(69 days)
Not Found
No
The device description details a chemical reaction and enzymatic assay for measuring CK-MB, with no mention of AI or ML technologies. The performance studies focus on traditional analytical metrics like precision, assay range, sensitivity, and method comparison.
No
This device is a system reagent used for the quantitative determination of an isoenzyme, CK-MB, which aids in diagnosis. It does not provide any treatment or therapy.
Yes
The first sentence of the "Intended Use / Indications for Use" section states, "Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy." This explicitly indicates a diagnostic purpose.
No
The device description clearly outlines a chemical reagent and its interaction with biological samples on specific hardware analyzers (Olympus analyzers). This is a laboratory diagnostic test involving physical components (reagents) and hardware (analyzers), not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the "Intended Use / Indications for Use" is for the "quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma". This is a classic definition of an in vitro diagnostic test, as it involves analyzing biological samples outside of the body to provide information for diagnosis and treatment.
- Device Description: The description details a biochemical reaction that occurs with the sample and reagents to measure the CK-MB activity. This process is performed in vitro (in a test tube or analyzer).
- Performance Studies: The document describes performance studies like precision, assay range, sensitivity, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K971817) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.
All of these elements strongly indicate that this device is designed and intended for use as an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 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."
Product codes (comma separated list FDA assigned to the subject device)
JHY
Device Description
"In this Olympus procedure: 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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics tables comparing Olympus CK-MB (OSR6x155) reagent with the predicate system.
Precision:
AU400/400°:
Sample 1: Total CV% 4.26 (new) vs 2.85 (predicate)
Sample 2: Total CV% 1.31 (new) vs 0.65 (predicate)
Sample 3: Total CV% 1.10 (new) vs 0.52 (predicate)
AU600/640/640°:
Sample 1: Total CV% 5.05 (new) vs 9.12 (predicate)
AU2700/5400:
Sample 1: Total CV% 3.50 (new) vs 5.59 (predicate)
Sample 2: Total CV% 1.13 (new) vs 3.54 (predicate)
Sample 3: Total CV% 1.21 (new) vs 3.76 (predicate)
Assay Range: 10 to 2000 U/L for both new and predicate.
Sensitivity:
New: Typical change in absorbance per minute for 1 U/L of CK-MB is approximately 0.12 mAbsorbance
Predicate: Typical change in absorbance per minute for 1 U/L of CK-MB is approximately 0.08 mAbsorbance
Method Comparison (Linear Regression):
Intercept: 2.207 (new) vs 2.700 (predicate)
Slope: 1.061 (new) vs 0.965 (predicate)
R2: 1.000 (new) vs 1.000 (predicate)
Range: 12-1860 U/L (new) vs 2-1881 U/L (predicate)
Interfering Substances:
AU600/640/640e:
Bilirubin: Interference less than 10% up to 40 mg/dL Bilirubin (new) vs less than 3% up to 40 mg/dL Bilirubin (predicate)
Lipemia: Interference less than 15% up to 900 mg/dL Intralipid (new) vs less than 10% up to 200 mg/dL Intralipid (predicate)
AU400/400e:
Bilirubin: Interference less than 10% up to 40 mg/dL Bilirubin (new) vs less than 3% up to 40 mg/dL Bilirubin (predicate)
Lipemia: Interference less than 10% up to 900 mg/dL Intralipid (new) vs less than 3% up to 1000 mg/dL Intralipid (predicate)
AU2700/5400:
Bilirubin: Interference less than 6% up to 40 mg/dL Bilirubin (new) vs less than 10% up to 24 mg/dL Bilirubin (predicate)
Lipemia: Interference less than 20% up to 900 mg/dL Intralipid (new) vs less than 6% up to 1000 mg/dL Intralipid (predicate)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
"Typical change in absorbance per minute for 1 U/L of CK-MB is approximately 0.12 mAbsorbance" (new device)
"Typical change in absorbance per minute for 1 U/L of CK-MB is approximately 0.08 mAbsorbance" (predicate device)
Precision (Total CV%): detailed in "Summary of Performance Studies"
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
510(k) Summary
in summary of the 510(k) safety and effectiveness information is being submitted in acc
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
Material Science
Europa GmbH
Lismeehan,
O'Callaghan's Mills
Co. Clare, Ireland | JUN - 4 |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| | | U.S. Telephone:
U.S. Fax:
Telephone: | 469-230-0959
972-317-7861
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
test system. |
| 3. | Predicate device | Reagent: | Olympus OSR6X53 CK-MB method
Submitted (K971817) |
| 4. | Device description | In this Olympus procedure:
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
Kinase-MB isoenzyme in human serum and plasma on Olympus
analyzers. | |
2007
1
510(k) Summary
The assigned 510(k) number is: 5070835
- ნ.
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 | |
| modification of the IFCC method | This Olympus CK procedure is a | |
| modification of the Szasz method | ||
| Reagent storage form | Liquid | |
| On -board storage | Reconstituted | |
| On -board storage | ||
| Reagent Handling | R1: Mix R1-2 into R1-1 before placing | |
| on instrument. | ||
| R2 Ready for use | R1: Dissolve the contents of one R1 Lyo | |
| completely with the contents of one bottle | ||
| of R1 Buffer. | ||
| R2: Dissolve the contents of one R2 Lyo | ||
| completely with the contents of one bottle | ||
| of R2 Buffer | ||
| Reagent On Board Stability | Opened reagents are stable for 30 | |
| days when stored in the refrigerated | ||
| compartment of the analyzer. | Reconstituted reagents are stable for 5 | |
| days when stored in the refrigerated | ||
| 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 | |
| based upon the theoretical extinction | ||
| coefficient for NADPH, which has a molar | ||
| absorptivity of 6300 at | ||
| 340/660 nm | Calibration of this CK-MB procedure is | |
| based upon the theoretical extinction | ||
| coefficient for NADP, which has a molar | ||
| absorptivity of 4960 at | ||
| 340/380 nm |
| Performance Characteristics | ||||
|---|---|---|---|---|
| Item | Olympus CK-MB (OSR6x155) reagent | Predicate System | ||
| Precision | AU400/400° | |||
| Sample | ||||
| 1 | ||||
| 2 | ||||
| 3 | AU400/400° | |||
| Sample | ||||
| 1 | ||||
| 2 | ||||
| 3 | ||||
| Total CV% | ||||
| 4.26 | ||||
| 1.31 | ||||
| 1.10 | Total CV% | |||
| 2.85 | ||||
| 0.65 | ||||
| 0.52 | ||||
| AU600/640/640° | ||||
| Sample | ||||
| 1 | AU600/640/640° | |||
| Sample | ||||
| 1 | ||||
| Total CV% | ||||
| 5.05 | Total CV% | |||
| 9.12 |
2
510(k) Summary
The assigned 510(k) Summan ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| 2 | 1.15 | 2 | 1.62 | ||
|---|---|---|---|---|---|
| 3 | 0.90 | 3 | 0.73 | ||
| AU2700/5400 | |||||
| Sample | |||||
| Total CV% | AU2700/5400 | ||||
| Sample | |||||
| 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 | ||||
| minute for 1 U/L of CK-MB is | |||||
| approximately 0.12 mAbsorbance | Typical change in absorbance per | ||||
| minute for 1 U/L of CK-MB is | |||||
| approximately 0.08 mAbsorbance | |||||
| Method Comparison (Linear | |||||
| 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 | ||||
| Bilirubin: Interference less than 10% | |||||
| up to 40 mg/dL Bilirubin | |||||
| Lipemia: Interference less than 15% up | |||||
| to 900 mg/dL Intralipid | AU600/640/640e | ||||
| Bilirubin: Interference less than 3% up | |||||
| to 40 mg/dL Bilirubin | |||||
| Lipemia: Interference less than 10% up | |||||
| to 200 mg/dL Intralipid | |||||
| AU400/400e | |||||
| Bilirubin: Interference less than 10% | |||||
| up to 40 mg/dL Bilirubin | |||||
| Lipemia: Interference less than 10% up | |||||
| to 900 mg/dL Intralipid | AU400/400e | ||||
| Bilirubin: Interference less than 3% up | |||||
| to 40 mg/dL Bilirubin | |||||
| Lipemia: Interference less than 3% up | |||||
| to 1000 mg/dL Intralipid | |||||
| AU2700/5400 | |||||
| Bilirubin: Interference less than 6% up | |||||
| to 40 mg/dL Bilirubin | |||||
| Lipemia: Interference less than 20% up | |||||
| to 900 mg/dL Intralipid | AU2700/5400 | ||||
| Bilirubin: Interference less than 10% | |||||
| up to 24 mg/dL Bilirubin | |||||
| Lipemia: Interference less than 6% up | |||||
| to 1000 mg/dL Intralipid |
3
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).
4
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
5
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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