Cleared Traditional

K863252 - CHOLESTEROL PROCEDURE

K863252 is the FDA 510(k) clearance for CHOLESTEROL PROCEDURE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K863252 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
35d
Days
Class 1
Risk

K863252 is an FDA 510(k) clearance for the CHOLESTEROL PROCEDURE. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 35 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K863252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date September 29, 1986
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K863252.
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · Em Diagnostic Systems, Inc. · Mar 1987
PEG 6,000
K863103 · J. D. Assoc. · Jan 1987
CHOLESTEROL
K863927 · Tech-Co, Inc. · Nov 1986
CHOLESTEROL-E (TOTAL)
K863062 · J. D. Assoc. · Sep 1986
CHOLESTEROL-E (FREE)
K863064 · J. D. Assoc. · Sep 1986
CHOLESTEROL-E FAST (TOTAL)
K863063 · J. D. Assoc. · Sep 1986