(32 days)
The MYO TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.
This myoglobin assay is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.
The information provided describes the Stratus® CS MYO TestPak, an in vitro diagnostic device for measuring myoglobin. The submission focuses on demonstrating substantial equivalence to a previously cleared device, the myoglobin assay performed on the Dade Stratus® analyzer, rather than meeting specific performance acceptance criteria against a defined clinical gold standard.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Substantial Equivalence (Comparison to Predicate Device) | Correlation Coefficient (r): High correlation between the new device and the predicate device. | 0.987 | This value indicates a very strong positive linear relationship between the measurements from the Stratus® CS MYO TestPak and the Dade Stratus® analyzer. |
| Slope of Regression Line: Ideally close to 1. | 0.97 | A slope close to 1 indicates that, on average, the new device measures values very similarly to the predicate device, with minimal proportional bias. | |
| Intercept of Regression Line: Ideally close to 0. | 8 | An intercept of 8 suggests a small constant bias where the new device might read slightly higher than the predicate across the measured range. | |
| Measuring Range: Demonstrated performance across a relevant concentration range. | 15 - 829 ng/mL | The study covered a broad and clinically relevant range of myoglobin concentrations. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 203 unique samples (n=203).
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It describes a "split sample comparison study," implying prospective collection where each sample was split and analyzed on both devices simultaneously, but this is not explicitly confirmed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this particular submission, the "ground truth" for the test set was not established by human experts in the classical sense. Instead, the predicate device (Dade Stratus® analyzer) served as the reference method against which the new device's performance was compared for analytical equivalence.
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Adjudication method for the test set:
- Not Applicable. Since the "ground truth" was derived from the predicate device's analytical results, there was no expert adjudication process.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is an in vitro diagnostic device for measuring a biomarker (myoglobin) and does not involve human readers interpreting images or data where AI assistance would be relevant. The study focuses on analytical performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance presented is for the Stratus® CS MYO TestPak acting independently to measure myoglobin concentrations. While a human initiates the test and interprets the final numerical result, the "performance" described here (correlation, slope, intercept) is purely analytical and automated by the device. It's a "standalone" analytical performance against a predicate device.
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The type of ground truth used:
- The "ground truth" for this substantial equivalence study was the analytical results obtained from the predicate device (Dade Stratus® analyzer). This is a common approach for IVD devices seeking equivalence where an established method exists.
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The sample size for the training set:
- Not Applicable / Not Explicitly Stated. This submission does not describe a machine learning algorithm that requires a distinct "training set." The device is a "two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology," which relies on biochemical reactions and an optical system, not on "training" in the AI sense.
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How the ground truth for the training set was established:
- Not Applicable. As there is no described training set for an AI/ML algorithm, this question is not relevant to the provided documentation.
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DADE BEHRING
APR 27 1998
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
Stratus® CS MYO TestPak
Summary of Safety and Effectiveness
The MYO TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of myoglobin.
This myoglobin assay is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.
The myoglobin assay performed with the MYO TestPak is substantially equivalent to the myoglobin assay performed on the Dade Stratus® analyzer, which was cleared by the FDA through the 510(k) process. Both methodologies have intended uses and are processed on automated systems which use a fluorescence detection for the determination of myoglobin.
A split sample comparison study was conducted between the two systems with the following results:
| n | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|
| 203 | 0.97 | 8 | 0.987 |
Samples 15 - 829 ng/ mL
Range of
Carolyn K. Henge
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
Date
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized representation of a human figure. The figure is composed of three overlapping profiles, symbolizing the department's focus on health and well-being. The seal is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 7 1998
Carolyn K. George . Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re : K981102 Stratus® CS Myoglobin (MYO) TestPak Requlatory Class: II Product Code: DDR Dated: March 25, 1998 March 26, 1998 Received:
Dear Ms. George:
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 general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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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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 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
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Indications Statement
Stratus® CS Myoglobin (MYO) TestPak Device Name:
Indications for Use: The MYO TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.
Carolyn K. Henge
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
310(k) Number
Division Sign-Off
Division Sign-Off Office of Device Evaluation
prescription use
00000000
§ 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).