# K053253: Hemocue Albumin 201 Analyzing System

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue AB
- Decided: Feb 17, 2006 after 88 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Clinitek 50 Urine Chemistry Analyzer: named in the summary without a submission number

## Recalls of this device
- Jul 16, 2013 · Class II · Z-0086-2014: HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.
- Nov 7, 2012 · Class III · Z-0619-2013: Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.

## Indications for use
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed system, the HemoCue Albumin 201 System. The system is designed be used for the quantitative determination of low levels of albumin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes.

Source page: https://510kreport.com/device/K053253
Methodology: https://510kreport.com/methodology