Cleared Traditional

K072249 - EASYRA CHOLESTEROL REAGENT

Also marketed or referenced as:
EASYRA CALCIUM REAGENT REAGENT

K072249 is the FDA 510(k) clearance for EASYRA CHOLESTEROL REAGENT by Medica Corp.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K072249 · Medica Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
191d
Days
Class 1
Risk

K072249 is an FDA 510(k) clearance for the EASYRA CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Medica Corp. (Beverly, US). The FDA issued a Cleared decision on February 20, 2008 after a review of 191 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 Medica Corp. devices

Submission Details

510(k) Number K072249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date February 20, 2008
Days to Decision 191 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 88d · This submission: 191d
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 89
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K072249.
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COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · Roche Diagnostics Corp. · Jul 2003
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803 · Sigma Diagnostics, Inc. · Sep 1999