Cleared Traditional

HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 (K990250) - FDA 510(k) Clearance

Class I Chemistry device.

K990250 · Morax · Chemistry device
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Jun 1999
Decision
143d
Days
Class 1
Risk

K990250 is an FDA 510(k) clearance for the HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KI.... Classified as Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (product code LBT), Class I - General Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on June 18, 1999 after a review of 143 days - within the typical 510(k) review window.

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 Morax devices

Submission Details

510(k) Number K990250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1999
Decision Date June 18, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
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 K990250.
HDL CHOLESTEROL PLUS
K000568 · Roche Diagnostics Corp. · Aug 2000
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