510(k) · Cleared
ClearedRoche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JGQ Turbidimetric, Total Protein
Cleared on Oct 19, 2007 as substantially equivalent to K913615 (Boehringer Mannheim Corp., 1991) after a 31-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Oct 19, 2007
- Review
- 31 days
- Class
- Class II
- Product code
- JGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913615 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913615 Urinary/CSF ProteinBoehringer Mannheim Corp. · 1991
- This deviceK072638 Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801Roche Diagnostics Corp. · 2007
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) | K072638 | Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801 | Roche Diagnostics Corp. | 2007 | — |
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…in test system. The reagent was originally cleared as an endpoint, turbidimetric assay for use as Roche/Hitachi Urinary/CSF Protein via K913615. Subsequent to this filing, a rate (kinetic) application was developed, in addition to the original endpoint ass… | 1991 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K913615.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072638: Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072638
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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