(22 days)
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No
The summary describes a standard immunoassay for measuring CK-MB levels and does not mention any AI or ML components. The performance studies focus on analytical metrics like precision, recovery, and correlation, typical of laboratory assays, not AI/ML model performance.
No
This device is an in vitro diagnostic (IVD) immunoassay designed to measure CK-MB levels, which is used in the diagnosis of myocardial infarction, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction." This indicates the device provides information for diagnostic purposes.
No
The device description clearly states it includes reagent packs, calibrators, controls, substrate, and wash buffer, which are physical components, not software. It is designed for use with an "Access Immunoassay Analyzer," which is also a hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of CK-MB levels in human serum or plasma". This indicates the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" used with "human serum or plasma". This further confirms the in vitro nature of the testing.
- Clinical Laboratory Setting: The intended user/care setting is a "clinical laboratory setting", which is a typical environment for performing in vitro diagnostic tests.
- Purpose of Measurement: The intended use also states that "Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction." This clearly links the test results to a diagnostic purpose.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of transfusions, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Access CK-MB assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.
Product codes
JHX
Device Description
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems.
The Access CK-MB reagents consist of reagent packs, calibrators, controls substrate and wash buffer. The Access CK-MB assay, CK-MB calibrators, CK-MB QC along with the Access System Wash Buffer and Substrate are designed for use with the Access Immunoassay Analyzer in a clinical laboratory setting.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Precision:
Within-run, between-run, and total imprecision were less than 10% CV.
Spiking and Dilution Recovery:
Linearity studies performed by diluting one human sample containing CK-MB with CK-MB Calibrator S0 yields an average recovery of 95.7%.
Correlation:
A comparison of the Access CK-MB assay and the predicate device gives the following statistical data-n=356, r=0.984, y=0.836x + 0.662.
A comparison of CK-MB values of paired serum and plasma( EDTA) run in the Access CK-MB assay gives the following statistical data-n=48, r=0.998, y=1.009x + 1.119. A comparison of CK-MB values of palred serum and plasma (heparin) run in the Access CK-MB assay gives the following statistical data-n=84, r=0.999, y=1.015x - 0.631.
Analytical Sensitivity:
The lowest detectable level of CK-MB distinguishable for zero (CK-MB S0 calibrator) with 95% confidence is 0.3 ng/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Within-run, between-run, and total imprecision were less than 10% CV.
average recovery of 95.7%.
r=0.984
y=0.836x + 0.662
r=0.998
y=1.009x + 1.119
r=0.999
y=1.015x - 0.631
lowest detectable level of CK-MB is 0.3 ng/ml with 95% confidence.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 1 4 2000
5101k) Summarv January 11, 2000
Applicant's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Contact Person: Michele S. Gust
Device Name
Trade Name - Access® CK-MB Reagents on the Access® Immunoassay System Common Name - Access® CK-MB Classification name - Fluorometric Method, CPK or Isoenzymes
Device Description
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems.
The Access CK-MB reagents consist of reagent packs, calibrators, controls substrate and wash buffer. The Access CK-MB assay, CK-MB calibrators, CK-MB QC along with the Access System Wash Buffer and Substrate are designed for use with the Access Immunoassay Analyzer in a clinical laboratory setting.
Intended Use
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems.
Comparison of Technological Characteristics
The Access CK-MB assay and the predicate device are contain a solid phase of particles and use a labeted antibody conjugated to alkaline phosphatase. The calibrators consist of 6 levels in which the analyte is human CK-MB. Both of these devices are intended to measure CK-MB in human serum and plasma.
Summary of Studies
Precision:
Within-run, between-run, and total imprecision were less than 10% CV. Spiking and Dilution Recovery:
Linearity studies performed by diluting one human sample containing CK-MB with CK-MB Calibrator S0 yields an average recovery of 95.7%.
Correlation:
A comparison of the Access CK-MB assay and the predicate device gives the following statistical data-n=356, r=0.984, y=0.836x + 0.662.
A comparison of CK-MB values of paired serum and plasma( EDTA) run in the Access CK-MB assay gives the following statistical data-n=48, r=0.998, y=1.009x + 1.119. A comparison of CK-MB values of palred serum and plasma (heparin) run in the Access CK-MB assay gives the following statistical data-n=84, r=0.999, y=1.015x - 0.631. Analytical Sensitivity:
The lowest detectable level of CK-MB distinguishable for zero (CK-MB S0 calibrator) with 95% confidence is 0.3 ng/ml.
Conclusion
The Access CK-MB reagents when used with the Access Immunoassay Analyzer are substantially equivalent to another test currently in commercial distribution for the measurement of CK-MB.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2000
Ms. Michele S. Gust Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
Re: K994439
Trade Name: Access® CK-MB Assay on the Access® Immunoassay Analyzer Regulatory Class: II Product Code: JHX Dated: December 22, 1999 Received: December 23, 1999
Dear Ms. Gust:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Beckman Coulter, Inc.
510(k) Premarket Notification Confidential
Page of 1
510(k) Number (if known):
Device Name: Access® CK-MB-Reagent&Assay on the Access Immunoassay Analyzer
Indications For Use:
The AccEss® CK-MB assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Han Cooper
(Division Sign-Off)
Division of Clinical Labor
510(k) Number: 499439
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use_