(176 days)
The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
The provided text describes the ATAC Calcium Reagent Kit and studies demonstrating its performance. However, it does not explicitly define "acceptance criteria" as a set of specific thresholds for the reported performance metrics. Instead, it presents the results of various validation studies and implicitly suggests that these results are deemed acceptable for the device's intended use and demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, framed to address your request for acceptance criteria and the supporting study, even if the "acceptance criteria" are implied rather than explicitly stated.
Interpretation of Acceptance Criteria:
Given that this is a 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to a predicate device (HiChem™ Calcium Reagent Kit) and proving that the device performs safely and effectively for its intended use. While explicit numerical cut-offs aren't listed as "acceptance criteria," the reported performance metrics in the studies are implicitly deemed acceptable by the manufacturer for this purpose.
1. Table of Acceptance Criteria and Reported Device Performance
Note: As explicit "acceptance criteria" are not provided, the table below lists the performance parameters evaluated and their reported results. The implied acceptance is that these results are clinically acceptable and demonstrate substantial equivalence to the predicate device.
| Performance Parameter | Implied Acceptance Criteria (based on common IVD standards and predicate equivalence) | Reported Device Performance (ATAC Calcium Reagent Kit) |
|---|---|---|
| Linearity/Recovery | Demonstrated linearity across the usable range; high correlation (r > 0.99) | Linear from 0.2 to 15 mg/dL; r = 0.9984; (ATAC Recoveries) = 1.069 x (Standard Value); sy.x = 0.32 mg/dL; n = 21 (for regression) |
| Precision (Within Run) | Low %CV for different serum levels (e.g., 0.95) and good agreement with a predicate or established method | ATAC 8000 = 0.7 mg/dL + 0.944 x Competitive Reagent; r = 0.942; n = 120; range = 6.4 - 11.5 mg/dL |
| Detection Limit | Ability to detect low clinically relevant concentrations | 0.2 mg/dL (documented by repetitive assay of a diluted serum pool; SD of 30 replicates was 0.05 mg/dL) |
| Reagent Stability (On-board) | Demonstrated stability for claimed period; imprecision within acceptable limits | 14-day stability documented; total imprecision of calcium recoveries over test period was |
§ 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.