510(k) · Cleared
Recalled · Class II · 2024Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen · CGA Glucose Oxidase, Glucose
Cleared on May 15, 2013 after a 441-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 5 times.
- Decided
- May 15, 2013
- Review
- 441 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK120615 Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile -…Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen · 2013
- Descendant · cites it directly · 0 of its ownK223179 Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120615 | Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu Cassette | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013 | — |
| +1 | K223179 | Cholestech LDX ™ System | Alere San Diego, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 CGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | Alere Cholestech LDX Analyzer ROM pack software version v3.30 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223179 | Cholestech LDX ™ System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class II | Z-1702-2024 | Labeling design | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock… |
| Jun 24, 2022 | Class II | Z-1508-2022 | Device Design | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL… |
| Feb 15, 2019 | Class II | Z-2475-2019 | Employee error | The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable. |
| Aug 2, 2016 | Class III | Z-2778-2016 | Packaging | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. |
| Oct 23, 2013 | Class III | Z-0379-2014 | Labeling Change Control | Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K223179 (Alere San Diego, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Alere Cholestech LDX®V System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile*GLU Cassette is for the quantitative determination of total cholesterol, HOL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/l-DL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are…
Read the full statement (172 words)
The Alere Cholestech LDX®V System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile*GLU Cassette is for the quantitative determination of total cholesterol, HOL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/l-DL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDXX@ Analyzer.
* Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
* HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.-
" Triglyceride measurements are used in thediagnosis and treatment of patients with diabetes mellitus, nephrosis. liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
* Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120615: Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120615
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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