Cleared Traditional

K913456 - VISI-NEISSERIA

K913456 is an FDA 510(k) clearance for VISI-NEISSERIA, manufactured by Kev Connecticut Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSX cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K913456 · Kev Connecticut Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
67d
Days
Class 1
Risk

K913456 is an FDA 510(k) clearance for the VISI-NEISSERIA. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Kev Connecticut Diagnostics, Inc. (Danielson, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 67 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 - K913456

510(k) Number K913456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date October 11, 1991
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

JSX Device Classification - Class 1, General Controls

Product Code JSX Kit, Identification, Neisseria Gonorrhoeae
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 - JSX Kit, Identification, Neisseria Gonorrhoeae

All 11
Devices cleared under the same product code (JSX) and FDA review panel - the closest regulatory comparables to K913456.
GONOPOX TEST KIT
K960759 · Medtex Laboratories, Inc. · Sep 1996
NIZYME TEST KIT
K923566 · Remel Co. · Nov 1992
XACT NEISSERIA
K880511 · Austin Biological Laboratories · Aug 1988
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
K870117 · Pro-Lab, Inc. · Mar 1987
QUAD FERM +
K853544 · Analytical Products, Inc. · Sep 1985
PHADEBACK G.C. POSITIVE CONTROLS
K833307 · Pharmacia, Inc. · Dec 1983