(165 days)
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:
- 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
- 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.
| Acceptance Criteria Category | Specific Metric / Study | Reported Device Performance (Lumipulse G whole PTH) |
|---|---|---|
| Analytical Precision | 20-Day Precision (Total %CV) | ≤ 4% (e.g., Control Level 1: 3%, Serum 7: 3%) |
| Lot-to-Lot Precision (Inter-lot %CV) | ≤ 4% (e.g., Control Level 1: 4%, Serum 4: 3%) | |
| Site-to-Site Precision (Total %CV) | ≤ 6.7% (e.g., Serum 1: 6.3%, Serum 2: 6.7%) | |
| Linearity/Reportable Range | Linearity Range (Correlation R²) | 1.4 pg/mL - 2190.3 pg/mL (R²=0.9984) |
| Measuring Range | 4.0 pg/mL - 1800.0 pg/mL | |
| Detection Limits | Limit of Blank (LoB) | 0.0 pg/mL |
| Limit of Detection (LoD) | 0.295 pg/mL | |
| Limit of Quantitation (LoQ) | 2.128 pg/mL (defined as interassay CV of 10%) | |
| Analytical Specificity/Cross-Reactivity | Cross-Reactivity with specified substances (e.g., Calcitonin, PTH fragments) |
§ 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.