(53 days)
Not Found
No
The device description details a standard chemical assay and does not mention any AI or ML components. The performance studies are based on correlation with a predicate device, not on training or testing of an AI/ML model.
No
The device is an in vitro diagnostic device used to measure total iron binding capacity, which aids in diagnosis and treatment, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders."
No
The device description clearly outlines a chemical assay involving reagents and a clinical chemistry system, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.
Product codes
JMO
Device Description
The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.
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)
Split sample comparison between the IBCT Flex® reagent cartridge and TIBC Flex® reagent cartridges on the Dimension® clinical chemistry system gave a correlation coefficient of 0.971, slope of 1.14, and an intercept of -22.4 ug/dL when tested with 137 clinical patient samples ranging from 59 to 469 ug/dL TIBC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.971, slope of 1.14, and an intercept of -22.4 ug/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general 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
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string is "K994115". The characters are written in a simple, clear style, making them easily readable. The image appears to be a close-up of the string, possibly extracted from a larger document or label.
JAN 2 8 2000
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: | Total Iron Binding Capacity (IBCT) Flex® reagent cartridge |
| FDA Classification Name: | Iron Binding Capacity Test System |
| Predicate Device: | Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230) |
Device Description: The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.
Intended Use: The Total Iron Binding Capacity (1BCT) Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure total iron binding capacity in human serum and plasma.
Comparison to Predicate Device:
| Item | IBCT Flex® reagent cartridge | TIBC Flex® reagent cartridge |
|---|---|---|
| Sample Type | serum and plasma | serum |
| Methodology | Photometric measurement | Pretreatment step, followed by |
| Photometric measurement | ||
| Detection | Bichromatic endpoint | |
| (600 and 700 nm) | Bichromatic endpoint | |
| (600 and 700 nm) |
Comments on Substantial Equivalence: Split sample comparison between the IBCT Flex® reagent cartridge and TIBC Flex® reagent cartridges on the Dimension® clinical chemistry system gave a correlation coefficient of 0.971, slope of 1.14, and an intercept of -22.4 ug/dL when tested with 137 clinical patient samples ranging from 59 to 469 ug/dL TIBC.
The IBCT Flex® reagent cartridge is substantially equivalent in principle and performance to the TIBC Conclusion: Flex® reagent cartridge based on the comparison discussed abo
Robin Orner
Robin O. Norris Manager, Quality Assurance and Compliance December 2, 1999
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 8 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: K994115
Trade Name: Total Iron Binding Capacity Flex® Reagent Cartridge Regulatory Class: I reserved Product Code: JMO 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 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 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
3
Indications For Use Statement
Device Name: Total Iron Binding Capacity Flex® reagent cartridge
Indications for Use:
The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.
Jean Cooger
(Division Sign-Off)
510(k) Number
Robin O'nomis
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
(Optional format 1-2-96)