(23 days)
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.
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 instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
This document is a 510(k) summary for a medical device and does not contain studies proving the device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing detailed studies against pre-defined acceptance criteria in the way a pharmaceutical trial or a software validation study might.
Therefore, most of the requested information regarding study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from the provided text.
However, I can provide the limited information that is present regarding the device and its intended use.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report performance against such criteria. It states that the device is "substantially equivalent" to a predicate device, meaning its performance is considered comparable, not necessarily meeting specific numerical thresholds outlined in this submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a laboratory immunoassay device, not an imaging or diagnostic device relying on expert interpretation for ground truth in the traditional sense. Ground truth for an immunoassay typically refers to accurate measurements by a reference method or known concentrations of analytes. However, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an automated immunoassay device, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone immunoassay system. The document describes its mechanism as an automated process: "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." This implies a standalone algorithm's performance in generating quantitative results. However, there's no mention of a separate "standalone study" with specific performance metrics (e.g., sensitivity, specificity, accuracy) detailed in this summary.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not explicitly stated. For an immunoassay, ground truth would typically be established by highly accurate reference methods or known concentrations of the analyte (CK-MB).
8. The sample size for the training set
Not provided. The document describes the assay principle and its components but does not detail internal validation or development datasets.
9. How the ground truth for the training set was established
Not provided.
Summary of available information:
- Device Name: Elecsys® CK-MB STAT Assay
- Intended Use: Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma. Used in the diagnosis and treatment of myocardial infarction and muscle diseases.
- Predicate Device: Boehringer Mannheim Elecsys CK-MB STAT (K961501) (first generation).
- Key Modification: Addition of an anti-BB antibody to Reagent 1.
- Claimed Equivalence: Substantially equivalent to the predicate device.
- Assay Principle: Two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.
- Assay Duration: 9 minutes (rapid STAT assay).
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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
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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
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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
§ 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.