# K981610: Careside Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Jun 25, 1998 after 56 days
- Product code: CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus)
- Device class: 1
- Regulation: 21 CFR 862.1580
- 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 2.

## Indications for use
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure inorganic phosphorus from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. It is intended for professional laboratory use: not for point of care or physician office laboratory use.

Source page: https://510kreport.com/device/K981610
Methodology: https://510kreport.com/methodology