# K132031: Afinion Lipid Panel and Afinion Lipid Panel Control

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Poc AS
- Decided: Mar 21, 2014 after 246 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K842280 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031824: Cobas Integra Cholesterol Gen. 2, Roche Diagnostics Corp. (2003) Summary page 1.
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents, Roche Diagnostic Systems, Inc. (1997) Summary page 1.
- K982341: Direct HDL-Cholestrol Liquid, Randox Laboratories, Ltd. (1998) Summary page 1.
- K061182: Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus AU Systems;Qalib, Cliniqa Corporation (2006) Summary page 2.

## Indications for use
The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS 100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS 100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS 100 Analyzer System is working properly and provides reliable results. For use in clinical laboratories and point of care laboratory settings.

Source page: https://510kreport.com/device/K132031
Methodology: https://510kreport.com/methodology