Cleared Traditional

CHOLESTEROL-E (FREE) (K863064) - FDA 510(k) Clearance

Class I Chemistry device.

K863064 · J. D. Assoc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
30d
Days
Class 1
Risk

K863064 is an FDA 510(k) clearance for the CHOLESTEROL-E (FREE). Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 11, 1986 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry 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 J. D. Assoc. devices

Submission Details

510(k) Number K863064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date September 11, 1986
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 58
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K863064.
CHOLESTEROL REAGENT
K872295 · Sigma Diagnostics, Inc. · Jul 1987
HDL CHOLESTEROL REAGENT
K872575 · Sigma Chemical Co. · Jul 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · Em Diagnostic Systems, Inc. · Mar 1987
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707 · Em Diagnostic Systems, Inc. · Aug 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · Eastman Kodak Company · Jan 1986