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510(k) K172133

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay by Axis-Shield Diagnostics, Ltd. — Product Code CDD

K172133 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay". The FDA issued a decision of Substantially Equivalent on October 27, 2017. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2017
Date Received
July 14, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

Other clearances by Axis-Shield Diagnostics, Ltd.

  • K253539 — Alere NT-proBNP for Alinity i (February 18, 2026)
  • K241176 — Alere NT-proBNP for Alinity i Reagent Kit (January 16, 2025)
  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)
  • K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (December 12, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (December 19, 2011)
  • K110296 — AXIS-SHIELD ANTI-CCP (August 18, 2011)
  • K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P (September 25, 2009)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)

Other clearances for product code CDD

  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
  • K223289 — Access Vitamin B12 (December 23, 2022)
  • K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Acc (October 4, 2019)
  • K192064 — LIAISON Vitamin B12 (October 2, 2019)
  • K161721 — Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin (September 20, 2016)
  • K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active- (July 26, 2016)
  • K151786 — Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (September 24, 2015)
  • K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYP (September 16, 2014)
  • K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL (January 2, 2014)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)

FDA data resources