(15 days)
The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The ARCHITECT B12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum and plasma using the ARCHITECT B12 Reagent Kit.
The ARCHITECT B12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma when using the ARCHITECT B12 Reagent Kit.
The ARCHITECT B12 assay is a two-step assay with an automated sample pretreatment, for determining the presence of B12 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.
The ARCHITECT B12 Reagent Kit consists of 100 (1 x 100) or 500 (1 x 500) tests. Each kit contains 1 bottle each of the following reagents: ARCHITECT B12 Microparticles, ARCHITECT B12 Conjugate, ARCHITECT B12 Assay Diluent, ARCHITECT B12 Pre-Treatment Reagent 1, ARCHITECT B12 Pre-Treatment Reagent 2, ARCHITECT B12 Pre-Treatment Reagent 3.
Each ARCHITECT B12 Calibrator Kit contains 6 Bottles (4 mL each) of ARCHITECT B12 Calibrators (1 bottle each of Calibrators A – F).
Each ARCHITECT B12 Control Kit contains 3 bottles (8 mL each) of ARCHITECT B12 Controls (1 bottle of low control, 1 bottle of medium control, and 1 bottle of high control).
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"1. A table of acceptance criteria and the reported device performance": {
"Precision": {
"Acceptance Criteria": "
§ 862.1810 Vitamin B
12 test system.(a)
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.(b)
Classification. Class II.