Home / 510(k) Clearances / K050100

510(k) K050100

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER by Bionostics, Inc. — Product Code JJX

K050100 is an FDA 510(k) premarket notification submitted by Bionostics, Inc. for the device "RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER". The FDA issued a decision of Substantially Equivalent on February 25, 2005. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bionostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2005
Date Received
January 18, 2005
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

Other clearances by Bionostics, Inc.

  • K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (May 31, 2013)
  • K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (February 14, 2013)
  • K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER (January 25, 2013)
  • K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (January 30, 2012)
  • K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (December 23, 2011)
  • K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (September 19, 2011)
  • K103553 — LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (February 10, 2011)
  • K101831 — ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 (October 1, 2010)
  • K091914 — OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (November 6, 2009)
  • K081478 — RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (October 6, 2008)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161526 — LIAISON CMV 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)

FDA data resources