# K041230: Clinical Laboratory Analyzing System

- Pathway: 510(k) (Special)
- Applicant: Hemocue, Inc.
- Decided: May 20, 2004 after 10 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 7, 2010 · Not classified · Z-1848-2011: Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance 

## Indications for use
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201 DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. The use of any other device in the HemoCue Glucose 201 DM Analyzer except the HemoCue Glucose 201 Microcuvettes is neither supported not recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Glucose 201 Microcuvettes are for in vitro use only.

Source page: https://510kreport.com/device/K041230
Methodology: https://510kreport.com/methodology