(23 days)
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma.
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 kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The Elecsys® CK-MB test principle is based on a two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection. Total duration of the assay: 9 minutes 1ª incubation: 15 ul of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex 2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
- Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
This document is a 510(k) summary for a medical device and does not contain studies proving the device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing detailed studies against pre-defined acceptance criteria in the way a pharmaceutical trial or a software validation study might.
Therefore, most of the requested information regarding study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from the provided text.
However, I can provide the limited information that is present regarding the device and its intended use.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report performance against such criteria. It states that the device is "substantially equivalent" to a predicate device, meaning its performance is considered comparable, not necessarily meeting specific numerical thresholds outlined in this submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a laboratory immunoassay device, not an imaging or diagnostic device relying on expert interpretation for ground truth in the traditional sense. Ground truth for an immunoassay typically refers to accurate measurements by a reference method or known concentrations of analytes. However, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an automated immunoassay device, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone immunoassay system. The document describes its mechanism as an automated process: "Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code." This implies a standalone algorithm's performance in generating quantitative results. However, there's no mention of a separate "standalone study" with specific performance metrics (e.g., sensitivity, specificity, accuracy) detailed in this summary.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not explicitly stated. For an immunoassay, ground truth would typically be established by highly accurate reference methods or known concentrations of the analyte (CK-MB).
8. The sample size for the training set
Not provided. The document describes the assay principle and its components but does not detail internal validation or development datasets.
9. How the ground truth for the training set was established
Not provided.
Summary of available information:
- Device Name: Elecsys® CK-MB STAT Assay
- Intended Use: Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma. Used in the diagnosis and treatment of myocardial infarction and muscle diseases.
- Predicate Device: Boehringer Mannheim Elecsys CK-MB STAT (K961501) (first generation).
- Key Modification: Addition of an anti-BB antibody to Reagent 1.
- Claimed Equivalence: Substantially equivalent to the predicate device.
- Assay Principle: Two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.
- Assay Duration: 9 minutes (rapid STAT assay).
§ 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.