# K990036: Careside Lytes, Careside Anallyzer Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Mar 18, 1999 after 71 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- 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 K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
CARESIDE LYTES™ For in vitro diagnostic use with the CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance. CARESIDE Analyzer™ For in vitro diagnostic use by laboratory professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes.

Source page: https://510kreport.com/device/K990036
Methodology: https://510kreport.com/methodology