(25 days)
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No
The summary describes a quantitative measurement kit for total iron-binding capacity using a chemical method, with no mention of AI or ML.
No
The device is intended for in vitro diagnostic use only to quantitatively measure total iron-binding capacity in serum, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as "For in vitro diagnostic use only," explicitly stating its diagnostic purpose. It also quantitatively measures total iron-binding capacity in serum, which is a diagnostic measurement.
No
The device is described as a "Magnetic TIBC Kit" and a "method," which strongly suggests it is a physical kit containing reagents and potentially other hardware components for performing an in vitro diagnostic test, not a software-only device. The performance studies describe a correlation between this "method" and a "microcolumn method," further indicating a laboratory-based, physical testing process.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.
Product codes
75 JMO
Device Description
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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
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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
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Summary of Performance Studies
A correlation between the Magnetic TIBC method and the J & S microcolumn method was obtained using a total of 103 samples. The following relationship was obtained: y = 1.02x - 5.7 with a correlation of 0.99
Key Metrics
correlation of 0.99
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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2/16/99
SUMMARY OF SAFETY AND EFFECTIVENESS
A comprehensive evaluation was performed between the Magnetic TIBC Kit and the predicate device to determine if they are substantially equivalent
A correlation between the Magnetic TIBC method and the J & S microcolumn method was obtained using a total of 103 samples. The following relationship was obtained:
・・・・
y = 1.02x - 5.7 with a correlation of 0.99
Based upon this information, Reference Diagnostics, Inc. believes that the Magnetic TIBC Kit is substantially equivalent to the J & S Microcolumn and Iron Saturating reagent kit for TIBC.
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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 image of three human profiles facing right, with flowing lines beneath them. The profiles and lines are contained within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 16 1999
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 23 Crosby Drive Bedford, MA 01730-1401
Re: K990216 Trade Name: Magnetic TIBC Kit Regulatory Class: I Product Code: 75 JMO Dated: January 21, 1999 Received: January 22, 1999
Dear Dr. Lawlor:
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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 Radiological Health
Enclosure
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Statement of Intended Use
Page 1 of 1
510(k) Number (if known):
Device Name:
Magnetic TIBC Kit
Indications For Use:
For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.
Summary and Explanation of the Test:
Total iron-binding capacity (TIBC) is used to evaluate the cause and progression of anemia. This measurement helps to differentiate between anemia resulting from chronic illness and iron anto (Division Sign-Off) deficiency anemia.
Division of Clinical Laboratory Devices
510(k) Number K990216
(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