ELECSYS CK-MB

K961501 · Boehringer Mannheim Corp. · JHW · Jun 11, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961501
• Device Name: ELECSYS CK-MB
• Applicant: Boehringer Mannheim Corp.
• Product Code: JHW · Clinical Chemistry
• Decision Date: Jun 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

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

Device Story

Elecsys CK-MB is an automated immunoassay system for quantitative measurement of CK-MB in human serum/plasma. Input: 15 μl sample. Principle: two-step sandwich immunoassay using biotinylated monoclonal CK-MB-specific antibody and ruthenium-labeled monoclonal CK-MB-specific antibody; streptavidin-coated microparticles capture complex on electrode surface. Output: chemiluminescent emission measured by photomultiplier, converted to concentration via calibration curve. Used in clinical laboratory settings; operated by laboratory technicians. Results assist physicians in diagnosing myocardial infarction and muscle diseases. Benefits include reduced sample volume (15 μl vs 150 μl) and improved sensitivity compared to predicate.

Clinical Evidence

Bench testing only. Precision studies (N=60 per sample) showed total CVs 4.1-5.1%. Sensitivity: lower detection limit 0.150 ng/ml. Method comparison vs. Abbott IMx (N=95) yielded r=0.996. Interference testing performed for hemoglobin, lipemia, and bilirubin. Specificity tested against CK-BB and CK-MM isoenzymes.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection. Uses streptavidin-coated microparticles and ruthenium-labeled antibodies. Requires Elecsys 2010 analyzer. Sample volume: 15 μl. Assay range: 0.100-500.0 ng/ml. Calibration via 2-point curve and reagent bar code.

Indications for Use

Indicated for in vitro quantitative determination of CK-MB isoenzyme in human serum and plasma to aid in diagnosis and treatment of myocardial infarction and muscle diseases (e.g., progressive, Duchenne-type muscular dystrophy).

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

• Abbott IMx CK-MB (K931172)

Reference Devices

• Hybritech Tandem®-E CK-MB

Submission Summary (Full Text)

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K961501
JUN 11 1996
510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| --- | --- |
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: LeeAnn Chambers

Date Prepared: April 12, 1996 |
| 2) Device name | Proprietary name: Elecsys® CK-MB

Common name: creatine kinase test |
| 3) Predicate device | We claim substantial equivalence to the Abbott IMx CK-MB (K931172) |
| 4) Device Description | 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
• 1st incubation: 15 μl of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex react to form a sandwich complex
• 2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. |

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510(k) Summary, Continued

4) Device Description, (cont.)
- 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.

5) Intended use
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

6) Comparison to predicate device
The Boehringer Mannheim Elecsys® CK-MB is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott IMx CK-MB.

The following table compares the Elecsys® CK-MB with the predicate device, Abbott IMx CK-MB. Specific data on the performance of the test have been incorporated into the draft labeling in section 5. Labeling for the predicate device is provided in section 6.

Similarities:
- Intended use: immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB)
- Sample type - human serum or plasma
- Two step sandwich immunoassay
- Mouse monoclonal antibody utilized to capture the CK-MB analyte

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510(k) Summary, Continued

6) Comparison to predicate device, (cont.)
Differences:

| Feature | Elecsys® CK-MB | IMx CK-MB |
| --- | --- | --- |
| Reaction test principle | streptavidin microparticles and electrochemiluminescence technology | antibody coated microparticles and enzyme immunoassay technology |
| Instrument required | Elecsys 2010 analyzer | Abbott IMx System |
| Sample volume | 15μl | 150 μl |

Performance Characteristics:

| Feature | Elecsys® CK-MB | | | | | IMx CK-MB | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| NCCLS (modif.) | | | | | | | | |
| Precision | HS1 | HS2 | HS3 | CCI | CCII | 1 | 2 | 3 |
| Sample | 60 | 60 | 60 | 60 | 60 | 48 | 48 | 48 |
| N | 5.40 | 26.8 | 107.7 | 4.72 | 65.5 | 5.0 | 20.1 | 116.5 |
| Mean | 3.0 | 3.5 | 3.7 | 3.9 | 3.5 | 4.5 | 4.2 | 3.0 |
| wi/in run %CV | 5.1 | 4.1 | 4.4 | 4.6 | 4.4 | 6.3 | 6.1 | 5.4 |
| total run %CV | | | | | | | | |
| Sensitivity | Lower Detection Limit: 0.150 ng CK-MB / ml | | | | | Lower Detection Limit: 0.7 ng CK-MB / ml | | |
| Assay Range (LDL to highest standard) | 0.100 - 500.0 ng/ml | | | | | 0.7 - 300 ng/ml | | |
| Method Comparison | vs. Abbott IMx CK-MB (Least Squares)
N = 95
y = 0.9735 + 1.0224x
r = 0.996
(Passing/Bablok)
N = 95
y = 0.2095 + 0.9465x
r = 0.996 | | | | | vs. Hybritech Tandem®-E CK-MB
N = 693
y = -0.52 + 0.82x
r = 0.975 | | |

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510(k) Summary, Continued

6) Comparison Performance Characteristics (cont.) to predicate device, (cont.)

| Interfering substances: Hemoglobin Lipemia Bilirubin | No interference at: 1.0 g/dl 1,500 mg/dl 28 mg/dl | No interference at: 50 mg/dl 750 mg/dl 1,000 mg/dl |
| --- | --- | --- |
| Specificity CK-BB | % Cross-reactivity 0.0600 (1,000 ng/ml) 0.1600 (2,500 ng/ml) 0.0020 (5,000 ng/ml) 0.0000 (10,000 ng/ml) | % Cross-reactivity 0.0005 (10,000 ng/ml) |
| CK-MM | 0.0500 (1,000 ng/ml) 0.0000 (2,500 ng/ml) 0.0000 (5,000 ng/ml) 0.0030 (10,000 ng/ml) | 0.012 (5,000 ng/ml) |