Cleared Traditional

K971072 - CHOLESTEROL REAGENT

K971072 is an FDA 510(k) clearance for CHOLESTEROL REAGENT, manufactured by Derma Media Lab., Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K971072 · Derma Media Lab., Inc. · Chemistry device
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Jun 1997
Decision
88d
Days
Class 1
Risk

K971072 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 88 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K971072

510(k) Number K971072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date June 20, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
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 176
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K971072.
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667 · Sigma Diagnostics, Inc. · Apr 1998
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · Roche Diagnostic Systems, Inc. · Dec 1997
CHOLESTEROL RAPID LIQUID REAGENT
K972853 · Reagents Applications, Inc. · Sep 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · Beckman Instruments, Inc. · Jun 1997
PARAMAX CHOLESTEROL REAGENT
K964660 · Dade Intl., Inc. · Jun 1997
CHOL OR CHOLESTEROL
K971345 · Carolina Liquid Chemistries Corp. · May 1997