(120 days)
Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.
Here's a breakdown of the acceptance criteria and study information for the Dri-STAT® ACP Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in the typical sense of threshold values (e.g., "r-value > 0.95"). Instead, it presents performance data for method comparison and imprecision. The implicit acceptance criterion is that the performance of the candidate device (Dri-STAT® ACP Reagent on Synchron Systems) is substantially equivalent to the predicate device (Dri-STAT® ACP Reagent on Cobas Fara). Substantial equivalence is demonstrated through the presented performance data.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Dri-STAT® ACP Reagent on Synchron Systems) |
|---|---|---|
| Method Comparison | Substantially equivalent to predicate device (Dri-STAT® ACP on Cobas Fara) | |
| TACP (Synchron LX) | High correlation (R) and reasonable slope/intercept | Slope: 1.093, Intercept: 0.143, R: 0.994 (n=94) |
| NPAP (Synchron LX) | High correlation (R) and reasonable slope/intercept | Slope: 1.066, Intercept: -0.197, R: 0.979 (n=47) |
| TACP (Synchron CX) | High correlation (R) and reasonable slope/intercept | Slope: 1.075, Intercept: 0.460, R: 0.997 (n=94) |
| NPAP (Synchron CX) | High correlation (R) and reasonable slope/intercept | Slope: 1.088, Intercept: -0.172, R: 0.994 (n=47) |
| Imprecision (TACP) | Low coefficient of variation (%C.V.) for controls and human pool | |
| Within-Run (Control 1) | Not specified explicitly, but generally |
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.