# K072638: Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 19, 2007 after 31 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 1.

## Indications for use
In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as metabolic or nutritional disorders. Protein measurements in urine are 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 diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.

Source page: https://510kreport.com/device/K072638
Methodology: https://510kreport.com/methodology