510(k) · Cleared
ClearedTotal Protein Urine/CSF Gen.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JGQ Turbidimetric, Total Protein
Cleared on Sep 14, 2007 as substantially equivalent to K913615 (Boehringer Mannheim Corp., 1991) after a 134-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Sep 14, 2007
- Review
- 134 days
- Class
- Class II
- Product code
- JGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913615 (1991). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K141925Total Protein Urine/CSF Gen.3Roche Diagnostics Operations (Rdo) · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913615 | Urinary/CSF Protein | Boehringer Mannheim Corp. | 1991 | — |
| 0 (this device) | K071239 | Total Protein Urine/CSF Gen.3 | Roche Diagnostics | 2007 | — |
| +1 | K141925 | Total Protein Urine/CSF Gen.3 | Roche Diagnostics Operations (Rdo) | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913615 | Urinary/CSF ProteinSummary page 1…o our Total Protein submission Urine /CSF (TPUC) test system. The reagent was originally cleared for use as: Roche Hitachi Urinary/CSF Protein via K913615. The modification that triggered the need for this filing was the development of a new applica… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141925 | Total Protein Urine/CSF Gen.3 | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JGQ devicesJGQ Turbidimetric, Total Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JGQ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · JGQ
Too few JGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JGQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGQ
4in 2025
MAUDE reports naming product code JGQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (150 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071239 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071239: Total Protein Urine/CSF Gen.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071239
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026