(32 days)
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Not Found
No
The description focuses on standard immunoassay technology and optical measurement, with no mention of AI or ML terms or concepts.
No
This device is an in vitro diagnostic product used to measure myoglobin, which aids in the diagnosis of diseases. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is an "in vitro diagnostic product for the measurement of myoglobin in heparinized plasma" and that these measurements "are used as aids in the rapid diagnosis of renal or heart disease".
No
The device description clearly states it is an "in vitro diagnostic product" and describes a "two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology" and an "optical system". These are descriptions of physical components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / 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.
Product codes
DDR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
A split sample comparison study was conducted between the two systems with the following results: n=203, Slope=0.97, Intercept=8, Correlation Coefficient=0.987. Range of Samples: 15 - 829 ng/mL.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A split sample comparison study was conducted between the two systems with the following results: n=203, Slope=0.97, Intercept=8, Correlation Coefficient=0.987. Myoglobin concentration range of samples: 15 - 829 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
3
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