ELECSYS CK-MB STAT IMMUNOASSAY

K140404 · Roche Diagnostics · JHY · May 8, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140404
• Device Name: ELECSYS CK-MB STAT IMMUNOASSAY
• Applicant: Roche Diagnostics
• Product Code: JHY · Clinical Chemistry
• Decision Date: May 8, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys CK-MB STAT Immunoassay is a sandwich immunoassay used for the quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. It utilizes streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. The device is intended for use on Roche cobas e immunoassay analyzers by laboratory professionals. The assay process involves a one-step incubation where the sample, biotinylated monoclonal anti-CK-MB antibody, ruthenium-labeled monoclonal CK-MB-specific antibody, and streptavidin-coated microparticles are added simultaneously to form a sandwich complex. This complex binds to the solid phase. The analyzer measures the electrochemiluminescent signal, and results are calculated using a calibration curve generated by a 2-point calibration and a master curve provided via reagent barcode. The output provides clinicians with quantitative CK-MB levels, which serve as an aid in the diagnosis of myocardial infarction, enabling timely clinical decision-making for cardiac patients.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that the one-step incubation modification meets acceptance criteria. Risk analysis conducted using ALARP methodology.

Technological Characteristics

Sandwich immunoassay using biotinylated and ruthenium-labeled antibodies with streptavidin-coated microparticles. Detection via electrochemiluminescence. Operates on cobas e 601 immunoassay analyzers. Reagent stability: 8 weeks on-analyzer. Calibration: 2-point calibration with master curve via barcode. Standards: CLSI EP5-A2, EP17-A, EP6-A.

Indications for Use

Indicated for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma to aid in the diagnosis of myocardial infarction. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• Elecsys CK-MB STAT Immunoassay (K132571)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k140404

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k), k132571, Elecsys CK-MB STAT Immunoassay. The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The assay protocol has been modified from a two-step incubation to a one-step incubation where the sample, reagent1, reagent 2 and the microparticles are added at one time.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis: ALARP
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.