# K981118: PHOS

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 12, 1998 after 77 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 K872494 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883962: Roche Reagent for Inorganic Phosphorus, Roche Diagnostic Systems, Inc. (1988) Summary page 1.
- K872494: Hitachi 717 Chemistry Analyzer, Boehringer Mannheim Corp. (1987) Summary page 1.

## Indications for use
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Source page: https://510kreport.com/device/K981118
Methodology: https://510kreport.com/methodology