Cleared Traditional

K000568 - HDL CHOLESTEROL PLUS

K000568 is the FDA 510(k) clearance for HDL CHOLESTEROL PLUS by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (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

Submission Details

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.

Device Classification

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.
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