(21 days)
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.
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.
Here's a breakdown of the acceptance criteria and study details for the Stratus® CK-MB Fluorometric Enzyme Immunoassay, based on the provided document:
Acceptance Criteria and Device Performance Study
The primary purpose of this submission (K972782) was to expand the sample type for the already cleared Stratus® CK-MB Fluorometric Enzyme Immunoassay from human serum to human heparinized plasma samples. The acceptance criteria for this expansion focused on demonstrating substantial equivalence between the performance of the assay when using serum compared to heparinized plasma.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state pre-defined acceptance criteria in terms of specific ranges for slope, intercept, or correlation coefficient. Instead, it presents the results of a comparison study between serum and heparinized plasma, implying that acceptable performance is demonstrated by a strong correlation and a slope/intercept close to the ideal (slope of 1, intercept of 0) for method comparison.
| Metric | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Serum/Plasma Comparison) |
|---|---|---|
| Slope | Close to 1 (e.g., 0.95 - 1.05) | 1.17 |
| Intercept | Close to 0 | 1.6 |
| Correlation Coefficient | High (e.g., ≥ 0.95 or 0.975) | 0.976 |
| Range of Samples | Not explicitly defined as a criterion for equivalence | 0 - 113.1 ng/mL |
Note: The "Acceptance Criteria" here are inferred based on typical expectations for method comparison studies to demonstrate substantial equivalence for a new sample type. The document does not explicitly state what ranges were considered acceptable prior to the study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 160 samples (referred to as "rats" in the table, which is highly likely a typo and should be "runs" or "samples"). Given the context of human serum and plasma, it's virtually certain these were human samples and not from actual rats.
- Data Provenance: The document does not specify the country of origin. The study was conducted as a comparison study between serum and heparinized plasma, supporting the market expansion. It is implied to be a prospective collection for the purpose of this comparison, although not explicitly stated as prospective or retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of submission, pertaining to a sample matrix expansion for an in vitro diagnostic (IVD) assay, does not typically involve expert review for ground truth in the way a diagnostic imaging device might. The "ground truth" for the test set is established by the measurements themselves using the existing, cleared assay on serum, and comparing those to measurements on heparinized plasma. The experts involved would be the laboratory personnel performing the assays, whose qualifications are not detailed but are assumed to be standard for a clinical laboratory.
4. Adjudication Method for the Test Set
Not applicable. This is not a study comparing human performance or interpretations, but rather an analytical comparison of an IVD assay's performance on different sample types.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is an analytical performance study comparing the assay's results across different sample matrices, not a study of human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" analytical performance evaluation was performed. The Stratus® CK-MB Fluorometric Enzyme Immunoassay is an automated in vitro diagnostic test. The study evaluates the performance of this assay (the "algorithm/device") directly on different sample types without human interpretive intervention beyond running the test and analyzing the numerical output.
7. The Type of Ground Truth Used
The ground truth used for this comparison study is the measurement obtained from human serum samples using the already cleared Stratus® CK-MB assay. The heparinized plasma samples are then compared against these serum measurements to demonstrate equivalence. Essentially, the "ground truth" is the established measurement performance on the original, cleared sample type.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" in the context of this submission. This is not a machine learning model, but rather an analytical device. The "training" for such a device involves its initial development and validation, which occurred prior to this 510(k) submission (for the original serum clearance).
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of this submission. For an IVD, the initial "ground truth" during development involves rigorous analytical validation (e.g., accuracy, precision, linearity, interference, limit of detection) against reference methods or known concentrations, and then clinical correlation studies. The details of this prior validation are not part of this specific 510(k) submission which focuses on a sample type expansion.
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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 | CorrelationCoefficient | Range ofSamples | |
|---|---|---|---|---|
| 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
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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
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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
0000000
§ 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.