(85 days)
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
The Randox Calcium (Ca) device is an in vitro diagnostic intended for the quantitative determination of calcium concentration in serum, plasma, and urine on the RX series analyzer RX daytona plus. The device demonstrates substantial equivalence to the predicate device, the ADVIA Chemistry Calcium_2 (CA_2) Method (K083386), based on performance characteristics including precision, linearity, analytical specificity, and method comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from validation studies) | Reported Device Performance (Randox Calcium (Ca)) |
|---|---|---|
| Precision (Serum) | Total CV% for Serum: | Lot 1: Level 1: 4.1%, Level 2: 3.6%, Level 3: 3.7%, Level 4: 3.7% |
| - Level 1: ≤ 4.2% (based on predicate value) | Lot 2: Level 1: 4.2%, Level 2: 4.2%, Level 3: 4.1%, Level 4: 4.0% | |
| - Level 2: ≤ 4.2% (based on predicate value) | ||
| - Level 3: ≤ 4.1% (based on predicate value) | ||
| - Level 4: ≤ 4.0% (based on predicate value) | ||
| Precision (Urine) | Total CV% for Urine: | Lot 1: Level 1: 4.6%, Level 2: 4.0%, Level 3: 4.0%, Level 4: 3.9% |
| - Level 1: ≤ 4.0% (based on predicate value) | Lot 2: Level 1: 4.0%, Level 2: 4.1%, Level 3: 4.0%, Level 4: 3.7% | |
| - Level 2: ≤ 4.1% (based on predicate value) | ||
| - Level 3: ≤ 4.0% (based on predicate value) | ||
| - Level 4: ≤ 3.7% (based on predicate value) | ||
| Linearity (Serum) | Correlation Coefficient r ≥ 0.99 | Lot 1: r = 1.00; Lot 2: r = 1.00 |
| Reportable Range: 1.0 - 16 mg/dL | Lot 1: 1.0 - 16 mg/dL; Lot 2: 1.0 - 16 mg/dL | |
| Linearity (Urine) | Correlation Coefficient r ≥ 0.99 | Lot 1: r = 1.00; Lot 2: r = 1.00 |
| Reportable Range: 1.0 - 32 mg/dL | Lot 1: 1.0 - 32 mg/dL; Lot 2: 1.0 - 32 mg/dL | |
| Analytical Specificity | Deviation from control |
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.