(20 days)
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Not Found
No
The document describes a calibrator for an in vitro diagnostic device, which is a physical product used for calibration and does not involve software or algorithms that would typically incorporate AI/ML. The document explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is an in vitro diagnostic product intended to calibrate another device for measuring myoglobin values, not to treat a condition or provide therapy.
No
Explanation: The device is described as an "in vitro diagnostic product used to calibrate the myoglobin method." It establishes a point of reference for determining myoglobin values, meaning it is a calibrator, not a diagnostic device itself.
No
The device description explicitly states it is a liquid product contained within a plastic cartridge, indicating it is a physical, hardware-based device, not software only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states it is an "in vitro diagnostic product" used to calibrate a method on an analyzer. It's intended to establish a reference point for determining myoglobin values.
- Device Description: Also states it is an "in vitro diagnostic product". It's a reagent used in a laboratory setting to interact with a sample (implied, as it's used for calibration on an analyzer).
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a calibrator and not directly analyzing a patient sample, it is an essential component of an IVD system (the Stratus® CS STAT fluorometric analyzer and the myoglobin method) and is used in vitro (outside the body) to ensure the accuracy of the diagnostic results.
N/A
Intended Use / Indications for Use
The MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of myoglobin values.
Product codes
JIT
Device Description
The Stratus® CS MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. The MYO CalPak is a liquid, buffered bovine protein matrix product with myoglobin at an approximate concentration of 850 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.
Mentions image processing
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stratus® myoglobin calibrator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
1981101 DADE BEHRING
APR 1 5 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 CalPak
Summary of Safety and Effectiveness
The Stratus® CS MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer.
The MYO CalPak is a liquid, buffered bovine protein matrix product with myoglobin at an approximate concentration of 850 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.
The MYO CalPak is substantially equivalent to the Stratus® myoglobin calibrator as they are both intended to be used as calibrators for similar myoglobin methods.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
Date
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three overlapping profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 5 1998
Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re: K981101 Stratus® CS MYO CalPak Regulatory Class: II Product Code: JIT Dated: March 25, 1998 Received: March 26, 1998
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 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. ਰ 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 In addition, FDA may publish further announcements action. 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.
2
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 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 Bitman
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
Device Name: Stratus® CS MYO CallPak
Indications for Use: The MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of myoglobin values.
Carolyn K. George
Carolyn K. George
Regulatory Affairs and Compliance Manager
March 25, 1998
Date
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K 98/1101
510(k) Number
Division Sign-Off
Office of Device Evaluation
prescription use
0000000