(202 days)
For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately.
The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.
This document describes the SEKURE Creatine Kinase Assay, an in vitro diagnostic device, and its performance study to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The device performance is evaluated against various analytical metrics. While explicit "acceptance criteria" for each study are not individually listed as pass/fail thresholds in a table, the document reports the results of these studies, implying that the observed performance met internal or regulatory expectations for demonstrating substantial equivalence. The predicate device's characteristics serve as an implicit benchmark for similarity.
Here's a table summarizing the reported device performance, with implied acceptance based on the submission being cleared:
| Feature/Study | Acceptance Criteria (Implied) | Reported Device Performance (SEKURE Creatine Kinase Assay) | Predicate Device Performance (Creatine Kinase-SL Assay) |
|---|---|---|---|
| Intended Use | Quantitative measurement of CK activity in serum. | Quantitative measurement of CK activity in serum and plasma on SK500. | Quantitative measurement of CK activity in serum. |
| Methodology | Must be similar to predicate. | Colorimetric (NADPH), Enzymatic (coupled hexokinase-G6PD) | Colorimetric (NADPH), Enzymatic (coupled hexokinase-G6PD) |
| Specimen Type | Suitable for reported specimen types. | Serum and lithium heparin plasma. | Serum |
| Measuring Interval | Within a clinically relevant and acceptable range, similar to predicate. | 11-1500 U/L | 2-1500 U/L |
| Precision | Acceptable repeatability and within-laboratory variability (%CV, SD). CLSI EP05-A3 guidelines. | See Section "Precision" table (e.g., Repeatability %CV ranging from 0.6-1.3%, Within Laboratory %CV ranging from 1.2-3.6%). | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Blank (LoB) | Must be low and clinically acceptable. CLSI EP17-A2 guidance. | 3 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Detection (LoD) | Must be low and clinically acceptable. CLSI EP17-A2 guidance. | 5 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Limit of Quantitation (LoQ) | Clinically acceptable level. CLSI EP17-A2 guidance. | 11 U/L | Not explicitly detailed but assumed to meet similar standards. |
| Linearity/Reportable Range | Observed mean values within ±10% or ±3 U/L of theoretical values. CLSI EP06-A guidance. | Supported measuring range up to 1500 U/L for serum and plasma. | 2-1500 U/L |
| Analytical Specificity (Interference) | Significant interference |
§ 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.