(72 days)
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No
The device description and performance studies describe a standard clinical chemistry assay with no mention of AI or ML techniques.
No
The device is an in vitro diagnostic (IVD) assay used for the quantitative determination of total iron binding capacity (TIBC) in human serum, which is used in the diagnosis and treatment of anemia. It does not directly treat or prevent a disease, but rather provides information for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Iron-binding capacity measurements are used in the diagnosis and treatment of anemia," and the "Device Description" section describes it as an "in vitro diagnostic assay."
No
The device description clearly outlines a clinical chemistry assay involving sample pretreatment with ferric chloride and alumina adsorbent, followed by analysis using Iron reagents. This involves physical components and chemical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is for "quantitation of the total iron binding capacity of human serum" and that these measurements are "used in the diagnosis and treatment of anemia." This clearly indicates a diagnostic purpose performed on a biological sample (human serum).
- Device Description: The description states, "Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum." This directly identifies the device as an in vitro diagnostic assay.
- Performance Studies: The performance studies compare the device to a "predicate device" (although the K number is not provided), which is a common practice for demonstrating substantial equivalence for IVD devices.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
Product codes (comma separated list FDA assigned to the subject device)
75JMO
Device Description
Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum. The TIBC assay is a clinical chemistry assay which involves a sample pretreatment followed by the analysis of TIBC with the Iron reagents. Ferric chloride saturating solution is mixed with the sample to bind all available apotransferrin binding sites with iron. Alumina adsorbent removes excess iron from the mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution by the saturating solution.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET™ Analyzer. The TIBC assay method comparison yielded acceptable correlation with the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System. The correlation coefficient = 0.9896, slope = 0.988, and Y-intercept = 6.790 ug/dL. Precision studies were conducted using the TIBC assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 2.1% and 4.3% for Level 2/Panel 112. The Iron assay is linear up to 1778.5 us/dL. The limit of quantitation (sensitivity) for the Iron assay is 3.8 ug/dL. The calculated TIBC values are acceptable from 11.4 ug/dL to 5335.5 ug/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation coefficient = 0.9896, slope = 0.988, and Y-intercept = 6.790 ug/dL. Precision studies were conducted using the TIBC assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 2.1% and 4.3% for Level 2/Panel 112. The Iron assay is linear up to 1778.5 us/dL. The limit of quantitation (sensitivity) for the Iron assay is 3.8 ug/dL. The calculated TIBC values are acceptable from 11.4 ug/dL to 5335.5 ug/dL.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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K98 1654
510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Jul 22 1998
Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 8, 1998 |
|---|---|
| Device Trade or Proprietary Name: | TIBC |
| Device Common/Usual Name or Classification Name: | TIBC |
| Classification Number/Class: | 75JMO/Class I |
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.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Test Description:
Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum. The TIBC assay is a clinical chemistry assay which involves a sample pretreatment followed by the analysis of TIBC with the Iron reagents. Ferric chloride saturating solution is mixed with the sample to bind all available apotransferrin binding sites with iron. Alumina adsorbent removes excess iron from the mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution by the saturating solution.
TIBC 5100k Mav 8, 1998 TIBCf.JWD
Section II Page 1
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Substantial Equivalence:
The TIBC assay is substantially equivalent to the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System.
Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for sample pretreatment in the quantitative determination . of TIBC.
- Both assays yield similar clinical results. .
Differences:
- There is a difference in the assay range. .
Intended Use:
The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ Analyzer. The TIBC assay method comparison yielded acceptable correlation with the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System. The correlation coefficient = 0.9896, slope = 0.988, and Y-intercept = 6.790 ug/dL. Precision studies were conducted using the TIBC assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 2.1% and 4.3% for Level 2/Panel 112. The Iron assay is linear up to 1778.5 us/dL. The limit of quantitation (sensitivity) for the Iron assay is 3.8 ug/dL. The calculated TIBC values are acceptable from 11.4 ug/dL to 5335.5 ug/dL. These data demonstrate that the performance of the TIBC assay is substantially equivalent to
Section II Page 2
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the performance of the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System.
Conclusion:
The TIBC assay is substantially equivalent to the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System as demonstrated by results obtained in the studies.
IBC 510ck May 8 1998
Section II Page 3
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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
JUL 2 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark Littlefield Section Manager, Requlatory Affairs ABBOTT LABORATORIES 1920 Hurd Drive Irving, TX 75038
Re : K981654 TIBC Trade Name: Regulatory Class: I Product Code: JMO Dated: May 8, 1998 Received: May 11, 1998
Dear Mr. Littlefield:
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 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, Druq, 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 requlations 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 requirement, as set forth in the Quality System Requlation (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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Paqe 2
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 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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510(k) Number (if known): 198165 Y
TIBC Device Name: ____________________
Indications For Use:
The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 981654
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 11 OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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