Cleared Special

K120609 - VITROS CHEMISTRY PRODUCTS DHDL SLIDES

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

K120609 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K120609

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.

LBS Device Classification - Class 1, General Controls

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 69
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
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
K132711 · Carolina Liquid Chemistries Corp. · May 2014
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516 · Liposcience, Inc. · Sep 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
K103747 · Elitechgroup Seppim S.A.S. · Aug 2011
EASYRA HDL REAGENT
K111036 · Medica Corporation · Jul 2011
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
K100550 · Polymedco, Inc. · Sep 2010