(85 days)
Dimension® RxL Troponin I Flex™ Reagent Cartridge
Not Found
No
The description details a standard immunoassay system based on chemical reactions and optical measurement, with no mention of AI or ML components.
No
The device is used to measure cardiac troponin I to aid in the diagnosis and risk stratification, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is used "to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes". This directly indicates a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay system involving reagents, test modules, pipetting, and an optical system for measurement, indicating it is a hardware-based device with associated software for control and data processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is used to measure cardiac troponin I in serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes. This involves testing samples taken from the human body in vitro (outside the body) to provide information for diagnostic purposes.
- Device Description: The description details a laboratory-based immunoassay process that involves reacting patient samples with reagents on a test module and measuring the results with an instrument. This is a typical description of an in vitro diagnostic test.
- Sample Type: The assay uses serum and heparinized plasma, which are biological samples taken from a patient.
Therefore, based on the provided information, the Opus™ Troponin I (cTn) assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Troponin I (cTn) assay for the Opus™ Immunoassay System is used to quantitatively measure cardiac troponin I in serum and heparinized 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.
Product codes
MMI
Device Description
The Opus™ Troponin I (cTn) assay is a two-site or sandwich fluorogenic enzyme linked immunoassay. Dendrimer linked monoclonal antibody is precoated onto a piece of glass fiber paper in the cTn Test Module. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule.
The OpusTM System pipettes patient sample from a sample cup and dispenses it onto the glass fiber paper where it reacts with immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted from a sealed well within the test module, onto the reaction zone of the paper. During a second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibodyantigen-labeled antibody sandwich. A substrate wash solution is pipetted from a second sealed well on the test module, to the wash port. Unbound labeled antibody is eluted away from the optical read window of the Opus™ System through lateral capillary action. The substrate, 4-methylumbelliferyl phosphate is included within the wash solution allowing simultaneous substrate conversion with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by the instrument's optical system.
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 Opus™ c Tn assay and the Dimension® RxL Troponin I assay gave a correlation coefficient of 0.9856, slope of 1.01 and an intercept of 0.1516 ng/mL when tested with 132 clinical patient samples ranging from 0.16 - 45.95 ng/mL.
Key Metrics
Correlation coefficient of 0.9856, slope of 1.01 and an intercept of 0.1516 ng/mL.
Predicate Device(s)
Dimension® RxL Troponin I Flex™ Reagent Cartridge
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.
0
JUL - 1 1999
K 991177
DADE BEHRING
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
. . . . . . . . . . . . . .
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 Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, DE 19714-6101 Phone: (302) 631-6276 FAX: (302) 631-6299
Date of Preparation: 4/6/99
/
Device Name: Opus™ Troponin I (cTn) Test Modules
Classification Name: Immunoassay Method, Troponin Subunit
Predicate Device: Dimension® RxL Troponin I Flex™ Reagent Cartridge
Device Description: The Opus™ Troponin I (cTn) assay is a two-site or sandwich fluorogenic enzyme linked immunoassay. Dendrimer linked monoclonal antibody is precoated onto a piece of glass fiber paper in the cTn Test Module. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule.
The OpusTM System pipettes patient sample from a sample cup and dispenses it onto the glass fiber paper where it reacts with immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted from a sealed well within the test module, onto the reaction zone of the paper. During a second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibodyantigen-labeled antibody sandwich. A substrate wash solution is pipetted from a second sealed well on the test module, to the wash port. Unbound labeled antibody is eluted away from the optical read window of the Opus™ System through lateral capillary action. The substrate, 4-methylumbelliferyl phosphate is included within the wash solution allowing simultaneous substrate conversion with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by the instrument's optical system.
Intended Use: The Troponin I (cTn) assay for the Opus™ Immunoassay System is used to quantitatively measure cardiac troponin I in serum and heparinized plasma to aid in the
1
diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
| Item | Opus™ Troponin I | Dimension® RxL Troponin I |
|---|---|---|
| Principle of procedure | Sandwich format monoclonal antibody immunoassay | Sandwich format monoclonal antibody immunoassay |
| Monoclonal Antibodies | ||
| TagCapture | 2B1.92F6.6 | 2B1.92F6.6 |
| Type of measurement | Fluorogenic | Colorimetric |
| Solid Support | Glass fiber paper | Chromium Oxide |
| Specimen type | serum or heparinized plasma | serum or heparinized plasma |
| Sample Size | 25µL | 60µL |
| Intended Use | For the quantitative determination of cardiac troponin-I levels in serum and heparinized plasma | For the quantitative determination of cardiac troponin-I levels in serum and heparinized 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 Opus™ c Tn assay and the Dimension® RxL Troponin I assay gave a correlation coefficient of 0.9856, slope of 1.01 and an intercept of 0.1516 ng/mL when tested with 132 clinical patient samples ranging from 0.16 - 45.95 ng/mL.
Conclusion: The Opus™ Troponin assay is substantially equivalent in principle and performance to the Dimension® RxL Troponin I assay based on the split sample comparison summarized on the previous page.
Rebecca S. Aypsh
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99
2
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 eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 1 1999
Ms. Rebecca S. Avash Regulatory Affairs and Compliance Manager DADE BEHRING INC. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714
Re: K991177
Trade Name: Opus™ Troponin I (cTn) Test Modules Regulatory Class: II Product Code: MMI Dated: June 15, 1999 Received: June 17, 1999
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 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 action. In addition, FDA may publish further announcements 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.
3
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 regulation (21 CFR Part 801 and addition ally 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/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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
4
Indications Statement
Device Name: Opus™ Troponin I (cTn) Test Modules
Indications for Use: The Troponin I (cTn) assay for the Opus™ Immunoassay System is a device used to measure cardiac troponin I in serum and heparinized 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K-991171
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
eantoos
Division Sign-Off Office of Device Evaluation
Prescription Use