(199 days)
ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of the levels of parathyroid hormone in human serum and EDTA plasma on specific TOSOH AIA System analyzers. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
The ST AIA-PACK Intact PTH CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK Intact PTH.
The AIA-PACK Intact PTH CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Intact PTH Assay.
The ST AIA-PACK Intact PTH is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK Intact PTH present in the test sample is bound with polyclonal antibody immobilized on magnetic beads and enzyme-labeled polyclonal antibody in the AIA- PACK. The magnetic beads are washed to remove unbound enzyme-labeled polyclonal antibody and are then incubated with a fluorogenic substrate 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled polyclonal antibody that binds to the beads is directly proportional to Intact PTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The Tosoh Bioscience, Inc.'s ST AIA-PACK Intact PTH Assay is designed for the quantitative measurement of Intact Parathyroid Hormone (Intact PTH) in human serum and EDTA plasma. This device is intended for in vitro diagnostic use for the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" as a separate section with specific numerical targets. However, the performance characteristics presented demonstrate the device's capabilities and its substantial equivalence to the predicate device. For the purpose of this response, reported performance characteristics are presented below in a table format.
| Parameter | Acceptance Criteria (Inferred from Predicate/Performance) | Reported Device Performance (ST AIA-PACK Intact PTH) |
|---|---|---|
| Limit of Detection | Approximately 1.20 pg/ml (Predicate) | ≈1.0 pg/ml |
| Assay Range | Not explicitly stated for predicate in provided text | 1 - 2200 pg/ml |
| Total Precision (CV%) | Not explicitly stated for predicate in provided text | Serum A3: 3.6% |
| Serum B3: 3.7% | ||
| Serum C3: 4.0% | ||
| Plasma A3: 4.9% | ||
| Plasma B3: 4.7% | ||
| Plasma C3: 3.6% | ||
| Correlation (R value) | Not explicitly stated for predicate in provided text | 0.997 (against predicate) |
| Recovery (%) - Mean | Not explicitly stated | ~98.1 - 109.0% range across samples |
| Endogenous Substance Interference | Recovery within ±10% of known mean concentration | Hemoglobin (up to 440 mg/dL), free bilirubin (up to 17 mg/dL), and conjugated bilirubin (up to 17 mg/dL) do not interfere |
| Normal Range | 15 – 65 pg/ml (Predicate) | 8.2 – 83.5 pg/ml |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- Correlation Study: 153 samples were used to establish the correlation with the predicate device.
- Precision Study: For each of the six samples (Serum A3, B3, C3, Plasma A3, B3, C3), multiple measurements would have been taken to calculate the mean, standard deviation, and CV%. The exact number of replicates per sample is not specified, but typically requires a minimum of 20 replicates for precision studies.
- Recovery Study: The report indicates three measurements for each of the six samples (Serum A1, B1, C1, Plasma A1, B1, C1).
- Interference Study: The number of samples for interference testing is not explicitly stated, but it involved testing various concentrations of hemoglobin, free bilirubin, and conjugated bilirubin.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI/radiology imaging device requiring expert ground truth for interpretation. The ground truth for this device is based on analytical measurements and comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set:
Not applicable, for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic imaging device meant to improve human reader performance. It is a standalone in vitro diagnostic assay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the device performance characteristics, such as Limit of Detection, Assay Range, Total Precision, Correlation, Recovery, and Endogenous Substance Interference, are all measures of the device's standalone analytical performance. The study demonstrates the intrinsic performance of the assay without direct human intervention in the measurement process (beyond operating the instrument and preparing samples).
7. Type of Ground Truth Used:
The ground truth for evaluating the ST AIA-PACK Intact PTH assay relied on:
- Analytical Standards/Known Concentrations: For parameters like Limit of Detection, Assay Range, and Recovery, the device's performance is assessed against samples with known, established concentrations of Intact PTH.
- Comparison to a Predicate Device: For the correlation study, the results from the ST AIA-PACK Intact PTH assay were compared to those obtained from the Roche Diagnostics Corp., Elecsys Parathyroid Hormone Test System (K992680), which serves as the "ground truth" or reference method for comparison.
- Interference Testing: Known concentrations of interfering substances added to samples with known Intact PTH levels were used to assess the impact.
8. Sample Size for the Training Set:
Not applicable. This is a biochemical assay, not an AI model that requires a "training set" in the machine learning sense. The device's operational parameters and calibration are established through standard laboratory procedures and physical/chemical principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of developing this type of in vitro diagnostic device. The assay performs measurements based on a chemical reaction and fluorescent detection. Calibration is performed using the ST AIA-PACK Intact PTH CALIBRATOR SET, which would have established values traceable to reference materials.
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.