# K071239: Total Protein Urine/CSF Gen.3

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Sep 14, 2007 after 134 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K141925: Total Protein Urine/CSF Gen.3 (2014), 0 descendants of its own

## Indications for use
TOTAL PROTEIN URINE / CSF Gen 3. In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS iNTEGRA systems. 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 disease conditions such as meningitis, brain tumors and infections of the central nervous systems. C.f.a.s. TPUC 200 C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems.

Source page: https://510kreport.com/device/K071239
Methodology: https://510kreport.com/methodology