# K981295: UPRO

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 1, 1998 after 175 days
- Product code: JGQ (Turbidimetric, Total Protein)
- Device class: 2
- Regulation: 21 CFR 862.1635
- 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 K913615 (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)
- K913615: Urinary/CSF Protein, Boehringer Mannheim Corp. (1991) Summary page 2.

## Indications for use
The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the ALCYON™ Analyzer. Identification of urinary protein is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria. CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous system.

Source page: https://510kreport.com/device/K981295
Methodology: https://510kreport.com/methodology