Cleared Traditional

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (K904035) - FDA 510(k) Clearance

Class I Chemistry device.

K904035 · Helena Laboratories · Chemistry device
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Nov 1990
Decision
70d
Days
Class 1
Risk

K904035 is an FDA 510(k) clearance for the REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM. Classified as Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (product code LBT), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 70 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 Helena Laboratories devices

Submission Details

510(k) Number K904035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1990
Decision Date November 09, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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

All 7
Devices cleared under the same product code (LBT) and FDA review panel - the closest regulatory comparables to K904035.
HDL CHOLESTEROL PLUS
K000568 · Roche Diagnostics Corp. · Aug 2000
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