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The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin in the sample and the RLUs detected by the ARCHITECT i System optics.

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT Active-B12 device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are largely implicit in the context of a 510(k) submission seeking "substantial equivalence." The device aims to perform as well as the predicate device (AxSYM Active-B12) across these performance characteristics.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 125 samples
   • Data Provenance: Not explicitly stated (e.g., country of origin). The document indicates "human serum" samples. It's a non-clinical/clinical performance study comparing the new device to a predicate, not a study to establish clinical utility from a population. This type of study is retrospective, as existing samples are used to compare the new device to an established one.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. This is a method comparison study between two quantitative laboratory assays. "Ground truth" is established by the reading of the predicate device (AxSYM Active-B12 (HoloTC) Immunoassay), not by expert opinion.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging studies where expert consensus is needed to define ground truth. For quantitative assays like this, the result from the predicate device serves as the comparator.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This is a comparison between two automated laboratory diagnostic devices, not a study involving human readers.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, this is implicitly a standalone study. The ARCHITECT Active-B12 assay is an automated immunoassay. Its performance is evaluated independently against another automated immunoassay (AxSYM Active-B12). There is no "human-in-the-loop" component for the measurement itself, only for operating the instruments and interpreting the quantitative results.

6. The Type of Ground Truth Used:

   • Comparator (reference) Method: The AxSYM Active-B12 (HoloTC) Immunoassay served as the "ground truth" or reference method for comparison. The study aimed to show substantial equivalence between the new device and this legally marketed predicate device.

7. The Sample Size for the Training Set:

   • Not applicable. This 510(k) summary describes a performance study for a diagnostic assay, not a machine learning algorithm that requires a "training set." The ARCHITECT Active-B12 is a chemistry-based immunoassay.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set mentioned or implied for a device of this type.

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