(76 days)
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Not Found
No
The summary describes a standard immunoassay for measuring cardiac troponin-I and does not mention any AI or ML components. The performance studies are based on regression analysis, which is a statistical method, not necessarily indicative of AI/ML.
No.
The device is used for the quantitative determination of cardiac troponin-I to assist in diagnosis and risk stratification, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the troponin-I values are "used to assist in the diagnosis of myocardial infarction (MI)".
No
The device description clearly states it is a "Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System." This describes a laboratory assay and the associated hardware system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma". This involves testing biological samples in vitro (outside the body).
- Diagnosis and Risk Stratification: The intended use also states that the results are "used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes". This is a clear diagnostic purpose.
- Device Description: The device description confirms it's a "Microparticle Enzyme Immunoassay (MEIA)", which is a laboratory technique performed on biological samples.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AxSYM Troponin-1 ADV reagent 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) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.
Product codes
MMI
Device Description
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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
Prescription Use
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
Regression Method: Passing-Bablok (All Specimens), n: 546, r: 0.97, Slope: 1.47, Intercept: -0.05
Regression Method: Passing-Bablok (ADV Dynamic Range), n: 531, r: 0.95, Slope: 1.47, Intercept: -0.05
Key Metrics
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Predicate Device(s)
Beckman™ Coulter Access® AccuTnI assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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510(k) Summary
JUN 1 4 2006
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.
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 and plasma to assist in the diagnosis of myocardial infarction, and in the risk stratification of patients with acute coronary syndromes, (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events. The intended use of the Beckman Coulter Access AccuTnI assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin-I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
| 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
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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.
Prepared and submitted 29 March 2006 by:
Margaret Derchinik 3/29/06
Abbott Laboratories Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Dept. 9VA, Bldg AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: (847) 937-4106 Fax: E-Mail: Margaret.Prochniak@abbott.com
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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 features a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9VA AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500
JUN 1 4 2006
Re: K060875
Trade/Device Name: Abbott AxSYM® Troponin-I ADV Reagent Regulation Number: 21 CFR§862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 29, 2006 Received: March 30, 2006
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 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. 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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Indications for Use
510(k) Number (if known):_KOLeO875
Device Name: Abbott AxSYM® Troponin-I ADV Reagent
Indications For Use:
The AxSYM Troponin-1 ADV reagent 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) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.
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 Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060875