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The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent: For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.

The Ferritin reagents are ready-to-use liquid reagents. They are supplied in two different package sizes: 200 tests/wedge, 4 wedges/kit and 800 tests/wedge, 4 wedges/kit. In the ADVIA Chemistry Ferritin assay, sample is diluted and reacted with a buffer containing latex particles coated with antibody specific for ferritin. The formation of the antibodyantigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 658 nm. By constructing a standard curve from the absorbance of standards, ferritin concentration of a sample can be determined.

ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid, buffer based product containing multiple analytes derived from human sources. The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required). The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL. Values for the new lots are assigned from a master lot that is referenced to the WHO 3rd International Standard IBSC 94/572

The document describes the Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Ferritin (FRT) Reagent and ADVIA® Chemistry Liquid Specific Protein Calibrator. The study presented focuses on the Ferritin Reagent and its comparison to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly based on the correlation between the new device and the predicate device. The primary performance metric reported is a method comparison study.

The reported performance, with a slope of 1.00 and an intercept of 0.00 (both with narrow confidence intervals that include these ideal values), indicates a very strong correlation and agreement with the predicate device, thereby meeting the implicit acceptance criteria for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 47 patient samples
• Data Provenance: Not explicitly stated whether the samples were retrospective or prospective, nor their country of origin. The term "patient samples" is general.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The ground truth in this context is established by the measurements from the predicate device (N Latex Ferritin assay), which is an established, legally marketed device. There is no mention of experts establishing a separate ground truth for these samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study is a quantitative measurement comparison between two devices, not a diagnostic interpretation or classification that would typically involve an adjudication process by experts. Performance is determined by statistical correlation, not expert consensus on individual case interpretations.

5. 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

This information is not applicable/provided. This device is an in vitro diagnostic reagent and calibrator for automated chemistry systems, not an imaging or interpretive AI device that involves human readers/interpreters. Therefore, an MRMC study or AI assistance comparison is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone study was done. The method comparison data presented is for the ADVIA 1650 Chemistry Ferritin assay (the new device) operating as an algorithm/system, without human interpretation influencing the measurement results directly. The output is a quantitative ferritin concentration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison study was effectively established by the predicate device's measurements (N Latex Ferritin assay). The new device's performance is being assessed against the established performance of the predicate device, assuming the predicate device provides accurate measurements within its validated range.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes a comparison study for a fully developed reagent and calibrator, not a software algorithm that typically undergoes a training phase with a distinct training set. The development of the assay itself would involve internal validation and optimization, but details of such a "training set" are not part of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is largely not applicable in the context of a reagent-based IVD requiring predicate comparison. For the development and internal validation of such a system, ground truth would typically be established through highly accurate reference methods, certified reference materials, or correlation with established laboratory methods to ensure accuracy and precision. However, details of this process for the new device's internal development are not part of the publicly available 510(k) summary.

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