(16 days)
The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.
The MMB Method for the Dimension® RxL Clinical Chemistry System is a one-step enzyme immunoassay based on the "sandwich" princible. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for the CKB subunit, and conjugate reagent (Bgalactosidase labeled monoclonal antibodies specific for CKMB isoenzyme). A particle-CKMB -coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with a chromogenic substrate chlorophen! red-ß-d-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of CKMB in the original sample.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device | Correlation coefficient of 0.998 |
| Acceptable slope relative to predicate device | Slope of 0.845 |
| Acceptable intercept relative to predicate device | Intercept of 0.496 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 137 clinical patient samples
- Data Provenance: The text states "clinical patient samples," implying human origin. It does not provide information about the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided in the text. The study compares the performance of the new device against a predicate device, which itself is an established method. The "ground truth" here is essentially the results generated by the predicate device.
4. Adjudication Method for the Test Set
- None. The comparison is a direct split-sample analysis between the new device and the predicate device. There is no mention of independent expert adjudication of results from either method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. This was not an MRMC study. The comparison was between two analytical methods, not involving human readers interpreting results in a diagnostic setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively. The study assesses the performance of the "MMB Method for the Dimension® RxL Clinical Chemistry System" as a standalone analytical device, comparing its output directly to an established predicate device. There is no human intervention mentioned in the measurement process itself that would alter the device's inherent performance.
7. The Type of Ground Truth Used
- Predicate Device Results: The "ground truth" for the comparison is established by the results obtained from the Abbott IMx® Stat CK-MB assay, which is the predicate device. The new device's performance is gauged by its concordance with this established method.
8. The Sample Size for the Training Set
- This information is not provided in the text. The document describes a validation study for the device, not the development or training of the assay itself.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the text, as no details about a training set are given.
§ 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.