Cleared Traditional

K162593 - HDL-Cholesterol Gen.4

K162593 is the FDA 510(k) clearance for HDL-Cholesterol Gen.4 by Roche Diagnostics Operations (Rdo). It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K162593 · Roche Diagnostics Operations (Rdo) · Chemistry device
Download Printable Device Report (PDF)
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Oct 2016
Decision
33d
Days
Class 1
Risk

K162593 is an FDA 510(k) clearance for the HDL-Cholesterol Gen.4. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on October 19, 2016 after a review of 33 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Operations (Rdo) devices

Submission Details

510(k) Number K162593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2016
Decision Date October 19, 2016
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
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 K162593.
Direct HDL Cholesterol (HDL)
K153435 · Randox Laboratories, Ltd. · Jan 2016
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