Cleared Special

K012789 - MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

K012789 is an FDA 510(k) clearance for MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N..., manufactured by Morax. The device is a Class 1 Chemistry device with product code JHO cleared through the Special 510(k) pathway after a 150-day FDA review.

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.

FDA 510(k) Submission Details - K012789

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 89d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

JHO Device Classification - Class 1, General Controls

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
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · Sebia · Jul 2002
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · Quantimetrix Corp. · Mar 2002
SPIFE 2000/3000 LIPOPROTEIN
K013466 · Helena Laboratories · Dec 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · Quantimetrix Corp. · Jul 2001
SPIFE CHOLESTEROL PROFILE KIT
K000603 · Helena Laboratories · Apr 2000
K012789 · MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
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