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510(k) K162526

Creatine Kinase-MB by Roche Diagnostics — Product Code JHW

K162526 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Creatine Kinase-MB". The FDA issued a decision of Substantially Equivalent on May 26, 2017. The device falls under product code JHW (U.V. Method, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Roche Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2017
Date Received
September 9, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Method, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K252280 — Elecsys Anti-SARS-CoV-2 S (April 13, 2026)
  • K260048 — Elecsys Anti-HAV IgM (April 7, 2026)
  • K260046 — Elecsys Anti-HBc II (April 7, 2026)
  • K260049 — Elecsys Anti-HBc IgM (April 7, 2026)
  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)

Other clearances for product code JHW

  • K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (July 18, 2014)
  • K122083 — ELITECH CLINICAL SYSTEMS CK NAC SL (August 22, 2012)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K003158 — ROCHE DIAGNOSTICS CK-MB (December 18, 2000)
  • K961501 — ELECSYS CK-MB (June 11, 1996)
  • K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (March 13, 1995)
  • K944325 — LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (February 22, 1995)
  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K935924 — AXSYM CK-MB (June 21, 1994)
  • K931050 — CARDIO REP CK ISOENZYME KIT - 3310 (April 20, 1993)

FDA data resources