Cleared Traditional

K923566 - NIZYME TEST KIT

K923566 is the FDA 510(k) clearance for NIZYME TEST KIT by Remel Co.. It is a Class 1 Microbiology device (product code JSX) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K923566 · Remel Co. · Microbiology device
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Nov 1992
Decision
108d
Days
Class 1
Risk

K923566 is an FDA 510(k) clearance for the NIZYME TEST KIT. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 108 days - within the typical 510(k) review window.

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 Remel Co. devices

Submission Details

510(k) Number K923566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date November 02, 1992
Days to Decision 108 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
6d slower than avg
Panel avg: 102d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (JSX) and FDA review panel - the closest regulatory comparables to K923566.
XACT NEISSERIA
K880511 · Austin Biological Laboratories · Aug 1988
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
GONO-CELL
K782013 · Abbott Laboratories · Apr 1979
MICROCULT-GC CULTURE TEST
K781108 · Miles Laboratories, Inc. · Aug 1978