Cleared Traditional

K010337 - LIPOPRINT SYSTEM

K010337 is the FDA 510(k) clearance for LIPOPRINT SYSTEM by Quantimetrix Corp.. It is a Class 1 Chemistry device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 88d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

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 18
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K010337.
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