(146 days)
The Nichols Advantage® Bio-Intact PTH (1-84) Immunoassay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum, EDTA plasma and heparinized 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. Measurements of parathyroid hormone levels with the Bio-Intact PTH (1-84) Immunoassay are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
The Bio-Intact PTH (1-84) Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.
Here's a summary of the acceptance criteria and study information for the Nichols Advantage® Bio-Intact PTH (1-84) Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes the device as a modification of a predicate device (K013992). The acceptance criteria are implicit in the comparison to the predicate device and the reported performance characteristics.
| Feature | Acceptance Criteria (Predicate K013992) | Reported Device Performance (Modified Bio-Intact PTH (1-84) Assay) |
|---|---|---|
| Precision | ||
| Within Run CV | Not greater than 4% at dose > 5 pg/mL | Not greater than 6% at a dose > 5 pg/mL |
| Total CV | Not greater than 9.5% at dose > 34 pg/mL | Not greater than 11% at a dose > 5 pg/mL |
| Method Comparison 1 (Serum Analysis) | ||
| Sample Size | 305 | 305 |
| Range of Results | Nichols Advantage Intact PTH Assay: 5.0 to 1387 pg/mL | |
| Bio-Intact PTH (1-84) Assay: 3.0 to 746 pg/mL | Nichols Advantage Intact PTH Assay: 5.0 to 1387 pg/mL | |
| Bio-Intact PTH (1-84) Assay: 3.0 to 746 pg/mL | ||
| Passing Bablok Regression Equation | y = 0.66x - 0.6 | y = 0.66x - 0.6 |
| Least Squares Linear Regression Equation | y = 0.60x + 4.2 | y = 0.60x + 4.2 |
| Pearson's Correlation Coefficient (r) | 0.97 | 0.97 |
| Method Comparison 2 (Renal Dialysis Samples) | N/A | |
| Sample Size | N/A | 3187 |
| Range of Results | N/A | Nichols Advantage Intact PTH Assay: 7 - 1797 pg/mL |
| Bio-Intact PTH (1-84) Assay: 4 - 998 | ||
| Least Squares Linear Regression Equation | N/A | Y = 0.52x + 1.3 |
| Pearson's Correlation Coefficient (r) | N/A | 0.97 |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison 1 (Serum Analysis):
- Sample Size: 305
- Data Provenance: Not explicitly stated, but clinical samples are implied for method comparison. The text does not specify country of origin or if prospective/retrospective.
- Method Comparison 2 (Renal Dialysis Samples):
- Sample Size: 3187
- Data Provenance: Not explicitly stated. Clinical samples from renal dialysis patients are implied. The text does not specify country of origin or if prospective/retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is an in vitro diagnostic (IVD) immunoassay. The concept of "experts" establishing ground truth as in imaging or clinical diagnosis is not directly applicable. The ground truth for method comparison studies in IVDs is typically established by the predicate device or a reference method. In this case, the Nichols Advantage Intact PTH Assay (the predicate device, K013992) served as the comparator for method comparison studies.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD immunoassay study. The comparison is quantitative against a predicate device.
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
Not applicable. This is an immunoassay, not an imaging or interpretive device that involves human "readers" or "AI assistance."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a standalone algorithm/device. Its performance is measured directly by its ability to quantify PTH levels in biological samples. It operates without human interpretive input in the measurement process itself, although clinical interpretation of results requires a human. The performance metrics (precision, method comparison) are standalone device metrics.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence and performance characteristics was established by:
- Quantitative values obtained from the predicate device: The Nichols Advantage Intact PTH Assay was used as the comparator for the method comparison studies.
- Established analytical methods: Precision, sensitivity, linearity, etc., are measured against established performance specifications for immunoassays.
8. The Sample Size for the Training Set
The provided text only details the performance studies for the modified device. It does not contain information about a separate "training set" for an algorithm in the way machine learning models would have one. For an immunoassay, method development and optimization would involve numerous samples, but these are not typically reported as a "training set" in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" with established ground truth as in machine learning does not directly apply to this immunoassay submission. Assay development and validation would rely on known control materials, spiked samples, and comparison to established reference methods or predicate devices during the R&D phase to optimize assay parameters.
§ 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.