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

K172133 · Axis-Shield Diagnostics, Ltd. · CDD · Oct 27, 2017 · Clinical Chemistry

Device Facts

• Record ID: K172133
• Device Name: ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
• Applicant: Axis-Shield Diagnostics, Ltd.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Indications for Use

The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

Device Story

The ADVIA Centaur Active-B12 (AB12) assay is a fully automated, two-step direct chemiluminescent immunoassay used on the ADVIA Centaur XP/XPT system. It measures holotranscobalamin (holoTC) in human serum samples. The assay uses an acridinium ester-labeled anti-transcobalamin antibody as the Lite Reagent and biotinylated anti-holotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles as the Solid Phase. The device is used in clinical laboratory settings by trained technicians. The output is a quantitative concentration of holoTC (pmol/L), which healthcare providers use to assist in diagnosing and managing vitamin B12 deficiency. The modification in this submission updates the calibration traceability to the WHO International Standard (NIBSC Code 03/178).

Clinical Evidence

Bench testing only. Verification and validation activities performed to confirm impact of calibration modification against WHO International Standard (03/178).

Technological Characteristics

In vitro diagnostic immunoassay; automated system-based; calibration traceable to WHO International Standard (03/178).

Indications for Use

Indicated for the quantitative measurement of holotranscobalamin (holoTC) in human serum to aid in the diagnosis and treatment of vitamin B12 deficiency in patients.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay (k160757)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k172133

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay – k160757

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was made to the calibration to be traceable to the WHO International Standard for Holotranscobalamin (03/178).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, and performance characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.