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Good Biotech Corp. (GBC) Ferritin LIT Assay is intended to be used for the quantitative determination of ferritin in human serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism.

GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples.

GBC ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis.

For In Vitro Diagnostic Use.

For Prescription Use Only

Good Biotech Corp. Ferritin LIT Assay is a ready to use reagent for the quantitative determination of ferritin by latex particle enhanced immunoturbidimetry (LIT). Duck anti-ferritin IgY(ΔFc) is coupled to polystyrene microparticles, which greatly increase the analytical sensitivity. When ferritin of the sample encounters with the latex microparticles sensitized with duck anti-ferritin IgY(AFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the ferritin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual ferritin concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known ferritin concentrations.

This 510(k) submission describes the Ferritin LIT Assay, Ferritin Calibrator Set, and Ferritin Controls (Level-L & Level-H) developed by Good Biotech Corp. The purpose of the study was to demonstrate substantial equivalence to a predicate device, the Biokit quantex Ferritin system.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, a "high correlation coefficient" is an implicit acceptance criterion for demonstrating substantial equivalence based on comparative performance studies.

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

• Sample Size: 50 serum samples
• Data Provenance: Retrospective (clinical samples for comparative study). The country of origin is not specified but given the submitter is in Taiwan, it is likely the samples were sourced there.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantifying ferritin in human serum. The "ground truth" for comparative studies in IVD typically refers to the results obtained from a reference method (the predicate device in this case) rather than expert interpretation of images or other subjective data. No human experts were involved in establishing the "ground truth" in the way described for medical imaging devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used when subjective interpretations are involved, such as in clinical trials or medical imaging studies to resolve discrepancies among experts. This study involves quantitative measurements, where the "ground truth" is established by the predicate device's numerical output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess improvements in reader performance. This device is an automated IVD assay, not a device requiring human interpretation of complex data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study conducted was a standalone performance of the device. The Ferritin LIT Assay directly measures ferritin concentration in serum samples without human intervention in the measurement process (beyond sample handling and initiation of the automated analyzer). The comparison was between the new assay and the predicate device's measurements.

7. The Type of Ground Truth Used

The "ground truth" used for the comparative study was the results obtained from the predicate device (Biokit quantex Ferritin). This is a common practice in IVD substantial equivalence demonstrations, where the new device's performance is compared against an already legally marketed and accepted device.

8. The Sample Size for the Training Set

The document does not report a separate training set size. For IVD assays, development often involves internal optimization and calibration using various samples, but a formally defined "training set" in the context of machine learning or AI is not typically described in these types of 510(k) summaries unless the device incorporates such algorithms. The 50 serum samples mentioned were for the comparative performance study (test set).

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

Since a distinct "training set" (as typically defined in AI/ML contexts) is not described, the method for establishing its "ground truth" is not provided. For IVD assay development, calibration is typically performed using calibrators with known concentrations, and controls are used to verify performance within established ranges. The "GBC Ferritin Calibrator Set" and "GBC ferritin Controls" are mentioned as being used with the assay to establish the calibration curve and for quality control, respectively. These materials would have their "ground truth" concentrations established through rigorous analytical methods by the manufacturer.

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