Cleared Traditional

K853544 - QUAD FERM +

K853544 is the FDA 510(k) clearance for QUAD FERM + by Analytical Products, Inc.. It is a Class 1 Microbiology device (product code JSX) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K853544 · Analytical Products, Inc. · Microbiology device
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Sep 1985
Decision
10d
Days
Class 1
Risk

K853544 is an FDA 510(k) clearance for the QUAD FERM +. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 10 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 Analytical Products, Inc. devices

Submission Details

510(k) Number K853544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date September 05, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
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 K853544.
NIZYME TEST KIT
K923566 · Remel Co. · Nov 1992
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