(17 days)
The MYO method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to quantitatively measure myoglobin in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.
The MYO method for the Dimension® RxL system with the heterogeneous immunoassay module is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles (CrO-) coated with monoclonal antibodies specific for myoglobin and conjugate reagent (ß-galactosidase labeled monoclonal antibodies specific for myoglobin). A particle/MYO/coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with the chromogenic substrate chlorophenol redß-d-galactopyranoside (CPRG) and catalyzes the hydrolysis of CPRG to the chromophore, chlorophenol red (CPR). The concentration of MYO present in the patient sample is directly proportional to the rate of color change measured at 577nm due to formation of CPR.
This submission describes the Myoglobin Flex™ reagent cartridge for the Dimension® RxL system, intended for quantitative measurement of myoglobin in human serum and plasma to aid in the rapid diagnosis of acute myocardial infarction. The study performed is a split sample comparison against a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (vs. Predicate) |
|---|---|
| Good correlation coefficient | 0.992 |
| Slope close to 1.0 | 1.04 |
| Intercept close to 0 | -4.15 ng/mL |
Note: The document does not explicitly state pre-defined acceptance criteria. The "Conclusion" section implies that the reported performance metrics (correlation, slope, intercept) were considered sufficient to demonstrate substantial equivalence to the predicate device.
2. Sample Size and Data Provenance
- Sample Size for Test Set: 204 clinical patient samples.
- Data Provenance: Not explicitly stated, but the samples are described as "clinical patient samples," suggesting they were collected from human subjects. The country of origin and whether the data was retrospective or prospective are not provided.
3. Number of Experts and Qualifications for Ground Truth
The study does not involve expert readers to establish ground truth in the traditional sense of image interpretation. It's a quantitative immunoassay comparison. The "ground truth" for the test set is established by the measurements obtained from the predicate device, the Stratus® Myoglobin assay. Therefore, the concept of expert consensus or qualifications of experts for ground truth is not applicable here.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative assay comparison, not a study involving human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This study does not involve human readers interpreting cases, and therefore, no MRMC study was performed. The comparison is between two automated assay systems.
6. Standalone Performance Study
Yes, in a way, the study demonstrates the standalone performance of the Myoglobin Flex™ reagent cartridge relative to the predicate device. The performance metrics (correlation, slope, intercept) directly reflect how the new device performs on its own when measuring myoglobin in patient samples, as compared to an already established method. There is no human-in-the-loop component for these quantitative measurements.
7. Type of Ground Truth Used
The "ground truth" for the comparison study was effectively the measurements obtained from the predicate device, the Stratus® Myoglobin Fluorometric Enzyme Immunoassay. The new device's performance was evaluated by how closely its results aligned with those from the predicate device on the same samples.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or machine learning model. This is an immunoassay, and its development would typically involve reagent formulation, optimization, and validation, rather than machine learning training.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or ground truth establishment relevant to an algorithm development in this context. The "training" of such a device primarily involves optimizing its chemical and enzymatic reactions and calibration, not a data-driven model.
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DADE BEHRING INC. P O. Box 6101 Newark DE 19714
Dade Behring
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.
Rebecca S. Ayash Submitter's Name: Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, DE 19714-6101
Date of Preparation: 11/20/98
Device Name: Myoglobin Flex™ reagent cartridge
Classification Name: Myoglobin Immunological Test System
Predicate Device: Stratus® Myoglogobin Fluorometric Enzyme Immunoassay
Device Description: The MYO method for the Dimension® RxL system with the heterogeneous immunoassay module is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles (CrO-) coated with monoclonal antibodies specific for myoglobin and conjugate reagent (ß-galactosidase labeled monoclonal antibodies specific for myoglobin). A particle/MYO/coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with the chromogenic substrate chlorophenol redß-d-galactopyranoside (CPRG) and catalyzes the hydrolysis of CPRG to the chromophore, chlorophenol red (CPR). The concentration of MYO present in the patient sample is directly proportional to the rate of color change measured at 577nm due to formation of CPR.
Intended Use: The Myoglobin (MYO) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure myoglobin (MYO) in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.
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Comparison to Predicate Device:
| ltem | Dimension® RxL MYO | Stratus® Myoglobin |
|---|---|---|
| Technology | Sandwich format monoclonalantibody immunoassay | Sandwich format monoclonalantibody immunoassay |
| Detection | Colorimetric rate measurementat 577 nm and 700nm | Front surface fluorometrymeasurement |
| Solid Support | Chrome | Glass fiber paper |
| Specimen Type | Serum or plasma | Serum or plasma |
| Intended Use | For the quantitativedetermination of myoglobin inserum and plasma | For the quantitativedetermination of myoglobin inserum and plasma |
| Indications for Use | To aid in the rapid diagnosis ofacute myocardial infarction | To aid in the rapid diagnosis ofacute myocardial infarction |
Comments on Substantial Equivalence: Split sample comparison between the MYO method on the Dimension® RxL system and the Stratus® Myoglobin assay gave a correlation coefficient of 0.992, slope of 1.04, and an intercept of -4.15 ng/mL when tested with 204 clinical patient samples ranging from 10 -- 1000 ng/mL.
Conclusion: The MYO Method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Stratus ® Myoglobin assay based on the split sample comparison summarized above.
Rebecca S. Ayash
Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 11/20/98
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 0 1998
Ms. Rebecca Ayash Requlatory Affairs & Compliance Manager Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714
K984191 Re : Myoglobin Flex Reagent Cartridge Trade Name: Requlatory Class: II Product Code: DDR Dated: November 20, 1998 Received: November 23, 1998
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 Requlations, 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 requlatory 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.
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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 requlation 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 Sutman
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: Myoglobin (MYO) Flex™ reagent cartridge
Indications for Use: The MYO method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to quantitatively measure myoglobin in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.
Rebecca S. Cupsh
Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 11/20/98
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Concurrence of CDRH, Office of Device Evaluation (ODE)
K984191
510(k) Number
At. An Awm
ision Sian-Off Office of Device Evaluation
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§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).