Cleared Special

K012286 - MODIFICATION TO:COBAS INTEGRA HDL-CHOLE...

K012286 is the FDA 510(k) clearance for MODIFICATION TO:COBAS INTEGRA HDL-CHOLE... by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code LBS) cleared through the Special 510(k) pathway after a 19-day FDA review.

K012286 · Roche Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2001
Decision
19d
Days
Class 1
Risk

K012286 is an FDA 510(k) clearance for the MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 8, 2001 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K012286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date August 08, 2001
Days to Decision 19 days
Submission Type Special
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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 38
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K012286.
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc. · Feb 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032 · Olympus America, Inc. · Feb 2002
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · Randox Laboratories, Ltd. · Jul 1998
HDL
K981580 · Abbott Laboratories · Jun 1998