(21 days)
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No
The summary describes a standard in vitro diagnostic immunoassay and analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as an "in vitro diagnostic test" used for the diagnosis and treatment of conditions, not for directly providing therapy.
Yes
The intended use explicitly states "Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infarction and muscle diseases". The device description also calls it an "in vitro diagnostic test".
No
The device description clearly states it is an "in vitro diagnostic test" and is processed on specific hardware analyzers (Stratus®, Stratus® II, or Stratus® IIntellect). This indicates it is a hardware-dependent assay, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Device Description" explicitly states: "The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase."
The "Intended Use / Indications for Use" also describes how the measurements are used in the diagnosis and treatment of medical conditions, which is a key characteristic of IVD devices.
N/A
Intended Use / Indications for Use
Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Product codes (comma separated list FDA assigned to the subject device)
JHX
Device Description
The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.
The Stratus® CK-MB Fluorometric Enzyme Immunoassay has been cleared by the Food and Drug Administration, via its 510(k) process, for use with human serum samples. This submission supports expansion of the sample type to include human heparinized plasma samples. There have been no modifications in configuration or formulation to the Stratus® CK-MB Fluorometric Enzyme Immunoassay.
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)
A comparison study between serum and heparinized plasma samples was conducted with the following results:
Serum/Plasma (n = 160 rats) comparison showed a Slope of 1.17, Intercept of 1.6, Correlation Coefficient of 0.976, and Range of Samples from 0 - 113.1 ng/mL.
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.
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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.
0
K972782
Aug 15, 1997
DADE INTERNATIONAL
Chemistry Systems P.O. Box 6101 Newark, DE 19714
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Stratus® CK-MB Fluorometric Enzyme Immunoassay
Summary of Safety and Effectiveness
The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.
The Stratus® CK-MB Fluorometric Enzyme Immunoassay has been cleared by the Food and Drug Administration, via its 510(k) process, for use with human serum samples. This submission supports expansion of the sample type to include human heparinized plasma samples. There have been no modifications in configuration or formulation to the Stratus® CK-MB Fluorometric Enzyme Immunoassay.
A comparison study between serum and heparinized plasma samples was conducted with the following results:
| | Slope | Intercept | Correlation
Coefficient | Range of
Samples |
|--------------------------------|-------|-----------|----------------------------|---------------------|
| Serum/Plasma
(n = 160 rats) | 1.17 | 1.6 | 0.976 | 0 - 113.1 ng/mL |
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
July 23, 1997
Date
Image /page/0/Picture/15 description: The image shows a logo indicating that the item was printed on recycled paper with 25% post-consumer fiber. The logo features a recycling symbol with three arrows forming a circle. Below the logo, there is some illegible text.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
AUG 1 5 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carolyn K. George Requlatory Affairs and Compliance Manager -Dade International Post Office Box 6101 Newark, DE 19714
K972782 Re: Stratus® CK-MB Fluorometric Enzyme Immunoassay Regulatory Class: II Product Code: JHX Dated: July 24, 1997 Received: July 25, 1997
Dear Ms. George:
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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 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 marress 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/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
3
Indications Statement
Device Name: Stratus® CK-MB Fluorometric Enzyme Immunoassay
Indications for Use: Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Audrey K. George
arolyn K. George Regulatory Affairs and Compliance Manager
July 23 1997
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
(Per 21 CFR 801. 109)
510(k) Number
Ablagman Lee R. Montgomery
Division Sign Off
Office of Device Evaluation
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