(69 days)
HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine. 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).
The HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.
Here's a breakdown of the acceptance criteria and study information for the HiChem Calcium Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided text describes two main scenarios for the HiChem Calcium Reagent: the manual procedure and its use on the Beckman® SYNCHRON CX® Systems (secondary reagent application). The acceptance criteria are largely implied by the reported performance, as the study aims to demonstrate substantial equivalence to an existing predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Performance Measure | Acceptance Criteria (Implied) | HiChem Calcium Reagent (Manual Procedure) Reported Performance | HiChem Calcium Reagent (SYNCHRON CX® Systems) Reported Performance |
|---|---|---|---|
| Linearity | Demonstrate linearity over a specific range. | Linear between 0.1 to 16 mg/dL. Regression: (HiChem) = -0.1 + 0.980 x (Standard Conc.), r² = 1.000, sy.x = 0.14 mg/dL. | Linear from at least 2.0 mg/dL to 15.0 mg/dL. Regression: (HiChem) = 0.0 + 0.967 x (Standard Conc.), r² = 1.000, sy.x = 0.08 mg/dL. |
| Precision | Meet specified SD for various control levels. | Serum Control 1 (6.69 mg/dL): within-run SD 0.21 mg/dL, total SD 0.24 mg/dL | |
| Serum Control 2 (12.68 mg/dL): within-run SD 0.29 mg/dL, total SD 0.30 mg/dL | |||
| Urine Pool 1 (2.41 mg/dL): within-run SD 0.11 mg/dL, total SD 0.11 mg/dL | |||
| Urine Pool 2 (11.10 mg/dL): within-run SD 0.13 mg/dL, total SD 0.16 mg/dL | Serum Control 1 (6.89 mg/dL): within-run SD 0.056 mg/dL, total SD 0.064 mg/dL | ||
| Serum Control 2 (10.03 mg/dL): within-run SD 0.085 mg/dL, total SD 0.089 mg/dL | |||
| Serum Control 3 (13.21 mg/dL): within-run SD 0.088 mg/dL, total SD 0.090 mg/dL | |||
| Urine Pool 1 (3.24 mg/dL): within-run SD 0.048 mg/dL, total SD 0.059 mg/dL | |||
| Urine Pool 2 (11.64 mg/dL): within-run SD 0.075 mg/dL, total SD 0.095 mg/dL | |||
| Method Comparison (Serum/Plasma) | Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent. | n=92. Regression: (HiChem) = -0.3 + 1.020 × (BMD® Results), r² = 0.887, s(y.x) = 0.21 mg/dL. | n=153. Regression: (HiChem) = -0.3 + 1.005 x (Beckman® Results), r² = 0.924, s(y.x) = 0.20 mg/dL. |
| Method Comparison (Urine) | Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent. | Regression: (HiChem) = 0.2 + 1.022 × (BMD® Results), r² = 0.998, s(y.x) = 0.15 mg/dL. | Regression: (HiChem) = 0.1 + 1.031 x (Beckman® Results), r² = 0.996, s(y.x) = 0.16 mg/dL. |
| Chemical Additives (Interference) | Biases less than a specified threshold (e.g., |
§ 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.