Cleared Traditional

K000568 - HDL CHOLESTEROL PLUS

K000568 is an FDA 510(k) clearance for HDL CHOLESTEROL PLUS, manufactured by Roche Diagnostics Corp.. The device is a Class 1 Chemistry device with product code LBT cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K000568 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
164d
Days
Class 1
Risk

K000568 is an FDA 510(k) clearance for the HDL CHOLESTEROL PLUS. Classified as Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (product code LBT), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 164 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K000568

510(k) Number K000568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date August 04, 2000
Days to Decision 164 days
Submission Type Traditional
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
76d slower than avg
Panel avg: 88d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

LBT Device Classification - Class 1, General Controls

Product Code LBT Electrophoresis, 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 - LBT Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl

Devices cleared under the same product code (LBT) and FDA review panel - the closest regulatory comparables to K000568.
HYDRAGEL 7,15,30, CHOL-HDL KIT
K972015 · Morax · Oct 1997
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
K904035 · Helena Laboratories · Nov 1990
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
K894366 · Helena Laboratories · Aug 1989
REP HDL ELECTROPHORESIS METHOD
K882368 · Helena Laboratories · Aug 1988
TITAN GEL HDL CHOLESTEROL KIT
K873547 · Helena Laboratories · Oct 1987
ELECTROPHORESIS REAGENT SET, HDL
K790791 · Gelman Sciences, Inc. · Jun 1979