TIBC

K981654 · Abbott Laboratories · JMO · Jul 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981654
• Device Name: TIBC
• Applicant: Abbott Laboratories
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jul 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

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.

Device Story

The TIBC assay is an in vitro diagnostic clinical chemistry test for human serum. The process involves sample pretreatment where ferric chloride saturating solution is added to bind available apotransferrin sites with iron; alumina adsorbent is then used to remove excess iron. The resulting mixture is analyzed for total iron content, and the result is multiplied by a dilution factor. The assay is performed on the AEROSET Analyzer. Results are used by clinicians to assess iron binding capacity, assisting in the diagnosis and management of anemia.

Clinical Evidence

Bench testing only. Method comparison studies on the AEROSET Analyzer against the predicate (ABBOTT SPECTRUM Series II) showed a correlation coefficient of 0.9896, slope of 0.988, and Y-intercept of 6.790 ug/dL. Precision studies (within-run, between-run, between-day) reported total %CV of 2.1% (Level 1) and 4.3% (Level 2). The assay is linear up to 1778.5 ug/dL with a limit of quantitation of 3.8 ug/dL.

Technological Characteristics

In vitro clinical chemistry assay; utilizes ferric chloride saturating solution and alumina adsorbent for sample pretreatment; quantitative analysis performed on AEROSET Analyzer; linear range 11.4 ug/dL to 5335.5 ug/dL.

Indications for Use

Indicated for the quantitation of total 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

• A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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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### 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 [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 vitro 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]. 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 [phone] or at [phone] 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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