Cleared Traditional

K863103 - PEG 6

K863103 is the FDA 510(k) clearance for PEG 6 by J. D. Assoc.. It is a Class 1 Chemistry device (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

Submission Details

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.

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 126
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K863103.
HDL CHOLESTEROL REAGENT
K872575 · Sigma Chemical Co. · Jul 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928 · Electro-Nucleonics Laboratories, Inc. · Apr 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · Em Diagnostic Systems, Inc. · Mar 1987
CHOLESTEROL
K863927 · Tech-Co, Inc. · Nov 1986
CHOLESTEROL PROCEDURE
K863252 · Data Medical Associates, Inc. · Sep 1986
CHOLESTEROL-E (TOTAL)
K863062 · J. D. Assoc. · Sep 1986