# K974858: Phosphorus-SL Assay, Catalogue Number 117-10, 117-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jan 30, 1998 after 32 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
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.

## Indications for use
For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate). (1) The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique (2).

Source page: https://510kreport.com/device/K974858
Methodology: https://510kreport.com/methodology