(21 days)
K/DEN: Not Found
Not Found
No
The document describes a calibrator for a diagnostic analyzer, which is a chemical reagent product, not a software or imaging device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an "in vitro diagnostic product used to calibrate the CKMB method on the Stratus® CS STAT fluorometric analyzer." It's a calibrator, establishing a point of reference for determining CKMB values, not directly treating a patient.
No
Explanation: This device is a calibrator, an in vitro diagnostic product used to establish a point of reference for a diagnostic method. It is not a diagnostic device itself because it does not directly determine a diagnosis or provide diagnostic information about a patient's condition.
No
The device description clearly states it is a liquid product contained within a plastic cartridge, indicating it is a physical, hardware-based device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB method on the Stratus® CS STAT fluorometric analyzer." This directly identifies it as an IVD.
- Function: The device is used to calibrate an analytical instrument (the Stratus® CS STAT fluorometric analyzer) which is used to determine the concentration of a substance (CKMB) in a biological sample. This is a core function of IVD products – to provide tools and materials for testing samples outside of the body.
- Device Description: The description confirms it's a "liquid, buffered bovine protein matrix product with CKMB," which is a typical format for calibrators used in laboratory testing.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB 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 CKMB values.
Product codes
JIT
Device Description
The Stratus® CS CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB method on the Stratus® CS STAT fluorometric analyzer. The CKMB CalPak is a liquid, buffered bovine protein matrix product with CKMB at an approximate concentration of 135 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
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 (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® CKMB 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
DADE BEHRING
APR 1 6 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 CKMB CalPak
Summary of Safety and Effectiveness
The Stratus® CS CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB method on the Stratus® CS STAT fluorometric analyzer.
The CKMB CalPak is a liquid, buffered bovine protein matrix product with CKMB at an approximate concentration of 135 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.
The CKMB CalPak is substantially equivalent to the Stratus® CKMB calibrator as they are both intended to be used as calibrators for similar CKMB methods.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 24, 1998
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three curved lines forming its body and wings. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 6 1998
Carolyn K. George . Requlatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re: K981097 Stratus® CS CKMB CalPak Regulatory Class: II Product Code: JIT Dated: March 24, 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 The general controls provisions of the Act 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. ਦੇ 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 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.
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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 leqally 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 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
3
Indications Statement
Device Name: Stratus® CS CKMB CalPak
Indications for Use: The CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB 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 CKMB values.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 24, 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
Division Sign-Off Office of Device Evaluation
prescription use
l
0000000