# K993480: K-Assay Haptoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 24, 1999 after 41 days
- Product code: DAD (Haptoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5460
- 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
The K-ASSAY Haptoglobin Assay is intended to be used for the quantitative determination of Haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) relating to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993480
Methodology: https://510kreport.com/methodology