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 Operations (Rdo) · JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Dec 9, 2014 as substantially equivalent to K071239 (Roche Diagnostics, 2007) after a 146-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Dec 9, 2014
- Review
- 146 days
- Class
- Class I
- Product code
- JIQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913615 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 JIQ? 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 |
|---|---|---|---|
| * | K071239 | Total Protein Urine/CSF Gen.3Summary page 4…ion of the predicate device. The device name, device TPUC3 Total Protein Urine/CSF Gen.3, is unchanged from how it was cleared in 510(k) K071239. Regulatory Table 1: Regulatory Classification of Candidate Device classification of Device Classification Name… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 16.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JIQ devicesJIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JIQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · JIQ
Too few JIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JIQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIQ
9in 2025
MAUDE reports naming product code JIQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141925: Total Protein Urine/CSF Gen.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141925
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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