Cleared Traditional

K910537 - VISI-STREP

K910537 is an FDA 510(k) clearance for VISI-STREP, manufactured by Kev Connecticut Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LQL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K910537 · Kev Connecticut Diagnostics, Inc. · Microbiology device
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Apr 1991
Decision
63d
Days
Class 1
Risk

K910537 is an FDA 510(k) clearance for the VISI-STREP. Classified as Gram Positive Identification Panel (product code LQL), Class I - General Controls.

Submitted by Kev Connecticut Diagnostics, Inc. (Danielson, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kev Connecticut Diagnostics, Inc. devices

FDA 510(k) Submission Details - K910537

510(k) Number K910537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date April 12, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
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 8
Devices cleared under the same product code (LQL) and FDA review panel - the closest regulatory comparables to K910537.
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
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