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For in vitro diagnostic use.
Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following:

1. Antibody-Coated Particle Solution (Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300
2. Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300

Here's a breakdown of the acceptance criteria and the study details for the Lumipulse G whole PTH device, based on the provided FDA 510(k) summary:

Device: Lumipulse G whole PTH (Fujirebio Diagnostics, Inc.)
Intended Use: Quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System for differential diagnosis of hypercalcemia and hypocalcemia.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various analytical performance characteristics. For each characteristic, the reported performance is presented. Acceptance criteria are generally implied by the positive outcomes of the studies and their adherence to CLSI guidelines. For example, for precision, a certain percentage of Coefficient of Variation (%CV) is considered acceptable.

2. Sample Size and Data Provenance (for test set/performance studies)

The document refers to various samples for different analytical studies:

• 20-Day Precision: A panel of seven native human serum samples (n=80 replicates for each sample). The study was conducted at an internal laboratory. Origin of samples is "native human serum" but specific country/retrospective/prospective nature is not specified beyond that.
• Lot-to-Lot Precision: A panel of four native human serum samples and two control levels (n=32 replicates per lot, 96 total replicates per sample/control across three lots). Internal laboratory. "Native human serum" for samples.
• Site-to-Site Precision: A panel of five native serum samples (n=combined data for site-to-site analysis). Internal laboratory and two additional sites. "Native serum" for samples.
• Linearity: High and low sample pools created using patient serum samples that contained naturally expressed whole PTH. Specific number of samples not detailed, but the linearity range was derived from these pools.
• Detection Limit (LoB, LoD, LoQ): Four blank and four low-level serum specimens (LoB/LoD: 60 determinations for each panel per lot); five low-level serum (LoQ: on 2 systems with 2 lots across several days).
• Analytical Specificity/Cross Reactivity: A panel of serum samples with naturally occurring whole PTH (n=4 panel members) for cross-reactivity with 10 different substances.
• Interfering Substances: Human serum specimen pools with whole PTH concentrations of approximately 35.1, 81.5, and 235.9 pg/mL.
• Matrix Comparison: Seventy-one (71) matched sets of serum and plasma samples.
• Method Comparison: A total of 275 matched human serum samples.
• Expected Values/Reference Range: 147 serum specimens from an "apparently healthy adult population (22-72 years old)."

Data Provenance Remarks:

• All studies mentioned use "native human serum" or "patient serum samples," indicating biological samples.
• Studies were conducted at "internal laboratory" and "two additional sites," suggesting multi-site evaluation for some parameters.
• The document does not explicitly state geographical origin (e.g., country) or whether samples were retrospective or prospectively collected for most analytical studies. The "apparently healthy adult population" for expected values implies a specific collection for that purpose.

3. Number of Experts and Qualifications for Ground Truth

• The document is for an in vitro diagnostic (IVD) device that measures a biomarker (PTH). The ground truth for such devices is typically established by reference methods, defined concentrations, or clinically characterized samples.
• Therefore, no "experts" (e.g., radiologists) are explicitly mentioned or required to establish a ground truth for diagnostic imaging interpretation, as this is not an imaging device.
• The ground truth for the analytical studies comes from:
  • Known concentrations: For calibrators, controls, and spiked samples (e.g., linearity, detection limits, cross-reactivity, interfering substances).
  • Clinical characterization: For "native human serum" samples, their PTH levels are measured.
  • International standards: Traceability of calibration is to the 1st international standard for Parathyroid Hormone 1-84 (code: 95/646) provided by the NIBSC.

4. Adjudication Method for the Test Set

• Not applicable. This section typically applies to diagnostic imaging studies where expert readers adjudicate findings. For an IVD device measuring a biomarker, the "ground truth" is determined by the analytical measurement process itself using established methods, standards, and controls.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for diagnostic imaging AI, where multiple human readers interpret cases with and without AI assistance. This device is an in vitro diagnostic for quantitative measurement of a biomarker and does not involve human readers interpreting images.

6. Standalone Performance Study

• Yes, for the device itself. All the analytical performance studies (precision, linearity, detection limits, specificity, interference, specimen stability, matrix comparison) described are studies of the Lumipulse G whole PTH device operating in a standalone mode (i.e., the algorithm/assay system without human-in-the-loop performance influencing the measurement output directly).
• The Method Comparison study directly compares the standalone performance of the Lumipulse G whole PTH to a legally marketed predicate device (LIAISON® 1-84 PTH Assay), which also measures PTH quantitatively without human interpretation within the measurement process.

7. Type of Ground Truth Used

The ground truth for the performance studies is established by:

• Reference Materials/International Standards: Calibration is traceable to the 1st international standard for Parathyroid Hormone 1-84 (code: 95/646) provided by the National Institute for Biological Standards and Controls (NIBSC).
• Spiked Samples/Known Concentrations: For studies like linearity, detection limits, cross-reactivity, interfering substances, where specific amounts of analyte or interfering substances are added to samples.
• Clinically Characterized Patient Samples: "Native human serum" or "patient serum samples" are used, with their PTH levels being the "truth" for evaluation against expected performance or comparison with other methods.
• Predicate Device Comparison: For the method comparison study, the results from the legally marketed predicate device (LIAISON® 1-84 PTH Assay) serve as a comparative "ground truth" or reference for evaluating substantial equivalence.

8. Sample Size for the Training Set

• The document does not provide information on a specific "training set" sample size. This submission is for an IVD assay, not typically a machine learning or AI algorithm that undergoes explicit "training" as defined in the context of imaging AI.
• For IVD assays, method development and optimization phases internally use numerous samples, but these are generally considered part of the product development, not a formal "training set" like in AI. The studies presented here are for validation and verification of the developed assay.

9. How Ground Truth for the Training Set Was Established

• Not applicable in the context of an IVD assay as presented. As explained above, there isn't a "training set" in the common AI/ML sense.
• Ground truth for assay development and optimization (analogous to "training" in a broad sense) would rely on the same principles as the validation studies: known concentrations, reference materials, and clinically characterized samples.

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