# K102700: Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification Materials

- Pathway: 510(k) (Traditional)
- Applicant: Alere, San Diego, Dba Biosite INcorporated, Dba IN
- Decided: Dec 21, 2010 after 92 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913687 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913687: Chem-Chex, Streck Laboratories, Inc. (1991) Summary page 1.

## Recalls of this device
- Aug 27, 2015 · Class III · Z-0122-2016: 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.
- Oct 22, 2012 · Class III · Z-0746-2013: Out of range (increased) HDL Cholesterol results.
- Oct 22, 2012 · Class III · Z-0747-2013: Out of range (increased) HDL Cholesterol results.

## Indications for use
Lipid Controls: Alere Cholestech LDX® Lipid Controls, Level 1 and Level 2, are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System. Multianalyte Controls: Alere Cholestech LDX® Multianalyte Controls, Level 1 and Level 2, are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System. Calibration Verification Materials: Alere Cholestech LDX® Calibration Verification, Levels 1-4, are designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. This material is intended for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.

Source page: https://510kreport.com/device/K102700
Methodology: https://510kreport.com/methodology