(66 days)
The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI)
The AxSYM Troponin-I ADV Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of cardiac troponin-I in human serum or plasma.
The AxSYM Troponin-I ADV Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM System (reagents, calibrators, and instrument) when used for the quantitative measurement of cardiac troponin-l in human serum or plasma.
The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunassay for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV assay is calibrated with AxSYM Troponin-I ADV Standard Calibrators. AxSYM Troponin-I ADV Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
Acceptance Criteria and Study for Abbott AxSYM® Troponin-I ADV Assay
This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Abbott AxSYM® Troponin-I ADV assay to the legally marketed predicate device, the Beckman Coulter™ Access® AccuTnI assay.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the substantial equivalence claim relies on a correlation analysis between the new device and a predicate device. The acceptance criteria are implicitly defined by the demonstration of a strong correlation (high R-value) and a slope close to 1, with an intercept close to 0, which would indicate similar measurements between the two assays. While explicit numerical thresholds for acceptance (e.g., minimum R, range for slope and intercept) are not provided, the reported performance is presented to demonstrate this similarity.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Abbott AxSYM® Troponin-I ADV vs. Beckman Coulter™ Access® AccuTnI) |
|---|---|---|
| Correlation (R) | High (close to 1) | 0.97 (All Specimens) 0.95 (ADV Dynamic Range) |
| Slope | Close to 1.0 | 1.47 (All Specimens) 1.47 (ADV Dynamic Range) |
| Intercept | Close to 0.0 | -0.05 (All Specimens) -0.05 (ADV Dynamic Range) |
Note: The reported slope of 1.47 indicates a potential systematic difference where the Abbott AxSYM® device may be reading higher values than the predicate device. However, the FDA has deemed this acceptable for substantial equivalence in this context.
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- All Specimens: 546
- ADV Dynamic Range: 531
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it is generally expected that studies are conducted with specimens from human sources, and frequently these are done through clinical studies in a prospective or mixed fashion, but this specific detail is not provided.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This study is a comparative effectiveness study between two diagnostic devices, not a study evaluating human expert performance against a "true" ground truth in the traditional sense (e.g., identifying disease from an image). The "ground truth" for the comparison is the measurement provided by the legally marketed predicate device, the Beckman Coulter™ Access® AccuTnI assay.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is a direct comparison between two quantitative assays. There is no human adjudication process involved in establishing the "ground truth" (i.e., the predicate device's measurement).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or described. This submission pertains to an in-vitro diagnostic device (an assay), not an imaging device or algorithm designed to be interpreted by human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. Standalone Performance Study
Yes, a standalone performance study was done for the Abbott AxSYM® Troponin-I ADV assay by comparing its measurements directly against an established predicate device. The results of this comparison (correlation, slope, intercept) demonstrate the standalone performance of the algorithm (assay method). It measures quantitative determination of cardiac troponin-I in human serum or plasma without human intervention in the measurement process itself, beyond sample handling.
7. Type of Ground Truth Used
The "ground truth" in this context is the quantitative measurement provided by the Beckman Coulter™ Access® AccuTnI assay, which is explicitly stated as the predicate device. This is a form of comparative ground truth against an established, legally marketed device.
8. Sample Size for the Training Set
Not applicable. This 510(k) summary describes a device comparison study for market clearance, not an AI or machine learning model development where a training set would be explicitly used to develop the algorithm itself. The AxSYM® Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA), a well-established biochemical assay technology. The reported "n" values (546 and 531) refer to the number of specimens used in the comparability study, which serves as the "test set" for demonstrating substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML algorithm being developed. For the development of the assay itself (e.g., establishing its reagents, calibration, and measurement principles), extensive internal R&D and validation would have occurred. However, the 510(k) submission focuses on the clinical performance comparison against a predicate for regulatory clearance.
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510(k) Summary Abbott AxSYM® Troponin-I ADV
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott AxSYM Troponin-I ADV constitutes data supporting a substantially equivalent determination.
The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunassay for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV assay is calibrated with AxSYM Troponin-I ADV Standard Calibrators. AxSYM Troponin-I ADV Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
Substantial equivalence has been demonstrated between the AxSYM Troponin-I ADV assay and the Beckman Coulter™ Access® AccuTnI assay. The intended use of the AxSYM Troponin-I ADV assay is for the quantitative determination of cardiac troponin-I in human serum or plasma. The intended use of the Beckman Coulter Access Accu TnI assay is for the quantitative determination of cardiac troponin I in human serum and plasma. A correlation analysis between the two assavs vielded the following results.
| Regression Method | n | R | Slope | Intercept |
|---|---|---|---|---|
| Passing-Bablok(All Specimens) | 546 | 0.97 | 1.47 | -0.05 |
| Passing-Bablok(ADV Dynamic Range) | 531 | 0.95 | 1.47 | -0.05 |
n = number of specimens
r = correlation coefficient
In conclusion, these data demonstrate that the AxSYM Troponin-I ADV assay is as safe and effective as, and is substantially equivalent to, the Beckman Coulter Access AccuTnI assay.
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Prepared and Submitted 31 August 2004 by:
Margaret Prochniak, M.S. Senior Regulatory Specialist ADD Regulatory Affairs Phone: (847) 937-4106 Fax: (847) 937-9616 E-mail: Margaret.Prochniak@abbott.com
Abbott Laboratories Diagnostics Division Department 9V6, Building AP6C-3 100 Abbott Park Road Abbott Park, IL 60064-6095
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 0 2004
Ms. Margaret Prochniak, M.S Sr. Regulatory Affairs Specialist Abbott Laboratories Diagnostics Division Dept. 9V6, Bldg. AP6C-3 100 Abbott Park Road Abbott Park, IL 60064-6095
K041811 Re:
Trade/Device Name: Abbott AxSYM® Troponin-I ADV Abbott AxSYM® Troponin-I ADV Standard Calibrators Abbott AxSYM® Troponin-I ADV Controls Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT, JJX, Dated: July 2, 2004 Received: July 6, 2004
Dear Ms. Prochniak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Jean M. Cooper US. DVM.
Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 1
Indications for Use
510(k) Number (if known): K041811
Device Name: Abbott AxSYM® Troponin-I ADV Abbott AxSYM® Troponin-I ADV Standard Calibrators Abbott AxSYM® Troponin-I ADV Controls
Indications For Use:
The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI)
The AxSYM Troponin-I ADV Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of cardiac troponin-I in human serum or plasma.
The AxSYM Troponin-I ADV Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM System (reagents, calibrators, and instrument) when used for the quantitative measurement of cardiac troponin-l in human serum or plasma.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041811
§ 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.