# K151487: Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE,  Diatron Glucose Hexokinase Method

- Pathway: 510(k) (Traditional)
- Applicant: Diatron U.S., Inc.
- Decided: Jan 14, 2016 after 226 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K101741 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101741: Diatron Pictus 400, Diatron Group (2011) Summary page 4.

## Indications for use
Diatron Glucose Hexokinase Method is for the in vitro quantitative determination of Glucose in serum for use with Diatron Pictus 700 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes. Diatron ISE is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (CI-) concentrations in serum on the Diatron Pictus 700 Chemistry Analyzer. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used in monitoring electrolyte balance and in the diagnosis and treatment of diseases/conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. The Diatron Pictus 700 Clinical Chemistry Analyzer is a wet-chemistry analyzer for the direct determination of sodium, potassium, chloride and glucose concentrations in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. It is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K151487
Methodology: https://510kreport.com/methodology