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510(k) K162173

Elecsys CYFRA 21-1 CalCheck 5 by Roche Diagnostics — Product Code JJX

K162173 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys CYFRA 21-1 CalCheck 5". The FDA issued a decision of Substantially Equivalent on January 12, 2017. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Roche Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2017
Date Received
August 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
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 JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)
  • K150955 — Elecsys Progesterone III Cal Check 5 (May 1, 2015)

FDA data resources