Cleared Traditional

K102700 - LIPID CONTROLS (FDA 510(k) Clearance)

Also includes:
MULTI- ANALYTE CONTROL MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

Class I Chemistry device.

K102700 · Alere, San Diego, Dba Biosite INcorporated, Dba IN · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
92d
Days
Class 1
Risk

K102700 is an FDA 510(k) clearance for the LIPID CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Alere, San Diego, Dba Biosite INcorporated, Dba IN (San Diego, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Alere, San Diego, Dba Biosite INcorporated, Dba IN devices

Submission Details

510(k) Number K102700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date December 21, 2010
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.