Atlas FDA

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

FDA 510(k) clearance K172133 · decided 2017-10-27

Clearance details

K-number
K172133
Device name
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
Applicant
Axis-Shield Diagnostics, Ltd.
Decision
Substantially Equivalent
Date received
2017-07-14
Decision date
2017-10-27
Days to decision
105 days
Clearance type
Special
Product code
CDD
Device class
2
Regulation number
862.1810
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Dundee, GB
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ARCHITECT Active-B12 (Holotranscobalamin) (K233541)Axis-Shield Diagnostics, Ltd.2024-07-31
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LIAISON Vitamin B12 (K192064)DiaSorin, Inc.2019-10-02
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721)Diazyme Laboratories2016-09-20
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (K160757)Axis-Shield Diagnostics Limited2016-07-26
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786)Roche Diagnostics2015-09-24
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (K140496)Beckman Coulter, Inc.2014-09-16
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) (K133512)Siemens Healthcare Diagnostics2014-01-02
AXIS-SHIELD ACVTIVE-B12 (K121946)Axis-Shield Diagnostics, Ltd.2013-03-22
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR (K121994)Siemens Healthcare Diagnostics, Inc.2012-11-30
A/C ENZYMATIC VITAMIN B6 ASSAY (K111260)Anticancer, Inc.2012-07-26

Recalls involving this device

No recalls on record reference this clearance.