Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions— 510(k) K253490
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K253490 for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions, Substantially Equivalent on 2026-02-12. Applicant: Roche Diagnostics. Device class: 2.
Summary
Roche Diagnostics lists three items: Glucose HK Gen.3, ONLINE DAT Methadone II, and cobas pro integrated solutions. They're filed under product code CFR, hexokinase, glucose. The record doesn't describe them beyond those names and that code name.
Class II, 21 CFR 862.1345. Clinical Chemistry is both the classification panel and the review panel. It came in as a Traditional 510(k).
Roche Diagnostics filed from Indianapolis, Indiana. FDA found it substantially equivalent 111 calendar days after receipt (October 24, 2025 to February 12, 2026).
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Product code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CFR
view all- K252357 — Glucose2
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
- K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
More clearances from Roche Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.