(23 days)
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No
The description details a standard immunoassay based on electrochemiluminescence detection and calibration curves, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) immunoassay designed to measure levels of CK-MB for diagnostic purposes, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that measurements of creatine kinase and its isoenzymes are used in the "diagnosis and treatment of myocardial infarction and muscle diseases". This indicates the device provides information crucial for diagnosis.
No
The device description clearly outlines a laboratory immunoassay system involving physical reagents, microparticles, magnetic capture, and electrochemiluminescence detection, which are all hardware components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Purpose: The description of the test system clearly states its use "in the diagnosis and treatment of myocardial infarction and muscle diseases". This indicates a medical purpose for the test results, which is characteristic of an IVD.
- Sample Type: The test is performed on "human serum and plasma," which are biological samples taken from the body but tested outside of it. This is another defining feature of an IVD.
- Device Description: The description details a laboratory-based assay using reagents and an instrument to measure a substance in a biological sample. This aligns with the nature of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K961501) indicates that this device has gone through a regulatory process, likely with the FDA, as a medical device, specifically an IVD.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JHY
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 1ª incubation: 15 ul of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex 2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. 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 instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
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Boehringer Mannheim Corporation Elecsys® CK-MB STAT 510(k) November, 1997
510(k) Summary
DEC 17 1997
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
Boehringer Mannheim Corporation 1. Submitter 4300 Hacienda Drive name, address, Pleasanton, CA 94588-2722 contact (510) 730 - 8415 Contact Person: Jody J. Savage
Date Prepared: November 21, 1997
- Device name Proprietary name: Elecsys CK-MB STAT Assay
Common name: Creatine Kinase Test
Classification name: Colorimetric method, CPK or Isoenzymes
- Predicate device
The Boehringer Mannheim Elecsys CK-MB STAT is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed first generation Boehringer Mannheim Elecsys CK-MB STAT (K961501).
Continued on next page
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510(k) Summary, Continued
The Elecsys® CK-MB test principle is based on a two-step sandwich with 4. Streptavidin microparticles and electrochemiluminescence detection. Device Description Total duration of the assay: 9 minutes 1ª incubation: 15 ul of sample, a biotinylated monoclonal CK-MB-specific . antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex 2nd incubation: after the addition of streptavidin-coated microparticles, the . complex becomes bound to the solid phase via interaction of biotin and streptavidin. 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.
Continued on next page
2
510(k) Summary, Continued
Immunoassay for the in vitro quantitative determination of the MB isoenzyme 5. of creatine kinase (CK-MB) in human serum and plasma. Intended use 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. The Boehringer Mannheim Elecsys CK-MB STAT as described in this 6. Comparison to submission is substantially equivalent to other products in commercial predicate device distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed first generation Boehringer Mannheim Elecsys CK-MB STAT assay (K961501). The first generation Boehringer Mannheim Elecsys CK-MB assay (K961501) was cleared for use on June 11, 1996, and is in commercial distribution. Subsequent to clearance, the Elecsys CK-MB was renamed the Elecsys CK-MB STAT, to emphasize the rapid (9 minute) assay time. This current submission reflects the addition of an anti-BB antibody to Reagent 1 of the
Elecsys CK-MB STAT assay. This modification does not affect the intended use of the device or the basic fundamental scientific technology of the device.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a series of flowing lines that form the shape of a bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 1997
Jody J. Savage Consultant, Regulatory Affairs Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 94588-2722 Pleasanton, California
K974421 Re: Elecsys® CK-MB STAT Assay Requlatory Class: II Product Code: JHY November 21, 1997 Dated: November 24, 1997 Received:
Dear Ms. Savage:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice is substantially equivalent (for the indications for use stated in the enclosure) to 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 The general controls provisions of the Act 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations .
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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 one rogalation Chorona, (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/dsmamain.html".
Sincerely yours,
Steven Litman
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
5
510(k) Number (if known): N/A
Device Name: Elecsys CK-MB STAT Assay
Indications For 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.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | ||
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices,
| 510(k) Number | |
|---|---|
| --------------- | -- |
U:\QA_QC\QA\RA\Elecsys\510(k)'s\CK-MB\CK-MB 510k FDA.doc