(25 days)
For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.
Not Found
The provided document describes a 510(k) submission for the Magnetic TIBC Kit, focusing on its substantial equivalence to a predicate device, the J & S Microcolumn and Iron Saturating reagent kit for TIBC. The evaluation is a correlation study between the two methods rather than a study on a new AI/ML device. Therefore, many of the typical acceptance criteria and study design elements requested, such as human-in-the-loop performance, ground truth establishment for AI, and various expert-related details, are not applicable in this context.
Here's the information that can be extracted or inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Magnetic TIBC Kit vs. J & S microcolumn method) |
|---|---|
| Strong correlation to predicate device | y = 1.02x - 5.7 with a correlation of 0.99 |
2. Sample size used for the test set and the data provenance
- Sample Size: 103 samples
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study is a correlation study between two assay methods and does not involve human expert interpretation for establishing a "ground truth" in the context of an AI/ML device. The "ground truth" for the test set is effectively the results obtained from the predicate device (J & S microcolumn method).
4. Adjudication method for the test set
This information is not applicable as the study design is a direct comparison of analytical measurements from two different laboratory methods, not a study involving human interpretation that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is an in-vitro diagnostic kit, not an AI-powered diagnostic system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm but an in-vitro diagnostic kit. Its performance is evaluated as a standalone analytical method in comparison to another analytical method.
7. The type of ground truth used
The "ground truth" for the purpose of demonstrating substantial equivalence in this context is the results obtained from the predicate device (J & S microcolumn method). The study aimed to show that the new Magnetic TIBC Kit yielded results that were highly correlated with an established, legally marketed method.
8. The sample size for the training set
This information is not applicable. The study described is a direct comparison of analytical methods, not an AI/ML model that requires a distinct training set. The 103 samples were used for the correlation study itself.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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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
§ 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.