510(k) · Cleared
ClearedUrinary/CSF Protein
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JGQ Turbidimetric, Total Protein
Cleared on Sep 13, 1991 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 13, 1991
- Review
- 31 days
- Class
- Class II
- Product code
- JGQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK913615 Urinary/CSF ProteinBoehringer Mannheim Corp. · 1991
- Descendant · cites it directly · 1 of its ownK071239 Total Protein Urine/CSF Gen.3Roche Diagnostics · 2007
- Descendant · 2 generations on · 0 of its ownK141925 Total Protein Urine/CSF Gen.3Roche Diagnostics Operations (Rdo) · 2014
- Descendant · cites it directly · 0 of its ownK072638 Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801Roche Diagnostics Corp. · 2007
- Descendant · cites it directly · 0 of its ownK981295 UPROAbbott Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK981682 UPROAbbott Laboratories · 1998
Most influential descendants
Showing 5 of 5 · See all- K071239Total Protein Urine/CSF Gen.3Roche Diagnostics · 2007 · cites it directly1descendant
- K141925Total Protein Urine/CSF Gen.3Roche Diagnostics Operations (Rdo) · 2014 · 2 generations on0descendants
- K072638Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801Roche Diagnostics Corp. · 2007 · cites it directly0descendants
- K981295UPROAbbott Laboratories · 1998 · cites it directly0descendants
- K981682UPROAbbott Laboratories · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913615 | Urinary/CSF Protein | Boehringer Mannheim Corp. | 1991 | — |
| +1 | K071239 | Total Protein Urine/CSF Gen.3 | Roche Diagnostics | 2007 | — |
| +2 | K141925 | Total Protein Urine/CSF Gen.3 | Roche Diagnostics Operations (Rdo) | 2014 | — |
| +1 | K072638 | Roche/Hitachi Urinary/CSF Protein with Model (S) Cat #11877801 | Roche Diagnostics Corp. | 2007 | — |
| +1 | K981295 | UPRO | Abbott Laboratories | 1998 | — |
| +1 | K981682 | UPRO | Abbott Laboratories | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2007 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K071239 (Roche Diagnostics, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JGQ devicesJGQ Turbidimetric, Total Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K913615 · printed Nov 4, 2026
Cite this page
510(k) Report. “K913615: Urinary/CSF Protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913615
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026