(263 days)
Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.
Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
Dimension Vista® MMB Assay:
The MMB method is a homogeneous sandwich chemiluminescent immunoassay based on LOCI® technology. LOC10 reagents include two synthetic bead reagents and a biotinylated antimass creatine kinase MB isoenzvme monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-mass creatine kinase MB isoenzyme monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmass creatine kinase MB isoenzyme-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the mass creatine kinase MB isoenzyme concentration in the sample.
The Dimension Vista® 1500 System:
The Dimension Vista® 1500 System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Flex reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension Vista® 1500 System can analyze up to 1500 tests/hour (typical, depending on the method mix) using a variety of analytical detection capabilities. Dimension Vista® 1500 System detection technologies are: Photometric, Turbidimetric, Chemiluminescent, Nephelometric, Multisensor, ion selective technology
The Siemens Healthcare Diagnostics Dimension Vista® MMB Assay is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma for confirmation of acute myocardial infarction. The K143720 submission describes the modification of the Dimension Vista® 1500 System with a new photomultiplier tube (PMT) and its impact on the MMB assay.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics (method comparison, precision, linearity, LoB, LoD, LoQ) for the modified system and implicitly assumes that these demonstrate substantial equivalence to the predicate device. For this response, I will interpret the performance data provided as the "reported device performance" and infer the implied "acceptance criteria" based on the comparison to the existing predicate and typical performance expectations for such devices.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (Modified System) |
|---|---|---|
| Method Comparison | Close agreement with predicate device (slope near 1, intercept near 0, high correlation). | Passing-Bablok Regression: Slope = 0.99 (95% CI: 0.98 - 0.99), Intercept = -0.16 ng/dL (95% CI: -0.20 - -0.10). Linear Regression: Slope = 0.97, Intercept = 0.64, Correlation Coefficient = 0.999. (Range: 1.0 - 274.0 ng/mL) |
| Precision (Repeatability) | Low coefficient of variation (CV) at various concentration levels. | QC1 (8.66 ng/mL): SD = 0.15, %CV = 1.72. QC2 (24.13 ng/mL): SD = 0.36, %CV = 1.50. QC3 (70.73 ng/mL): SD = 0.91, %CV = 1.28. Plasma Pool 1 (3.26 ng/mL): SD = 0.15, %CV = 4.71. Plasma Pool 2 (6.15 ng/mL): SD = 0.15, %CV = 2.45. |
| Precision (Within-Lab) | Low coefficient of variation (CV) at various concentration levels. | QC1 (8.66 ng/mL): SD = 0.22, %CV = 2.59. QC2 (24.13 ng/mL): SD = 0.56, %CV = 2.30. QC3 (70.73 ng/mL): SD = 1.27, %CV = 1.80. Plasma Pool 1 (3.26 ng/mL): SD = 0.19, %CV = 5.99. Plasma Pool 2 (6.15 ng/mL): SD = 0.21, %CV = 3.40. |
| Linearity | Demonstrated linearity across the assay range (slope near 1, intercept near 0, high correlation). | Range: 0 – 313.5 ng/mL. Slope = 1.004, Intercept = 0.170, Correlation Coefficient = 0.999. |
| Limit of Blank (LoB) | Acceptably low. | 0.4 ng/mL. |
| Limit of Detection (LoD) | Acceptably low (proportion of false positives/negatives |
§ 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.