(25 days)
None
Not Found
No
The description details a standard enzyme immunoassay method and does not mention any AI or ML components.
No
This device measures cardiac troponin-I to aid in the diagnosis of myocardial infarction and risk stratification; it does not provide therapy or treatment.
Yes
The device is described as aiding in the "diagnosis of myocardial infarction" and "risk stratification of patients with acute coronary syndromes," which directly indicates its use for diagnostic purposes.
No
The device description clearly outlines a chemical assay method involving reagents, particles, and enzymatic reactions, which are hardware components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the method is used to "quantitatively measure cardiac troponin-1 in human serum and plasma." This is a measurement performed in vitro (outside the body) on a biological sample.
- Purpose: The measurements "aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes." This clearly indicates a diagnostic purpose.
- Device Description: The description details a laboratory-based immunoassay process involving chemical reactions and measurement of a colored product, which is characteristic of an in vitro diagnostic test.
- Sample Type: The test is performed on "human serum and plasma," which are biological samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure cardiac troponin-1 in human serum and plasma. Measurements of TROP aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Product codes
MMI
Device Description
The TROP method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrOz) coated with a monoclonal antibody specific for cardiac troponin-1 and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibody specific for cardiac troponin-I] to form a particle/cardiac troponin-I/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipvrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of cardiac troponin-I present in the patient sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Split sample comparison between the TROP method on the Dimension® RxL clinical chemistry system and the Stratus® cardiac Troponin-I assay gave a correlation coefficient of 0.9918, slope of 1.10 and an intercept of -0.075 ng/mL when tested with 111 clinical patient samples ranging from 0.00 to 47.87 ng/mL.
Key Metrics
Correlation coefficient: 0.9918
Slope: 1.10
Intercept: -0.075 ng/mL
Predicate Device(s)
Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The font appears slightly distressed, giving it a textured look.
OCT 2 0 1997
Image /page/0/Picture/2 description: The image shows the text "K973650" at the top. Below that is a black rectangle with the words "DADE INTERNATIONAL" in white letters. The text is in all caps and is centered within the rectangle. The image appears to be a scan or photocopy of a document.
Chemistry Systems 20 Box 6101 1010. 00 3114
Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Rebecca S. Ayash
Dade International Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101
Phone: (302) 451-0276
FAX: (302) 451-0299 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation:
Device Name: | 9/24/97
Cardiac Troponin-I (TROP) Method |
| Classification Name: | Immunoassay Method, Troponin Subunit |
| Predicate Device: | Stratus® Cardiac Troponin-I Fluorometric Enzyme
Immunoassay |
Device Description: The TROP method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrOz) coated with a monoclonal antibody specific for cardiac troponin-1 and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibody specific for cardiac troponin-I] to form a particle/cardiac troponin-I/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipvrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of cardiac troponin-I present in the patient sample.
Intended Use: The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively
1
Intended Use: The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure cardiac troponin-1 in human serum and plasma. Measurements of TROP aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
| Item | Dimension® RxL TROP | Stratus® Cardiac Troponin-I |
|---|---|---|
| Technology | Sandwich format | |
| monoclonal antibody | ||
| immunoassay | Sandwich format | |
| monoclonal antibody | ||
| immunoassay | ||
| Monoclonal Antibodies | ||
| • Tag | ||
| • Capture | • 2B1.9 | |
| • 2F6.6 | • 2B1.9 | |
| • 2F6.6 | ||
| Detection | Colorimetric rate | |
| measurement at 510nm | ||
| and 700nm | Front surface fluorometry | |
| measurement at 577nm | ||
| and 600nm | ||
| Solid Support | Chrome | Glass fiber paper |
| Specimen type | serum or plasma | serum or plasma |
| Sample Size | 60μL | 100μL |
| Intended Use | For the quantitative | |
| determination of cardiac | ||
| troponin-I levels in serum | ||
| and plasma | For the quantitative | |
| determination of cardiac | ||
| troponin-I levels in serum | ||
| and plasma | ||
| Indications for Use | To aid in diagnosis of | |
| myocardial infarction and | ||
| to aid in the risk | ||
| stratification of patients | ||
| with acute coronary | ||
| syndromes with respect | ||
| to their relative risk of | ||
| mortality | To aid in diagnosis of | |
| myocardial infarction and | ||
| to aid in the risk | ||
| stratification of patients | ||
| with acute coronary | ||
| syndromes with respect | ||
| to their relative risk of | ||
| mortality |
Comparison to Predicate Device:
Comments on Substantial Equivalence: Split sample comparison between the TROP method on the Dimension® RxL clinical chemistry system and the Stratus® cardiac Troponin-I assay gave a correlation coefficient of 0.9918, slope of 1.10 and an intercept of -0.075 ng/mL when tested with 111 clinical patient samples ranging from 0.00 to 47.87 ng/mL.
2
Conclusion: The TROP method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Stratus® Cardiac Troponin-I assay based on the split sample comparison summarized on the previous page.
Rebecca S. Ayash
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 9/24/97
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.
OCT 20 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade International, Inc. Building 500, Mailbox 514 P.O. Box 6101 19714-6101 Newark, Delaware
K973650 Re : Cardiac Troponin-I (TROP) Method Regulatory Class: II Product Code: MMI Dated: September 24, 1997 September 25, 1997 Received:
Dear Ms. Ayash:
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 qeneral 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 requlations 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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Page 2
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 requlation (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
5
Indications Statement
Device Name: Cardiac Troponin-l (TROP) Method
Indications for Use: The TROP method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure cardiac troponin-1 in serum and plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Rebecca S. Ayash
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 9/24/97
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
73650
510(k) Number
Division Sign Off
Division Sign-Off/ Office of Device Evaluation
\ prescription use