Cleared Traditional

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (K864159) - FDA 510(k) Clearance

Class I Chemistry device.

K864159 · Chem-Elec, Inc. · Chemistry device
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Jun 1988
Decision
596d
Days
Class 1
Risk

K864159 is an FDA 510(k) clearance for the SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Chem-Elec, Inc. (North Webster, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 596 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Chem-Elec, Inc. devices

Submission Details

510(k) Number K864159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date June 10, 1988
Days to Decision 596 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
508d slower than avg
Panel avg: 88d · This submission: 596d
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 229
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K864159.
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K180504 · ACON Laboratories, Inc. · Mar 2018