Cleared Traditional

K833180 - GONOCHEK-II

K833180 is an FDA 510(k) clearance for GONOCHEK-II, manufactured by E-Y Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K833180 · E-Y Laboratories, Inc. · Microbiology device
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Nov 1983
Decision
56d
Days
Class 1
Risk

K833180 is an FDA 510(k) clearance for the GONOCHEK-II. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by E-Y Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 56 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 E-Y Laboratories, Inc. devices

FDA 510(k) Submission Details - K833180

510(k) Number K833180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date November 14, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
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 K833180.
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
IDS RAPIDS NH SYSTEMS
K812048 · Carr-Scarborough Microbiologicals, Inc. · Aug 1981
NEISSERIA-KWIK
K811412 · Windsor Laboratories, Inc. · Jun 1981