Cleared Special

K013662 - MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

K013662 is an FDA 510(k) clearance for MODIFICATION TO LIPOPRINT SYSTEM, manufactured by Quantimetrix Corp.. The device is a Class 1 Chemistry device with product code JHO cleared through the Special 510(k) pathway after a 122-day FDA review.

K013662 · Quantimetrix Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
122d
Days
Class 1
Risk

K013662 is an FDA 510(k) clearance for the MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 122 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. 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 - K013662

510(k) Number K013662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date March 08, 2002
Days to Decision 122 days
Submission Type Special
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
34d slower than avg
Panel avg: 88d · This submission: 122d
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 K013662.
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
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · Morax · Jan 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
K013662 · MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
Download PDF FDA Summary Quantimetrix Corp.