(55 days)
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in human serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes.
The provided text describes the performance of the Bayer ADVIA® 1650 Chemistry System for 21 different clinical methods, comparing it to predicate devices. Each method has its own set of performance data. Since the request asks for a table of acceptance criteria and reported device performance, and the provided text does not explicitly state acceptance criteria in a dedicated section (but rather reports performance metrics meant to demonstrate equivalence), I will interpret "acceptance criteria" as the performance levels observed in the predicate devices where available, or industry-standard expectations for such devices. The "reported device performance" will be the data presented for the ADVIA 1650.
Due to the length and detail of the provided text covering 21 methods, I will focus on a subset of the methods (Albumin, ALP-AMP, Amylase, AST, Calcium) to illustrate the acceptance criteria and device performance based on the information provided. The remaining methods follow a similar pattern of data presentation.
1. Table of Acceptance Criteria and Reported Device Performance
For each analyte, the acceptance criteria are implicitly set by the performance of the predicate devices or by general expectations for clinical chemistry analyzers (e.g., strong correlation, low imprecision, minimal interference). The reported device performance is explicitly stated for the ADVIA 1650.
Here's an example for a few selected methods:
| Method (Analyte) | Performance Metric | Acceptance Criteria (from Predicate/Expectation) | Reported Device Performance (ADVIA 1650) |
|---|---|---|---|
| Albumin | Total CV (%) - Low level serum | 0.95 expected | 0.969 (DAX), 0.978 (Plasma vs. Serum) |
| Interfering Subs. (Bilirubin 25mg/dL) effect on 4.2 g/dL (%) | Minimal ( 0.95 expected | 0.999 (DAX), 0.972 (Plasma vs. Serum) | |
| Interfering Subs. (Bilirubin 25mg/dL) effect on 69.3 U/L (%) | Minimal ( 0.95 expected | 0.998 (CX4), 0.985 (Plasma vs. Serum), 0.993 (CX7 Urine) | |
| Interfering Subs. (Bilirubin 25mg/dL) effect on 68.3 U/L (%) | Minimal ( 0.95 expected | 0.999 (DAX), 0.954 (Plasma vs. Serum) | |
| Interfering Subs. (Bilirubin 25mg/dL) effect on 31.0 U/L (%) | Minimal ( 0.95 expected | 0.971 (DAX), 0.963 (Plasma vs. Serum), 0.999 (Dimension Urine), 0.988 (CX3 Urine) | |
| Interfering Subs. (Bilirubin 25mg/dL) effect on 8.0 mg/dL (%) | Minimal ( |
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.