510(k) · Cleared
Recalled · Class II · 2026Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CFR Hexokinase, Glucose
Cleared on Aug 16, 2019 as substantially equivalent to K060373 (Roche Diagnostics, 2006) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 16, 2019
- Review
- 31 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953239 (1995). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 1 generation backK060373 Cobas 6000 Series SystemRoche Diagnostics · 2006 · Recalled
- This deviceK191899 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro…Roche Diagnostics · 2019
- Descendant · cites it directly · 0 of its ownK253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl…Roche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated…Roche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK220134 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na…Roche Diagnostics · 2022
Most influential descendants
Showing 3 of 3 · See all- K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics · 2026 · cites it directly0descendants
- K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics · 2026 · cites it directly0descendants
- K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −1 | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | 10 |
| 0 (this device) | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated… | Roche Diagnostics | 2019 | — |
| +1 | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for… | Roche Diagnostics | 2026 | — |
| +1 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | 2026 | — |
| +1 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2… | Roche Diagnostics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 2 | 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 CFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K060373 | Cobas 6000 Series SystemSummary page 13…e 2: Substantial Equivalency System Topic cobas 6000 Analyzer Series cobas pro integrated (k060373) solutions (k191899)… | 2006 |
| * | K190773 | Elecsys TSHSummary page 15…SH Elecsys TSH Item ( e 801 in cobas 8000 core) (e 801 in cobas pro core) k190773 k191899 Proprietary name Elecsys TSH Elecsys TSH Cata… | 2019 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas… | 2026 | 0 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | 2026 | 0 |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2026 | Class II | Z-1476-2026 | Software design | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and… |
| Dec 8, 2020 | Class II | Z-0755-2021 | Software design | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may… |
| Nov 23, 2020 | Class II | Z-0752-2021 | Device Design | During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K253491 (Roche Diagnostics, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K060373.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The cobas pro integrated solutions is an IVD device used for the quantitation of clinical chemistry/ immunochemistry and Ion Selective Electrolyte parameters from various biological fluids. Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on Roche/Hitachi cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including…
Read the full statement (197 words)
The cobas pro integrated solutions is an IVD device used for the quantitation of clinical chemistry/ immunochemistry and Ion Selective Electrolyte parameters from various biological fluids.
Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on Roche/Hitachi cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors.
The ISE indirect Na for Gen. 2 is intended for the quantitative determination of sodium in serum, plasma or urine using ion‑selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Elecsys TSH immunoassay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191899: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191899
Report an extraction error
Are you the manufacturer?
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