(50 days)
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No
The device description outlines a standard clinical chemistry assay based on chemical reactions and spectrophotometry, with no mention of AI or ML techniques. The performance studies focus on traditional analytical metrics like correlation, precision, and linearity.
No
The device is an in vitro diagnostic assay used to measure unsaturated iron-binding capacity in serum, which aids in the diagnosis and treatment of anemia. It does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" states that "Iron-binding capacity measurements are used in the diagnosis and treatment of anemia," and the "Device Description" identifies it as an "in vitro diagnostic assay."
No
The device description clearly describes a clinical chemistry assay involving chemical reactions and measurement of color at a specific wavelength, indicating a physical in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is "intended to measure the unsaturated iron-binding capacity in 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 (serum) in vitro (outside the body).
- Device Description: The description further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of the unsaturated iron binding capacity of human serum." It describes the chemical process used to perform the test on the serum sample.
These points directly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Unsaturated Iron Binding Capacity (UIBC) assay is intended to measure the unsaturated iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
Product codes
75JMO
Device Description
Unsaturated Iron Binding Capacity (UIBC) is an in vitro diagnostic assay for the quantitative determination of the unsaturated iron binding capacity of human serum. The UIBC assay is a clinical chemistry assay in which transferrin is saturated by adding a known excess quantity of iron. The free Fe2+ reacts with Nitroso-PSAP forming a chelate compound. The color measured at 760 nm is proportional to the residual iron concentration. Unsaturated iron binding capacity is calculated by taking the iron concentration from a known excess quantity of iron.
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
Comparative performance studies were conducted using the AEROSET™ Analyzer. The UIBC assay method comparison yielded acceptable correlation with the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer. Precision studies were conducted using the UIBC assay. Within-run, between-run, and between-day studies were performed using three levels of control material. The UIBC assay is linear up to 805.2 ug/dL. The limit of quantitation (sensitivity) for the UIBC assay is 46.6 µg/dI.
Key Metrics
correlation coefficient = 0.9976, slope = 1.009, and Y-intercept = 19.863 µg/dL. The total %CV for Level 1/Panel 113 is 6.9%, Level 2/Panel 115 is 9.8% and Level 3/Panel 116 is 3.9%. sensitivity is 46.6 µg/dI.
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.
0
JUL 30 1998
K 982041
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive
Irving, Texas 75038
Contact Person Linda Morris Senior Regulatory Specialist MS 1-6 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | June 9, 1998 |
|---|---|
| Device Trade or Proprietary Name: | UIBC |
| Device Common/Usual Name or Classification Name: | UIBC |
| 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: _ K98904/
Test Description:
Unsaturated Iron Binding Capacity (UIBC) is an in vitro diagnostic assay for the quantitative determination of the unsaturated iron binding capacity of human serum. The UIBC assay is a clinical chemistry assay in which transferrin is saturated by adding a known excess quantity of iron. The free Fe2+ reacts with Nitroso-PSAP forming a chelate compound. The color measured at 760 nm is proportional to the residual iron concentration. Unsaturated iron binding capacity is calculated by taking the iron concentration from a known excess quantity of iron.
UIBC 510(k) June 9, 1998 UIBCf.lwp
Section II Page 1
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Substantial Equivalence:
The UIBC assay is substantially equivalent to the Boehringer Mannheim® UIBC assay on the Hitachi® 717 Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of UIBC. .
- Both assays yield similar clinical results. .
Differences:
- There is a minor difference in the assay range. .
Intended Use:
The Unsaturated Iron Binding Capacity (UIBC) assay is used for the quantitative determination of unsaturated iron binding capacity in serum.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ Analyzer. The UIBC assay method comparison yielded acceptable correlation with the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9976, slope = 1.009, and Y-intercept = 19.863 µg/dL. Precision studies were conducted using the UIBC assay. Within-run, between-run, and between-day studies were performed using three levels of control material. The total %CV for Level 1/Panel 113 is 6.9%, Level 2/Panel 115 is 9.8% and Level 3/Panel 116 is 3.9%. The UIBC assay is linear up to 805.2 ug/dL. The limit of quantitation (sensitivity) for the UIBC assay is 46.6 µg/dI.. These data demonstrate that the performance of the UIBC assay is substantially equivalent to the performance of the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer.
UIBC 510(k) June 9, 1998 UIBCf.lwp
Section II Page 2
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Conclusion:
: .
ﺗ ﻣﺴﻠﺴﻪ
The UIBC assay is substantially equivalent to the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
UIBC 510(k) June 9, 1998
UIBCf.lwp
Section II Page 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the bird figure in the center.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jul 3 0 1998
Mark Littlefield Mark Littlerierd
Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K982041 Re : UIBC Regulatory Class: I Product Code: JMO Dated: June 9 , 1998 Received: June 10, 1998
Dear Mr. Littlefield:
We have reviewed your Section 510(k) notification of intent to We have reviewed your seccion from and we indications for market the device released above (for the indications for device is substancially equivalit (res marketed in interstate use stated in the encrosure, to as a soft ment date of the commerce prior co nay as , or to devices that have been Medical Device Amendments, or to ac-ac-visions of the Pederal reclassified in accordance with one from and therefore, Food, Drug, and Cosmecre her (1100).
market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. of the Act. The general someal registration, listing of Include roquil manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II If your device is crasbiria (Bo(Premarket Approval), it may (Special Concrolo) of Crissal controls. Bxisting major he subject co such addicionary of tound in the code of Federal Requlations, Title 21, Parts 800 to 895. ਸ rederal kegulations, freis si, ination assumes compliance with Substantly equivalence aring Practice requirements, as set the Carrent County System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Ch the GMT regaraction was publish further announcement.s action. concerning your device in the Federal Register. Please note: concerning your devres remarket notification submission does ents responde co your for you might have under sections 531 through 542 of the Act for devices under the Electronic enroagn sadiation Control provisions, or other Federal laws or requlations .
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Page 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 yitro 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. the regulation entitled, "Misbranding by reference to
remarket notification" (21 CFR 807.97) . Other general 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 ox at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Litman
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
5
510(k) Number (if known):
UIBC Device Name:
Indications For Use:
The Unsaturated Iron Binding Capacity (UIBC) assay is intended to measure the unsaturated iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. 2
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 1 OR Over-The-Counter Use (Per 21 CFR 801.109)
th. Lapsala
inical Laboratory Devices 510(k) Number
(Optional Format 1-2-96)