Access Vitamin B12
Device Facts
| Record ID | K223289 |
|---|---|
| Device Name | Access Vitamin B12 |
| Applicant | Beckman Coulter, Inc. |
| Product Code | CDD · Clinical Chemistry |
| Decision Date | Dec 23, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1810 |
| Device Class | Class 2 |
Indications for Use
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Device Story
Access Vitamin B12 assay is a competitive binding immunoenzymatic assay; utilizes paramagnetic particles coated with goat anti-mouse IgG and mouse monoclonal anti-intrinsic factor; conjugate is intrinsic factor-alkaline phosphatase. Input: human serum or plasma samples. Process: two-step competitive chemiluminescent immunoassay performed on Dxl 9000 Access Immunoassay Analyzer. Output: quantitative vitamin B12 concentration (pg/mL). Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing and managing anemias related to gastrointestinal malabsorption.
Clinical Evidence
Bench testing only. Method comparison study (N=122) vs. predicate showed R2=0.97, slope 1.00 (95% CI 0.96-1.02). Imprecision study (N=84 per sample) demonstrated within-laboratory CV 2.7-7.7% for concentrations >100 pg/mL. Linearity verified across 68-1,500 pg/mL range. LoB 35 pg/mL, LoD 49 pg/mL, LoQ 49 pg/mL.
Technological Characteristics
Paramagnetic particle, chemiluminescent immunoassay. Solid phase: paramagnetic particles coated with goat anti-mouse IgG and mouse monoclonal anti-intrinsic factor. Conjugate: intrinsic factor-alkaline phosphatase. Two-step competitive binding principle. Automated analysis on Dxl 9000 system. Liquid ready-to-use reagent format. Standardization: USP Reference Material.
Indications for Use
Indicated for quantitative determination of vitamin B12 in human serum and plasma (heparin) to aid in diagnosis and treatment of anemias of gastrointestinal malabsorption.
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.
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