Cleared Special

K033610 - HDL-CHOLESTEROL PLUS 2ND GENERATION

K033610 is an FDA 510(k) clearance for HDL-CHOLESTEROL PLUS 2ND GENERATION, manufactured by Roche Diagnostics Corp.. The device is a Class 1 Chemistry device with product code LBS cleared through the Special 510(k) pathway after a 18-day FDA review.

K033610 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
18d
Days
Class 1
Risk

K033610 is an FDA 510(k) clearance for the 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 December 5, 2003 after a review of 18 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.

FDA 510(k) Submission Details - K033610

510(k) Number K033610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2003
Decision Date December 05, 2003
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 77
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K033610.
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
K042195 · Beckman Coulter, Inc. · Sep 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · Beckman Coulter, Inc. · Jun 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · Stanbio Laboratory · Mar 2004
PICCOLO HDL TEST SYSTEM
K023640 · Abaxis, Inc. · Jan 2003
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · Genzyme Corp. · Jul 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · Jas Diagnostics, Inc. · Jul 2002
K033610 · HDL-CHOLESTEROL PLUS 2ND GENERATION
Download PDF FDA Summary Roche Diagnostics Cor…