510(k) · Cleared
Recalled · Class III · 2015Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere, San Diego, Dba Biosite INcorporated, Dba IN · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Dec 21, 2010 as substantially equivalent to K913687 (Streck Laboratories, Inc., 1991) after a 92-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 3 times.
- Decided
- Dec 21, 2010
- Review
- 92 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913687 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913687 Chem-ChexStreck Laboratories, Inc. · 1991 · Recalled
- This deviceK102700 Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration…Alere, San Diego, Dba Biosite INcorporated, Dba IN · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913687 | Chem-Chex | Streck Laboratories, Inc. | 1991 | 5 |
| 0 (this device) | K102700 | Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification… | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913687 | Chem-ChexSummary page 1…21 CER 862.1660 Product Code: JJY Panel: Clinical Chemistry Predicate devices: K9 13687 CHEM-CHEX (Streck Laboratories, Inc.)… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 27, 2015 | Class III | Z-0122-2016 | Error in labeling | 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 | Component design/selection | Out of range (increased) HDL Cholesterol results. |
| Oct 22, 2012 | Class III | Z-0747-2013 | Component design/selection | Out of range (increased) HDL Cholesterol results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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®…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102700: Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102700
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026