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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.

Competition principle. Total duration of assay: 18 minutes, 37*C. Competition principic. Total adalabating the sample (15 mL) with the •] * incubation (9 immutes). By metreatment 2 (15 mL), bound Vitamin B12 is liberated into the serum.

·2nd incubation (9 minutes): By incubating the pretreated sample with the •2nd incubation (9 innutes): Dy most, and immunocomplex is formed, the ruthenylated" * " intrilisic Tactor (70 this), " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = · 3rd incubation (9 minutes): After addition of of streptaviding of a streptaviding of the still, •3rd incubation (9 mL) and Vitamin B12 labeled with biotin (60 mL), the still-

microparticles (30 mL) and Vitalini Dr.2 recorder become occupied, with the vacant sites of the ruthenylated Intrinst For and B12 biotin complex.
formation of an ruthenylated Intrinsic Factor-Viraming of biotin formation of an rutherrylated markisto i actor-phase via interaction of biotin.
The entire complex becomes bound to the solid phase via interaction of biotin. and streptavidin.

·The reaction mixture is aspirated into the measuring cell where the · I he reaction inixture is aspirated onto the surface of the electrode. microparticles are then removed with Procell. Application of a voltage Unbound substances are then removed was a secure in which is measured
to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).

·Results are determined via a calibration curve which is instrument-· Results are 'delemined ' via- a 'culturation and a master curve provided via the reagent bar code.

**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)**3)

The provided document is a 510(k) Summary for the Boehringer Mannheim Elecsys Vitamin B12 Assay. It describes the device, its intended use, and compares its performance characteristics to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of pass/fail thresholds for the Elecsys Vitamin B12 assay. Instead, the document presents performance characteristics of the Elecsys Vitamin B12 assay and the predicate device (BioRad Quantaphase II B12/Folate Radioassay) for comparison, implying that the Elecsys device's performance should be comparable or superior. The specific performance metrics reported are:

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