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The B12 Flex® reagent cartridge is an in vitro product for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension® EXI" integrated chemistry system. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of the gastrointestinal malabsorption.

The FOL Flex® reagent cartridge is an in vitro product for the quantitative measurement of Folate in human serum on the Dimension® EXL™ integrated chemistry system. Measurements of folate are used in the diagnosis and treatment of megaloblastic anemia

The B12 method is an in vitro diagnostic device that consists of pre-packaged reagents in a plastic eight well cartridge for use on the Dimension EXL™ integrated chemistry svstem. The vitamin B12 method is a homogeneous, competitive chemiluminescent immunoassay based on LOCl® technology. LOCI® reagents include two synthetic bead reagents and biotinylated intrinsic factor (IF). The first bead reagent (Chemibeads) is coated with a B12 derivative and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The patient sample is pretreated with Sodium Hydroxide (NaOH) to release the serum B12 from its carrier proteins. Potassium cyanide (KCN) is added to convert all the forms of B12 into a single, cyanocobalamin form, and dicyanocobinamide is added to keep the B12 from rebinding with the carrier proteins. After the sample pretreatment, the biotinylated IF and chemibead reagents are added sequentially to the reaction vessel. Vitamin B12 from the sample competes with the B12-chemibead for a limited amount of biotinylated IF. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from the Sensibeads which diffuses to the Chemibeads triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the concentration of vitamin B12 in the sample.

The FOL method is an in vitro diagnostic device that consists of pre-packaged reagents in a plastic eight well cartridge for use on the Dimension EXL™ integrated chemistry svstem. The Folate method is a homogeneous, competitive chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and labeled folate binding protein (FBP). The first bead reagent (Chemibeads) is coated with a folic acid derivative and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. Before the immunological portion of the reaction is initiated, the patient sample is pretreated with Sodium Hydroxide (NaOH) and Dithioerythritol (DTE) to release serum folate from endogenous folate binding protein (FBP) and to maintain 5-methyltetrahydrofolate in its reduced form. After the sample pretreatment, chemibeads and labeled folate binding reagent are added sequentially to the reaction vessel. Folate from the patient sample competes with the folate-chemibead for a limited amount of labeled FBP. Sensibeads are then added and bind to the biotinylated portion of the labeled FBP to form bead pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from the Sensibeads which diffuses to the Chemibeads triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the concentration of folate in the sample.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes two devices, the Dimension® EXL™ B12 and Dimension® EXL™ FOL Methods, and their substantial equivalence to predicate devices (Dimension Vista® B12 Flex and Dimension Vista® Folate Flex). The acceptance criteria are implicitly defined by the results of the method comparison studies, aiming to demonstrate strong correlation and agreement between the new devices and the predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted was a split sample method comparison to demonstrate substantial equivalence to the legally marketed predicate devices.

1. Sample size used for the test set and the data provenance:

   • Dimension® B12 Flex®: 233 human serum samples.
   • Dimension® FOL Flex®: 138 human serum samples.
   • Data Provenance: The document only states "human serum samples." It does not specify the country of origin or whether the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" in this context is the performance of the legally marketed predicate devices (Dimension Vista® B12 Flex and Dimension Vista® Folate Flex). The study compares the new device's performance against the established performance of the predicate.

3. Adjudication method for the test set: Not applicable. This was a method comparison study between two analytical instruments, not a study involving human interpretation or adjudication for ground truth.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-based diagnostic imaging device, but an in vitro diagnostic chemistry system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in effect. The study evaluated the performance of the new device (Dimension® EXL™ B12/FOL) as a standalone analytical instrument compared to the predicate device, both operating without human interpretation of results beyond standard laboratory practices. The "algorithm only" in this case refers to the automated immunoassay technology.

6. The type of ground truth used: The "ground truth" was effectively the measurements obtained from the legally marketed predicate devices (Dimension Vista® B12 Flex and Dimension Vista® Folate Flex). The study aimed to show that the new devices produced comparable results.

7. The sample size for the training set: Not applicable. This document describes a 510(k) submission for a new in vitro diagnostic test, specifically focusing on demonstrating substantial equivalence to a predicate device. It is not an AI model requiring a distinct "training set" in the machine learning sense. The development of such assays involves extensive R&D and calibration, but not typically a "training set" as defined for AI/ML.

8. How the ground truth for the training set was established: Not applicable, as no training set was explicitly mentioned or used in this context.

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