UIBC

K982041 · Abbott Laboratories · JMO · Jul 30, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982041
• Device Name: UIBC
• Applicant: Abbott Laboratories
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jul 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

The Unsaturated Iron Binding Capacity (UIBC) assay is used for the quantitative determination of unsaturated iron binding capacity in serum.

Device Story

The UIBC assay is an in vitro diagnostic clinical chemistry test for human serum. The device measures unsaturated iron-binding capacity by saturating transferrin with a known excess of iron; residual free Fe2+ reacts with Nitroso-PSAP to form a chelate compound. The color intensity, measured at 760 nm, is proportional to the residual iron concentration. The assay is performed on clinical chemistry analyzers (e.g., AEROSET™) by laboratory professionals. The resulting UIBC value is used by clinicians to assist in the diagnosis and treatment of anemia.

Clinical Evidence

Bench testing only. Performance studies conducted on the AEROSET™ Analyzer compared to the predicate Hitachi 717 system. Results: correlation coefficient 0.9976, slope 1.009, Y-intercept 19.863 µg/dL. Precision (total %CV) ranged from 3.9% to 9.8% across three control levels. Linearity established up to 805.2 µg/dL; limit of quantitation (sensitivity) is 46.6 µg/dL.

Technological Characteristics

In vitro clinical chemistry assay; colorimetric detection at 760 nm using Nitroso-PSAP reagent. Quantitative measurement of transferrin-bound iron. Operates on automated clinical chemistry analyzers. No specific materials of construction or software algorithms described beyond standard spectrophotometric analysis.

Indications for Use

Indicated for the quantitative determination of unsaturated iron binding capacity in human serum to aid in the diagnosis and treatment of anemia.

Regulatory Classification

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.

Predicate Devices

• Boehringer Mannheim® UIBC assay on the Hitachi® 717 Analyzer

Submission Summary (Full Text)

{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 [phone] Fax [phone]

| 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

{1}------------------------------------------------

## 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

Image /page/1/Picture/15 description: The image contains a sequence of numbers, specifically "0000012". The numbers are printed in a bold, sans-serif font. The digits are evenly spaced and aligned horizontally.

{2}------------------------------------------------

# 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

በበጠበበት ገ

{3}------------------------------------------------

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 .

{4}------------------------------------------------

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)