Cleared Special

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (K012789) - FDA 510(k) Clearance

Class I Chemistry device.

K012789 · Morax · Chemistry device
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Jan 2002
Decision
150d
Days
Class 1
Risk

K012789 is an FDA 510(k) clearance for the MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 150 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Morax devices

Submission Details

510(k) Number K012789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2001
Decision Date January 17, 2002
Days to Decision 150 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JHO Electrophoretic Separation, Lipoproteins
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 - JHO Electrophoretic Separation, Lipoproteins

All 25
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K012789.
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · Helena Laboratories · Aug 2002
SPIFE 2000/3000 LIPOPROTEIN
K013466 · Helena Laboratories · Dec 2001
SPIFE CHOLESTEROL PROFILE KIT
K000603 · Helena Laboratories · Apr 2000
REP CHOLESTEROL PROFILE KIT
K992971 · Helena Laboratories · Oct 1999
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · Helena Laboratories · May 1998
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · Helena Laboratories · Jan 1997