(88 days)
The LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON® XL Analyzer.
The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay.
The LIAISON® N-TACT® PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Gen II assay.
The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples.
LIAISON® N-TACT® PTH Gen II Control set contains:
2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized
The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL.
The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set.
LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains:
4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL.
The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.
Here's an analysis of the acceptance criteria and study details for the LIAISON® N-TACT® PTH Gen II device based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The 510(k) summary for the LIAISON® N-TACT® PTH Gen II primarily demonstrates substantial equivalence to a predicate device. As such, the "acceptance criteria" are generally implied by the performance of the predicate device and the demonstration that the new device performs comparably or better, meeting established clinical laboratory guidelines. Specific numeric acceptance criteria are not explicitly stated in a "PASS/FAIL" format for each performance characteristic, but rather the study results are presented to show satisfactory performance.
Here's a table summarizing the performance characteristics and their reported results, which implicitly serve as the demonstration of meeting acceptance:
| Performance Characteristic | Acceptance Criteria (Implied / Predicate Performance) | Reported Device Performance (LIAISON® N-TACT® PTH Gen II) |
|---|---|---|
| Method Comparison (vs. Predicate) | Substantial equivalence to Siemens ADVIA® CENTAUR INTACT iPTH (K020217) | n=198 |
| Slope: 1.010 (95% CI: 0.99 to 1.03) | ||
| Intercept: -1.5851 pg/mL (95% CI: -3.11 to -0.44) | ||
| Correlation coefficient (r): 0.9953 | ||
| Measuring Range | Comparable to predicate (2.5 - 1900 pg/mL) | 3 - 1900 pg/mL |
| Sample Matrix Equivalence | Equivalent results across EDTA plasma, serum, SST serum, Lithium Heparin plasma | EDTA plasma vs. Serum: Slope 0.97, Int. -2.45, R² 0.9986 |
| EDTA plasma vs. SST Serum: Slope 1.01, Int. -2.25, R² 0.9996 | ||
| EDTA plasma vs. Lithium Heparin: Slope 0.98, Int. -0.01, R² 0.9991 | ||
| Reference Range | Established and clinically appropriate | 14.5 - 87.1 pg/mL (n=125 healthy adults from US) |
| Precision | Demonstrated by low %CVs across various PTH levels (following CLSI EP5-A2) | Total %CVs across lots (selected examples): |
| 19.3 pg/mL: 3.3% | ||
| 250 pg/mL: 3.5% | ||
| 12.6 pg/mL: 4.2% | ||
| 1477 pg/mL: 2.8% | ||
| Linearity | Linear response across the assay range (following CLSI EP6-A) | R² for various matrices: Serum: 0.9982, SST Serum: 0.9987, EDTA plasma: 0.9983, Lithium Heparin plasma: 0.9992 (all close to 1, indicating linearity) |
| High Dose Hook Effect | No hook effect within a specified range | No hook effect observed up to 1,000,000 pg/mL of PTH |
| Recovery | Acceptable percentage recovery values | Mean Recovery: 97% (range 93%-103% across various spiked samples) |
| Analytical Specificity (Cross-Reactivity) | Minimal cross-reactivity with related substances | PTH (7-84): 53% |
| Other PTH fragments, Calcitonin, C-Telopeptide, Osteocalcin: |
§ 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.