# K120615: Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen
- Decided: May 15, 2013 after 441 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alere Cholestech LDX Analyzer ROM pack software version v3.30: named in the summary without a submission number

## Most influential descendants
- K223179: Cholestech LDX ™ System (2023), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class II · Z-1702-2024: 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 abras
- Jun 24, 2022 · Class II · Z-1508-2022: 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 
- Feb 15, 2019 · Class II · Z-2475-2019: 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: Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
- Oct 23, 2013 · Class III · Z-0379-2014: 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 in

## Indications for use
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.

Source page: https://510kreport.com/device/K120615
Methodology: https://510kreport.com/methodology