(45 days)
Not Found
No
The summary describes a calibrator for a clinical chemistry system, which is a standard laboratory reagent, and contains no mention of AI or ML.
No
The device is described as a calibrator for a clinical chemistry system, intended for use by laboratory personnel to calibrate an instrument, not for direct treatment or diagnosis of a patient.
No
This device is a calibrator for a clinical chemistry system, meaning it is used to ensure the accuracy of the system's measurements, not to directly diagnose a condition.
No
The device description explicitly states it is a "liquid protein based product" and a "kit consisting of six vials," indicating it is a physical, chemical calibrator, 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 for a specific method (total iron binding capacity - IBCT). This calibration is essential for ensuring the accuracy of diagnostic tests performed on patient samples.
- Device Description: It's a liquid protein-based product used in a clinical laboratory setting.
- Intended User/Care Setting: It's used by clinical laboratory personnel on a clinical chemistry system.
- Predicate Device: The mention of a predicate device (K863840; Dimension® IRN/TIBC Calibrator) which is also a calibrator for a clinical chemistry system strongly suggests this device falls under the same regulatory category, which for these types of products is IVD.
Calibrators for clinical chemistry systems are considered IVDs because they are used to establish the relationship between the signal measured by the instrument and the concentration of the analyte in a patient sample. This relationship is crucial for obtaining accurate diagnostic results.
N/A
Intended Use / Indications for Use
The Dimension® IBCT Calibrator is intended to be used to calibrate the Total Iron Binding Capacity (IBCT) method on the Dimension® clinical chemistry system.
The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.
Product codes
JIS
Device Description
The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each of three levels.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Dimension® IRN/TIBC Calibrator, K863840
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
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
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: | Robin O. Norris |
|---|---|
| Dade Behring Inc. | |
| P.O. Box 6101 | |
| Newark, DE 19714-6101 | |
| Date of Preparation: | December 2, 1999 |
| Name of Product: | Dimension® IBCT Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Dimension® IRN/TIBC Calibrator, K863840 |
Device Description: The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each of three levels.
Intended use: The Dimension® IBCT Calibrator is intended to be used to calibrate the Total Iron Binding Capacity (IBCT) method on the Dimension® clinical chemistry system.
Comparison to Predicate Devices
| Item | Dimension® IRN/TIBC Calibrator | Dimension® IBCT Calibrator |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | iron | human transferrin |
| Matrix | aqueous solution | protein based solution |
| Form | liquid | liquid |
| Volume | 1.0 mL per ampule | 1.0 mL per vial |
| Levels | 3 levels | 3 levels |
| Reference | Primary standard -- | |
| NIST Iron Standard SRM 937 | Primary standard -- | |
| NIST Iron Standard SRM 937 |
Comments on Substantial Equivalence: Both the Dimension® IRN/TIBC Calibrator and the Dimension® IBCT Calibrator are intended to be used as calibrators for total iron binding capacity methods.
Conclusion: The Dimension® IBCT Calibrator is substantially equivalent to the Dimension® IRN/TIBC Calibrator based on the comparison discussed abd
Robin O. Norris
bin O. Norris Manager, Quality Assurance and Compliance December 2, 1999
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 2000
Ms. Robin O. Norris Manager, Quality Assurance and Compliance Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark. Delaware 19714-6101
Re: K994114
Trade Name: Dimension® IBCT Calibrator Regulatory Class: II Product Code: JIS Dated: December 2, 1999 Received: December 6, 1999
Dear Ms. Norris:
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 legally 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 OS 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 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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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" (21CFR 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 Autman
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 For Use Statement
Device Name: Dimension® IBCT Calibrator
Indications for Use:
ω르=================
The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.
Dan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
ivision of Clinical 510(k) Number
Robbi Onons
Robin O. Norris Manager, Quality Assurance and Compliance
December 2, 1999
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ___________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-the-counter Use