(21 days)
Dade Behring Stratus® Myoglobin Calibrator
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No
The summary describes a calibrator solution for a clinical chemistry system, which is a chemical reagent product, not a software or hardware device that would typically incorporate AI/ML. There is no mention of AI, ML, or related concepts in the description or the "Mentions AI, DNN, or ML" section.
No
The device is a calibrator used to ensure the accuracy of a clinical chemistry system, not to directly treat or diagnose a patient.
No
This device is a calibrator used to calibrate a clinical chemistry system, not a diagnostic device itself. It helps ensure the accuracy of assays performed by the diagnostic system.
No
The device description clearly states it is a "liquid bovine serum albumin-based product" and a "kit consists of ten vials," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for calibrating a "clinical chemistry system" and a "heterogeneous immunoassay module." These are systems used to perform in vitro diagnostic tests on patient samples.
- Device Description: The device is a "liquid bovine serum albumin-based product" containing "human heart myoglobin." This describes a reagent used in a laboratory setting to calibrate an assay that measures a substance (myoglobin) in a biological sample.
- Predicate Device: The predicate device listed is a "Myoglobin Calibrator," which is a common type of IVD product used for calibrating myoglobin assays.
These characteristics clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The MYO Calibrator is intended to be used to calibrate the MYO Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Product codes
JIT
Device Description
MYO Calibrator is a five level liquid bovine serum albumin-based product with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 contains no detectable myoglobin. Levels 2 through 5 contain human heart myoglobin. The kit consists of ten vials; two at each level
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Dade Behring Stratus® Myoglobin Calibrator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
DADE BEHRING K984193
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.
| Submitter's Name: | Rebecca S. Ayash |
|---|---|
| Dade Behring Inc. | |
| Building 500, Mailbox 514 | |
| P.O. Box 6101 | |
| Newark, DE 19714-6101 | |
| Phone: | (302) 631-6276 |
| FAX: | (302) 631-6299 |
Date of Preparation: 11/20/98
Device Name: Dimension® RxL Myoglobin (MYO) Calibrator
Classification Name: Calibrator, secondary
Dade Behring Stratus® Myoglobin Calibrator Predicate Device:
Device Description: MYO Calibrator is a five level liquid bovine serum albumin-based product with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 contains no detectable myoglobin. Levels 2 through 5 contain human heart myoglobin. The kit consists of ten vials; two at each level
Intended Use: The MYO Calibrator is intended to be used to calibrate the MYO Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Comparison to Predicate Device:
| Dimension® RxL MYO Calibrator | Stratus® Myoglobin Calibrator | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human heart myoglobin | Human heart myoglobin |
| Matrix | Bovine serum albumin | Bovine serum albumin |
| Form | Liquid | Liquid |
| Target | ||
| Concentrations | ||
| (ng/mL) | 0, 35, 100, 500, 1060 | 0, 35, 100, 300, 500, 1000 |
| Levels | Five | Six |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing snakes intertwined around a staff. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 1998 Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade Behring Buildinq 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re: K984193 Dimension® RxL Myoglobin (MYO) Calibrator Trade Name: Requlatory Class: II Product Code: JIT 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 leqally 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 Regulations, 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 regulatory 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 obliqation 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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Paqe 2
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/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 Radioloqical Health
Enclosure
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Indications Statement
Device Name: Dimension® RxL Myoglobin (MYO) Calibrator
Indications for Use: The Dimension® RxL Myoglobin (MYO) Calibrator is intended to be used to calibrate the Myoglobin Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Rebecca Suysh
Rebecca S. Ayash
Rebecca S. Ayast Regulatory Affairs and Compliance Manager Date: 11/20/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K984193
510(k) Number
0(k) Number
Division Sign-Off
Office of Device Evatuation
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