Cleared Traditional

K982469 - HICHEM CHOLESTEROL REAGENT KIT

K982469 is an FDA 510(k) clearance for HICHEM CHOLESTEROL REAGENT KIT, manufactured by Elan Pharma, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K982469 · Elan Pharma, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
35d
Days
Class 1
Risk

K982469 is an FDA 510(k) clearance for the HICHEM CHOLESTEROL REAGENT KIT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Elan Pharma, Inc. (Brea, US). The FDA issued a Cleared decision on August 19, 1998 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 Elan Pharma, Inc. devices

FDA 510(k) Submission Details - K982469

510(k) Number K982469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date August 19, 1998
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
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.

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 182
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K982469.
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