(140 days)
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
The Access Intact PTH reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of intact parathyroid hormone (PTH) levels in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access Intact PTH and Intact PTH Calibrators on the Access® Immunoassay Systems, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Imprecision (CV%) | Not explicitly stated | Routine Mode: 2.8% to 6.4% CV (for 12-1400 pg/mL) |
| Intraoperative Mode: 3.1% to 10.6% CV (for 12-1400 pg/mL) | ||
| Dilution Recovery (Linearity) | Not explicitly stated | Routine Mode: Mean % recovery 91% to 103% |
| Intraoperative Mode: Mean % recovery 85% to 98% | ||
| Methods Comparison (Routine vs. Predicate) | Not explicitly stated | Range: 16-2627 pg/mL |
| Intercept: -11.5 pg/mL | ||
| Slope: 1.09 | ||
| Correlation Coefficient (r): 0.99 | ||
| Methods Comparison (Routine vs. Intraoperative) | Not explicitly stated | Range: 13-2848 pg/mL |
| Intercept: 9.69 pg/mL | ||
| Slope: 0.94 | ||
| Correlation Coefficient (r): 1.00 | ||
| Methods Comparison (Intraoperative vs. Predicate) | Not explicitly stated | Range: 8-2453 pg/mL |
| Intercept: 0.13 pg/mL | ||
| Slope: 0.87 | ||
| Correlation Coefficient (r): 1.00 | ||
| Analytical Specificity | No significant interference | No significant interference from bilirubin, hemoglobin, human serum albumin, and triglycerides. |
| Stability (Reagents) | Not explicitly stated | 28 days after opening |
| Stability (Calibrators) | Not explicitly stated | Single use only, calibration stable for 28 days |
| Clinical Reference Range | Not explicitly stated | 12-88 pg/mL (95% non-parametric reference interval) |
*Note: The acceptance criteria are "implied" as specific thresholds were not explicitly stated in the 510(k) summary (e.g., "CV must be
§ 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.