Cleared Traditional

K010337 - LIPOPRINT SYSTEM, LDL SUBFRACTIONS

K010337 is an FDA 510(k) clearance for LIPOPRINT SYSTEM, manufactured by Quantimetrix Corp.. The device is a Class 1 Chemistry device with product code JHO cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K010337 · Quantimetrix Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
170d
Days
Class 1
Risk

K010337 is an FDA 510(k) clearance for the 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 July 25, 2001 after a review of 170 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. 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 Quantimetrix Corp. devices

FDA 510(k) Submission Details - K010337

510(k) Number K010337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2001
Decision Date July 25, 2001
Days to Decision 170 days
Submission Type Traditional
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
82d slower than avg
Panel avg: 88d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

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 22
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K010337.
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
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