(69 days)
System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma on Olympus analyzers.
Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
In this Olympus procedure: The R1 reagent antibody binds to the M subunit of CK in the serum sample. The B subunit of the enzyme acts on the substrate present in the R2 reagent. CK reversibly catalyzes the transfer of a phosphate group from creatine phosphate to ADP to give creatine and ATP. The ATP is used to produce glucose-6-phosphate and ADP, catalyzed by hexokinase (HK) which requires magnesium ions for maximum activity. The glucose-6-phosphate is oxidized by the action of the enzyme G6P-DH with simultaneous reduction of the coenzyme NADP to give NADPH and 6-phosphogluconate. The rate of increase of absorbance at 340/660 nm due to the formation of NADPH is directly proportional to the activity of CK-MB in the sample.
Here's an analysis of the provided text regarding the Olympus CK-MB Reagent (OSR6x155), focusing on the acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document compares the new Olympus CK-MB (OSR6x155) reagent with a predicate device (Olympus CK-MB OSR6x53). While explicit "acceptance criteria" for performance are not directly stated in the format of a threshold to be met, the comparison with the predicate device implies that performance similar to or better than the predicate is the acceptance standard.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Olympus CK-MB OSR6x155) |
|---|---|---|
| Precision (Total CV%) | ||
| AU400/400e | ||
| Sample 1 | Predicate: 2.85% | 4.26% |
| Sample 2 | Predicate: 0.65% | 1.31% |
| Sample 3 | Predicate: 0.52% | 1.10% |
| AU600/640/640e | ||
| Sample 1 | Predicate: 9.12% | 5.05% |
| AU2700/5400 | ||
| Sample 1 | Predicate: 5.59% | 3.50% |
| Sample 2 | Predicate: 3.54% | 1.13% |
| Sample 3 | Predicate: 3.76% | 1.21% |
| Assay Range | 10 to 2000 U/L | 10 to 2000 U/L |
| Sensitivity | Predicate: ~0.08 mAbsorbance per 1 U/L | ~0.12 mAbsorbance per 1 U/L |
| Method Comparison (Linear Regression) | ||
| Intercept | Predicate: 2.700 | 2.207 |
| Slope | Predicate: 0.965 | 1.061 |
| R2 | Predicate: 1.000 | 1.000 |
| Range | Predicate: 2-1881 U/L | 12-1860 U/L |
| Interfering Substances (Bilirubin) | ||
| AU600/640/640e | Predicate: |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.