ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
FDA 510(k) K253491 · Roche Diagnostics
510(k) numberK253491
Submission
- Device name
- ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- October 24, 2025
- Decision date
- February 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
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| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | Diamond Diagnostics, Inc. | 08/30/2012SE |
| K112995 | Gem Premier 4000CEM · Traditional | Instrumentation Laboratory CO | 05/03/2012SE |
| K110520 | Biolis 12ICEM · Traditional | Tokyo Boeki Medisys, Inc. | 03/23/2012SE |
| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | Beckman Coulter, Inc. | 12/23/2011SE |
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | Polymedco, Inc. | 11/04/2011SE |
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| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
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Questions and answers
When was ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions cleared by the FDA?
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491) received a 510(k) decision of Substantially Equivalent on February 12, 2026, 111 days after the submission was received.
What is the product code of K253491?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.