The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.
Device Story
ACS CKMB II is a two-site chemilumometric (sandwich) immunoassay; utilizes monoclonal mouse anti-CK-MB antibody labeled with acridinium ester and monoclonal mouse anti-CK-BB antibody coupled to paramagnetic particles. Input: serum or plasma samples. Operation: automated on Ciba Corning ACS:180 systems; detects relative light units (RLUs) proportional to CK-MB concentration. Output: quantitative CK-MB concentration (ng/mL). Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing myocardial infarction.
Clinical Evidence
Bench testing only. Accuracy evaluated using 1744 samples (0.0-280.0 ng/mL) comparing ACS CKMB II to FEIA reference method; correlation coefficient r=0.96; regression equation: y = 1.01x + 0.24. Sensitivity: minimum detectable concentration 0.18 ng/mL; range up to 300.0 ng/mL. Precision: total % CV 3.0-3.5%.
Technological Characteristics
Non-competitive chemiluminescence immunoassay. Reagents: monoclonal mouse anti-CK-MB (acridinium ester labeled) and monoclonal mouse anti-CK-BB (paramagnetic particle coupled). Automated system (ACS:180) detection of relative light units. Quantitative measurement range 0.18-300.0 ng/mL.
Indications for Use
Indicated for quantitative determination of CK-MB (CK-2) in human serum or plasma samples to aid in the diagnosis of myocardial infarction.
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
Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay (510(k) number not known)
Submission Summary (Full Text)
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Company Confidential
K96a126
# JUN 21 1996
# Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
## 1. Submitter Information
Contact person: Thomas F. Flynn
Address: Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052
Phone: 508 359-3877
FAX: 508 359-3885
e-mail: thomas.flynn@cibadiag.com
Date Summary Prepared: May 30, 1996
## 2. Device Information
Proprietary Name: ACS CKMB II Immunoassay
Common Name: CK-MB Immunoassay
Classification Name: Class II, Creatine phosphokinase/creatine kinase or Isoenzymes test system, 21 CFR 862.1215
## 3. Predicate Device Information
Name: Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay
Manufacturer: Baxter
510(k) Number: Not Known
## 4. Device Description
The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay, which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes.
## 5. Statement of Intended Use
The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.
ACS CKMB 510(k) Notification
May 30, 1996
2
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Company Confidential
## 6. Summary of Technological Characteristics
The Ciba Corning CKMB II assay is a non-competitive chemiluminescence assay.
## 7. Performance Data
### Sensitivity
The ACS CKMB II assay measures CK-MB concentrations up to 300.0 ng/mL with a minimum detectable concentration of 0.18 ng/mL.
### Accuracy
For 1744 samples in the range of 0.0 to 280.0 ng/mL, the correlation between the ACS CKMB II assay and the FEIA reference method assay is described by the equation:
$$
\text{ACS CKMB II} = 1.01 \times (\text{FEIA reference method}) + 0.24
$$
Correlation coefficient (r) = 0.96
### Precision
Total precision (Total % CV) ranged from 3.0 to 3.5.
ACS CKMB 510(k) Notification
May 30, 1996
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