Cleared Traditional

K073497 - HDL CHOLESTEROL REAGENT

K073497 is the FDA 510(k) clearance for HDL CHOLESTEROL REAGENT by Medica Corp.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K073497 · Medica Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
123d
Days
Class 1
Risk

K073497 is an FDA 510(k) clearance for the HDL CHOLESTEROL REAGENT, MODEL 10211. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 14, 2008 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 K073497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2007
Decision Date April 14, 2008
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 39
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K073497.
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609 · Ortho-Clinical Diagnostics, Inc. · Sep 2012
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · Beckman Coulter, Inc. · May 2010
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · Wako Chemicals USA, Inc. · Jul 2008
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · Dade Behring, Inc. · Dec 2005
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928 · Diagnostic Chemicals , Ltd. · Nov 2004