Cleared Special

K120609 - VITROS CHEMISTRY PRODUCTS DHDL SLIDES

K120609 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS DHDL SLIDES by Ortho-Clinical Diagnostics, Inc.. It is a Class 1 Chemistry device (product code LBS) cleared through the Special 510(k) pathway after a 191-day FDA review.

K120609 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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Sep 2012
Decision
191d
Days
Class 1
Risk

K120609 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS DHDL SLIDES. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 7, 2012 after a review of 191 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K120609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2012
Decision Date September 07, 2012
Days to Decision 191 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
103d slower than avg
Panel avg: 88d · This submission: 191d
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 39
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K120609.
Direct HDL Cholesterol (HDL)
K153435 · Randox Laboratories, Ltd. · Jan 2016
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