Cleared Traditional

K863103 - PEG 6,000

K863103 is an FDA 510(k) clearance for PEG 6, manufactured by J. D. Assoc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K863103 · J. D. Assoc. · Chemistry device
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Jan 1987
Decision
153d
Days
Class 1
Risk

K863103 is an FDA 510(k) clearance for the PEG 6,000. 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 January 13, 1987 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J. D. Assoc. devices

FDA 510(k) Submission Details - K863103

510(k) Number K863103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date January 13, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 186
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K863103.
CHOLESTEROL DETERMINATION
K871260 · Biochemical Trade, Inc. · Apr 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · Intersect Systems, Inc. · Mar 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · Em Diagnostic Systems, Inc. · Mar 1987
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K864081 · U. S. Diagnostics, Inc. · Dec 1986
CHOLESTEROL
K863927 · Tech-Co, Inc. · Nov 1986
CHOLESTEROL PROCEDURE
K863252 · Data Medical Associates, Inc. · Sep 1986