(106 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 serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes.
The Bayer ADVIA® 1650 Chemistry System is an automated, clinical chemistry analyzer designed to measure various analytes in human serum, plasma, or urine. The 510(k) submission (K990346) provides performance data for 21 clinical methods, comparing the ADVIA 1650 to predicate devices. This response focuses on the Albumin method as a representative example, as the provided text doesn't explicitly state acceptance criteria in a unified table but rather presents performance characteristics individually for each assay.
1. Table of Acceptance Criteria and Reported Device Performance (Albumin Method)
Since explicit acceptance criteria are not provided, we infer performance metrics based on the comparison with predicate devices and typical clinical laboratory standards. The performance metrics presented below are those reported for the ADVIA 1650 and its predicate device (Technicon DAX) for Albumin, as detailed in the submission.
| Performance Metric | Acceptance Criteria (Inferred/Typical) | ADVIA 1650 Performance | Predicate Device Performance (Technicon DAX) |
|---|---|---|---|
| Imprecision (Total CV %) | |||
| Serum (Level 1: ~2.1-2.2 g/dL) | Typically 0.95 (commonly accepted standard) | 0.969 (Serum: MSK) | N/A |
| Correlation to Predicate (Syx - Std Error of Estimate) | Close to 0, indicating strong agreement | 0.19 (Serum: MSK) | N/A |
| Regression Equation (Slope) | Close to 1 (indicating proportional agreement) | 0.86 (Serum: MSK) | N/A |
| Regression Equation (Y-intercept) | Close to 0 (indicating absence of constant bias) | 0.55 (Serum: MSK) | N/A |
| Interfering Substances (Effect %) | Generally |
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.