Cleared Traditional

K960759 - GONOPOX TEST KIT

K960759 is an FDA 510(k) clearance for GONOPOX TEST KIT, manufactured by Medtex Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSX cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K960759 · Medtex Laboratories, Inc. · Microbiology device
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Sep 1996
Decision
205d
Days
Class 1
Risk

K960759 is an FDA 510(k) clearance for the GONOPOX TEST KIT. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Medtex Laboratories, Inc. (Seattle, US). The FDA issued a Cleared decision on September 18, 1996 after a review of 205 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 Medtex Laboratories, Inc. devices

FDA 510(k) Submission Details - K960759

510(k) Number K960759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1996
Decision Date September 18, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 102d · This submission: 205d
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 10
Devices cleared under the same product code (JSX) and FDA review panel - the closest regulatory comparables to K960759.
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
NEISSERIA IDENTIFICATION DISCS
K830364 · Oxoid U.S.A., Inc. · Mar 1983