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The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.

The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.

The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.

The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.

The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details for Demonstrating Acceptance Criteria:

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

• Precision:
  • 6 samples (3 controls, 3 human serum samples) for within-device precision (assayed in duplicate twice a day for 20 days).
  • 50 patient samples (ranging from 5.7 - 884.7 ng/mL) for between-lot precision (tested in duplicate with 3 different lots of reagent).
  • Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
• Linearity / Analytical Range:
  • 11 test concentrations prepared from analyte-spiked normal human serum samples diluted with analyte-depleted normal human serum.
  • Each sample run 4 times.
  • Data provenance not explicitly stated.
• Detection Limits (LoB, LoD, LoQ):
  • LoB: 60 replicates of blank (analyte depleted human serum).
  • LoD: 6 samples diluted to concentrations from LoB to 4xLoB (1.05 - 6.16 ng/mL).
  • LoQ: 10 samples diluted to concentrations ranging from 1.0 to 10.0 ng/mL.
  • Data provenance not explicitly stated.
• Analytical Specificity (Endogenous Interference):
  • Two serum samples containing ferritin at ~82 ng/mL and ~445 ng/mL.
  • Data provenance not explicitly stated.
• Analytical Specificity (Antigen Excess / Prozone):
  • A set of 9 concentrations made by diluting analyte-spiked normal human serum (~80,000 ng/mL).
  • Data provenance not explicitly stated.
• Method Comparison:
  • 54 unaltered human serum samples (ferritin concentrations ranging from 5.9 to 994.4 ng/mL).
  • Data provenance not explicitly stated.
• Matrix Comparison (Serum vs. EDTA Plasma):
  • 65 matched serum and EDTA plasma patient samples (one sample spiked to extend range).
  • Data provenance not explicitly stated.
• Matrix Comparison (Serum vs. Heparin Plasma):
  • 59 matched serum and heparin plasma patient samples (14 samples spiked to extend range).
  • Data provenance not explicitly stated.

2. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The "ground truth" for the performance studies is based on the inherent analytical properties of the samples themselves and comparison to a referenced standard or predicate device, rather than expert interpretation of images or clinical cases.

3. Adjudication Method for the Test Set:

• Not applicable. As an IVD assay, the performance is assessed through quantitative measurements and statistical analysis against predefined analytical criteria and/or predicate device results. There is no human adjudication process involved in establishing the "ground truth" for these analytical measurements.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No. This is an in vitro diagnostic device for quantitative biomarker measurement. MRMC studies are typically used for imaging or diagnostic devices that involve human interpretation.

5. Standalone (Algorithm Only) Performance:

• Yes, implicitly. All described performance characteristics (precision, linearity, detection limits, analytical specificity, method comparison, matrix comparison) reflect the standalone performance of the K-ASSAY® Ferritin (2nd Gen.) assay on the Beckman/Olympus AU680 analyzer, without direct "human-in-the-loop" interaction for interpreting the results in these analytical performance studies. The output is a quantitative value, not an interpretation requiring a human reader.

6. Type of Ground Truth Used:

• Referenced Standards and Analytical Measurements:
  • For Traceability, the ground truth for calibrator values is established against the WHO 2nd International Ferritin Standard, lot 80/578.
  • For Precision, Linearity, and Detection Limits, the ground truth is based on the actual measured concentrations of analytes in well-characterized samples (e.g., controls, diluted samples, blank samples) and the statistical models used to derive these parameters according to CLSI guidelines.
  • For Analytical Specificity, the ground truth for interference studies is the known concentration of the interferent added to samples and the observed effect on ferritin measurement.
  • For Method Comparison, the ground truth is the result obtained from the predicate device (K-ASSAY® Ferritin (2) from K050944).
  • For Matrix Comparison, the ground truth for serum, EDTA plasma, and heparin plasma is the measured ferritin concentration in matched samples.

7. Sample Size for the Training Set:

• Not explicitly stated/Not applicable in the conventional sense. This is a chemical/immunological assay, not a machine learning or AI-based device that would typically have a "training set" for an algorithm. The development of reagents and optimization of the assay protocol would involve numerous experiments and adjustments, but these are not referred to as statistical "training sets" in this context.

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

• Not applicable. As explained above, this device does not utilize a training set in the machine learning sense. The assay principle is based on immunoturbidimetry, where the signal generated directly correlates with the ferritin concentration, using a calibration curve established with known calibrator concentrations traceable to an international standard.

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