(50 days)
The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.
The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.
The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.
Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA® 1650™ Acid Phosphatase assay, based on the provided text:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Imprecision (Total ACP) | Sufficiently low CV to ensure reliable results (no explicit criteria stated, but expected to be within industry standards for clinical assays). | Level 1 (18.39 U/L): Within-Run CV: 3.0%, Total CV: 9.2% |
| Level 2 (36.98 U/L): Within-Run CV: 2.2%, Total CV: 4.0% | ||
| Level 3 (42.23 U/L): Within-Run CV: 1.9%, Total CV: 3.8% | ||
| Imprecision (NpACP) | Sufficiently low CV to ensure reliable results (no explicit criteria stated). | Level 1 (10.01 U/L): Within-Run CV: 6.2%, Total CV: 9.2% |
| Level 2 (24.50 U/L): Within-Run CV: 3.4%, Total CV: 4.8% | ||
| Level 3 (28.88 U/L): Within-Run CV: 5.1%, Total CV: 7.0% | ||
| Correlation (NpACP) | Strong correlation with predicate device (e.g., R-value > 0.95, slope near 1, intercept near 0, given the stated bias). | N = 64, Regression Equation: Y = 0.82x + 1.8, Syx = 2.56, R = 0.987. |
| 95% CI for slope: 0.787 to 0.856 | ||
| 95% CI for intercept: 0.793 to 2.811 | ||
| Correlation (Total ACP) | Strong correlation with predicate device (e.g., R-value > 0.95, slope near 1, intercept near 0, given the stated bias). | N = 71, Regression Equation: Y = 0.76x + 0.91, Syx = 1.95, R = 0.993. |
| 95% CI for slope: 0.7345 to 0.7781 | ||
| 95% CI for intercept: 0.189 to 1.627 | ||
| Interfering Substances | Insignificant interference (e.g., % change within an acceptable clinical limit, typically |
§ 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.