Cleared Traditional

K102700 - LIPID CONTROLS

Also marketed or referenced as:
MULTI- ANALYTE CONTROL MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

K102700 is an FDA 510(k) clearance for LIPID CONTROLS, manufactured by Alere, San Diego, Dba Biosite INcorporated, Dba IN. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K102700 · Alere, San Diego, Dba Biosite INcorporated, Dba IN · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K102700

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 89d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 672
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K102700.
MSC LIPID CONTROL
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K102700 · LIPID CONTROLS
Download PDF FDA Summary Alere, San Diego, Dba…