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510(k) K192072

Tina-quant C-Reactive Protein IV by Roche Diagnostics Operations (Rdo) — Product Code DCN

K192072 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "Tina-quant C-Reactive Protein IV". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
August 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Roche Diagnostics Operations (Rdo)

  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K183517 — Ammonia II (February 8, 2019)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (November 5, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (December 19, 2016)
  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K161817 — Tina-quant Cystatin C Gen.2 (July 27, 2016)
  • K160570 — Creatine Kinase (May 25, 2016)
  • K152245 — ONLINE TDM Vancomycin Gen.3 (January 8, 2016)
  • K151578 — Carbamazepine Gen 4 (October 22, 2015)

Other clearances for product code DCN

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)
  • K083412 — PATHFAST HSCRP (March 9, 2009)

FDA data resources