micro Scan · Sep 1986