OLYMPUS CK-MB REAGENT
Device Facts
| Record ID | K070835 |
|---|---|
| Device Name | OLYMPUS CK-MB REAGENT |
| Applicant | Olympus Life & Material Science Europa GmbH (Irish |
| Product Code | JHY · Clinical Chemistry |
| Decision Date | Jun 4, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1215 |
| Device Class | Class 2 |
Intended Use
System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and heparinized plasma on OLYMPUS analyzers Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Device Story
The Olympus CK-MB Reagent is an in vitro diagnostic reagent used on Olympus AU-series analyzers. It utilizes an immunoinhibition method where a polyclonal anti-CK-M goat antibody binds to the M subunit of CK in the patient sample. The remaining B subunit activity is measured via a coupled enzymatic reaction: CK catalyzes the transfer of a phosphate group from creatine phosphate to ADP, producing ATP; hexokinase converts ATP and glucose to glucose-6-phosphate; G6P-DH oxidizes glucose-6-phosphate while reducing NADP to NADPH. The rate of increase in absorbance at 340/660 nm, proportional to NADPH formation, is measured by the analyzer. Results are used by clinicians to diagnose and monitor myocardial infarction and muscular dystrophies. The device is intended for professional use in clinical laboratory settings.
Clinical Evidence
Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80, CVs < 6.5%). Linearity confirmed 10-2000 U/L per CLSI EP6-P2. Method comparison (n=103) against predicate showed correlation coefficient of 1.000 (y = 1.061x + 2.207). Matrix comparison (serum vs heparin plasma) showed correlation of 1.000. Interference testing performed per CLSI EP7-A.
Technological Characteristics
Liquid reagent system for automated clinical chemistry analyzers. Principle: Immunoinhibition of CK-M subunit followed by kinetic colorimetric measurement of CK-B activity. Detection: Absorbance at 340/660 nm. Calibration: Theoretical extinction coefficient for NADPH (molar absorptivity 6300). Antibody: Polyclonal anti-CK-M goat antibody. Compatible with Olympus AU400, AU600/640, and AU2700/5400 analyzers.
Indications for Use
Indicated for the quantitative determination of CK-MB isoenzyme in human serum and heparinized plasma to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as 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
- Olympus OSR6X53 CK-MB method (K971817)
Related Devices
- K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 · Olympus America, Inc. · Dec 23, 2004
- K994189 — OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 · Olympus Diagnostica GmbH · Jan 20, 2000
- K162526 — Creatine Kinase-MB · Roche Diagnostics · May 26, 2017
- K971817 — OLYMPUS CK-MB REAGENT · Olympus America, Inc. · Jun 11, 1997
Submission Summary (Full Text)
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#### 510(k) Summary
510(k) Summary
in summary of the 510(k) safety and effectiveness information is being submitted in acc
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This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 1. | Submitter name, address, contact | Olympus Life and<br>Material Science<br>Europa GmbH<br>Lismeehan,<br>O'Callaghan's Mills<br>Co. Clare, Ireland | JUN - 4 |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| | | U.S. Telephone:<br>U.S. Fax:<br>Telephone: | 469-230-0959<br>972-317-7861<br>011-353-65-683-1100 |
| | | Contact Person: | Stephanie G. Schwartz |
| | | Date Prepared: | March 25, 2007 |
| 2. | Device name | Proprietary Name: | Olympus CK-MB Reagent (OSR6x155) |
| | | Common Name: | CK-MB Reagent |
| | | Classification Name: | Colorimetric Method, CPK or Isoenzymes<br>test system. |
| 3. | Predicate device | Reagent: | Olympus OSR6X53 CK-MB method<br>Submitted (K971817) |
| 4. | Device description | In this Olympus procedure:<br>The R1 reagent antibody binds to the M subunit of CK in the serum sample. The B subunit of the enzyme acts on the substrate present in the R2 reagent. CK reversibly catalyzes the transfer of a phosphate group from creatine phosphate to ADP to give creatine and ATP. The ATP is used to produce glucose-6-phosphate and ADP, catalyzed by hexokinase (HK) which requires magnesium ions for maximum activity. The glucose-6-phosphate is oxidized by the action of the enzyme G6P-DH with simultaneous reduction of the coenzyme NADP to give NADPH and 6-phosphogluconate. The rate of increase of absorbance at 340/660 nm due to the formation of NADPH is directly proportional to the activity of CK-MB in the sample. | |
| 5. | Intended use | System reagent for the quantitative determination of Creatine<br>Kinase-MB isoenzyme in human serum and plasma on Olympus<br>analyzers. | |
2007
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## 510(k) Summary
# The assigned 510(k) number is: 5070835
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The following Tables compare the new Olympus CK-MB (OSR6x155) reagent with the current Olympus CK-MB (OSR6x53) reagent.
| Similarities | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Olympus CK-MB (OSR6x155) reagent | Predicate System |
| Intended Use | System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma on Olympus analyzers. | System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma on Olympus analyzers. |
| Instrument required | Olympus AU400/400°, 600/640/640° and 2700/5400 | Same |
| Measurement | Quantitative | Same |
| Specimen Type | Serum and heparinized plasma | Same |
| Assay Methodology | Isoenzymes | Same |
| Antibody | Antibody to CK-M subunit | Same |
| Calibration | Procedure is based upon a theoretical extinction coefficient. | Same |
| Expected Values | 1 - 10 U/L | Same |
| Differences | | |
| Item | Olympus CK-MB (OSR6x155) reagent | Predicate System |
| Traceability | This Olympus CK procedure is a<br>modification of the IFCC method | This Olympus CK procedure is a<br>modification of the Szasz method |
| Reagent storage form | Liquid<br>On -board storage | Reconstituted<br>On -board storage |
| Reagent Handling | R1: Mix R1-2 into R1-1 before placing<br>on instrument.<br>R2 Ready for use | R1: Dissolve the contents of one R1 Lyo<br>completely with the contents of one bottle<br>of R1 Buffer.<br>R2: Dissolve the contents of one R2 Lyo<br>completely with the contents of one bottle<br>of R2 Buffer |
| Reagent On Board Stability | Opened reagents are stable for 30<br>days when stored in the refrigerated<br>compartment of the analyzer. | Reconstituted reagents are stable for 5<br>days when stored in the refrigerated<br>compartment of the analyzer. |
| Antibody | Polyclonal anti CK-M goat antibody | Polyclonal anti CK-M sheep antibody |
| Calibration | Calibration of this CK-MB procedure is<br>based upon the theoretical extinction<br>coefficient for NADPH, which has a molar<br>absorptivity of 6300 at<br>340/660 nm | Calibration of this CK-MB procedure is<br>based upon the theoretical extinction<br>coefficient for NADP, which has a molar<br>absorptivity of 4960 at<br>340/380 nm |
| | | Performance Characteristics | | |
|-----------|--|-------------------------------------|-------------------------------------|--|
| Item | | Olympus CK-MB (OSR6x155) reagent | Predicate System | |
| Precision | | AU400/400°<br>Sample<br>1<br>2<br>3 | AU400/400°<br>Sample<br>1<br>2<br>3 | |
| | | Total CV%<br>4.26<br>1.31<br>1.10 | Total CV%<br>2.85<br>0.65<br>0.52 | |
| | | AU600/640/640°<br>Sample<br>1 | AU600/640/640°<br>Sample<br>1 | |
| | | Total CV%<br>5.05 | Total CV%<br>9.12 | |
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## 510(k) Summary
The assigned 510(k) Summan ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| | 2 | 1.15 | | 2 | 1.62 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | 3 | 0.90 | | 3 | 0.73 |
| | AU2700/5400<br>Sample<br>Total CV% | | | AU2700/5400<br>Sample<br>Total CV% | |
| | 1 | 3.50 | | 1 | 5.59 |
| | 2 | 1.13 | | 2 | 3.54 |
| | 3 | 1.21 | | 3 | 3.76 |
| Assay Range | 10 to 2000 U/L | | | 10 to 2000 U/L | |
| Sensitivity | Typical change in absorbance per<br>minute for 1 U/L of CK-MB is<br>approximately 0.12 mAbsorbance | | | Typical change in absorbance per<br>minute for 1 U/L of CK-MB is<br>approximately 0.08 mAbsorbance | |
| Method Comparison (Linear<br>Regression) | Intercept | 2.207 | | Intercept | 2.700 |
| | Slope | 1.061 | | Slope | 0.965 |
| | R2 | 1.000 | | R2 | 1.000 |
| | Range | 12-1860 U/L | | Range | 2-1881 U/L |
| Interfering Substances | AU600/640/640e<br>Bilirubin: Interference less than 10%<br>up to 40 mg/dL Bilirubin<br>Lipemia: Interference less than 15% up<br>to 900 mg/dL Intralipid | | | AU600/640/640e<br>Bilirubin: Interference less than 3% up<br>to 40 mg/dL Bilirubin<br>Lipemia: Interference less than 10% up<br>to 200 mg/dL Intralipid | |
| | AU400/400e<br>Bilirubin: Interference less than 10%<br>up to 40 mg/dL Bilirubin<br>Lipemia: Interference less than 10% up<br>to 900 mg/dL Intralipid | | | AU400/400e<br>Bilirubin: Interference less than 3% up<br>to 40 mg/dL Bilirubin<br>Lipemia: Interference less than 3% up<br>to 1000 mg/dL Intralipid | |
| | AU2700/5400<br>Bilirubin: Interference less than 6% up<br>to 40 mg/dL Bilirubin<br>Lipemia: Interference less than 20% up<br>to 900 mg/dL Intralipid | | | AU2700/5400<br>Bilirubin: Interference less than 10%<br>up to 24 mg/dL Bilirubin<br>Lipemia: Interference less than 6% up<br>to 1000 mg/dL Intralipid | |
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Olympus Life & Material Science Europa GMBH (Irish Branch) c/o Ms. Stephanie Schwartz Regulatory Affairs/Quality Assurance Manager Lismeehan, O'Callaghan's Mills, CO. Clare, Ireland
JUN - 4 2007
Re: k070835 Trade/Device Name: Olympus CK-MB Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHY Dated: March 24, 2007 Received: March 27, 2007
Dear Ms. Schwartz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
· Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): k070835
Device Name:
Olympus CK-MB Reagent
Indications For Use:
System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and heparinized plasma on OLYMPUS analyzers
Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
708
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