Cleared Special

K013662 - MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (FDA 510(k) Clearance)

Class I Chemistry device.

K013662 · Quantimetrix Corp. · Chemistry device
Download Printable Device Report (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.

View all Quantimetrix Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 88d · This submission: 122d
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.