510(k) · Cleared
ClearedISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CEM Electrode, Ion Specific, Potassium
Cleared on Feb 12, 2026 as substantially equivalent to K191899 (Roche Diagnostics, 2019) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Feb 12, 2026
- Review
- 111 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930928 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930928 Roche Abuscreen Online for MethadoneRoche Diagnostic Systems, Inc. · 1993
- 2 generations backK983703 Modification to Abuscreen Online for MethadoneRoche Diagnostic Systems, Inc. · 1998
- 1 generation backK021505 Online Dat II Methadone IIRoche Diagnostics Corp. · 2002
- This deviceK253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl…Roche Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930928 | Roche Abuscreen Online for Methadone | Roche Diagnostic Systems, Inc. | 1993 | — |
| −2 | K983703 | Modification to Abuscreen Online for Methadone | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K021505 | Online Dat II Methadone II | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for… | Roche Diagnostics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2019 | 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 CEM? 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 CEM device
- #1 K241037 ABL90 FLEX PLUS Systemscore 10.5 · 7 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 |
|---|---|---|---|
| * | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsSummary page 7…cobas c 703 in cobas pro integrated solutions integrated solutions (K191899) (K253490) Fully automated clinical… | 2019 |
| * | K021505 | Online Dat II Methadone IISummary page 11…Roche/Hitachi Family cobas c 703 (K253490) (K021505) Methodology KIMS, Kinetic interaction of Same… | 2002 |
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 33 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K191899.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semiquantitative, and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements. Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders…
Read the full statement (204 words)
cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semiquantitative, and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.
Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.
Methadone II (MDN2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on cobas c systems at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/masspectrometry (GC-MS).
Methadone 1I provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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/K253491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253491: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; 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/K253491
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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