Cleared Traditional

K910304 - RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA

K910304 is an FDA 510(k) clearance for RAPID CORYNE SYST/IDENTIF OF CORYNEFORM..., manufactured by Vitek Systems, Inc.. The device is a Class 1 Microbiology device with product code LQL cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K910304 · Vitek Systems, Inc. · Microbiology device
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Jul 1991
Decision
183d
Days
Class 1
Risk

K910304 is an FDA 510(k) clearance for the RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA. Classified as Gram Positive Identification Panel (product code LQL), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 183 days - an extended review cycle.

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 Vitek Systems, Inc. devices

FDA 510(k) Submission Details - K910304

510(k) Number K910304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1991
Decision Date July 26, 1991
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 102d · This submission: 183d
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 K910304.
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
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
K925916 · Biomerieux Vitek, Inc. · Mar 1993
MODIFICATION TO API UNISCEPT 20GP
K901559 · Analytical Products, Inc. · Sep 1990
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · American Micro Scan · Sep 1986