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Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification Materials

by Alere, San Diego, Dba Biosite INcorporated, Dba IN

510(k) K102700

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102700 Date21 Dec 2010ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0122-2016 FDA Class III initiated 27 Aug 2015

    Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.

  • 2 recalls, same reason

    • Terminated Z-0747-2013 FDA Class III initiated 22 Oct 2012
    • Terminated Z-0746-2013 FDA Class III initiated 22 Oct 2012

    Out of range (increased) HDL Cholesterol results.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JJY
Models / Variants
Device Class
Class I
Regulation
21 CFR Part 862.1660
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent