# K141925: Total Protein Urine/CSF Gen.3

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Dec 9, 2014 after 146 days
- Product code: JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913615 (1991). 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)
- K071239: Total Protein Urine/CSF Gen.3, Roche Diagnostics (2007) Summary page 4.

## Indications for use
In vitro test for the quantitative determination of the total protein concentration in urine and cerebral spinal fluid. Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders. CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous systems.

Source page: https://510kreport.com/device/K141925
Methodology: https://510kreport.com/methodology