Cleared Traditional

K852998 - NEISSERIA - KWIK PLUS

K852998 is the FDA 510(k) clearance for NEISSERIA - KWIK PLUS by Micro-Bio-Logics. It is a Class 1 Microbiology device (product code JSX) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K852998 · Micro-Bio-Logics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
8d
Days
Class 1
Risk

K852998 is an FDA 510(k) clearance for the NEISSERIA - KWIK PLUS. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 8 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 Micro-Bio-Logics devices

Submission Details

510(k) Number K852998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date July 23, 1985
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 102d · This submission: 8d
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

All 7
Devices cleared under the same product code (JSX) and FDA review panel - the closest regulatory comparables to K852998.
NIZYME TEST KIT
K923566 · Remel Co. · Nov 1992
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