TIBC

K981279 · Abbott Laboratories · JMO · May 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981279
• Device Name: TIBC
• Applicant: Abbott Laboratories
• Product Code: JMO · Clinical Chemistry
• Decision Date: May 20, 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

TIBC assay is an in vitro diagnostic clinical chemistry reagent system for serum sample pretreatment. Process involves mixing ferric chloride saturating solution with serum to bind apotransferrin sites; using alumina adsorbent to remove excess iron; and analyzing the resulting mixture for total iron content. Final TIBC value is calculated by multiplying the measured iron concentration by a dilution factor. Used in clinical laboratory settings by trained personnel. Output provides quantitative TIBC values to assist clinicians in diagnosing and managing anemia.

Clinical Evidence

Bench testing only. Comparative performance studies on the ALCYON Analyzer showed correlation with the predicate (r=0.9863, slope=0.878, intercept=36.71 ug/dL). Precision studies reported total %CV of 4.0% (Level 1) and 4.9% (Level 2). Assay is linear up to 1,400 ug/dL with a limit of quantitation of 10 ug/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Reagents include ferric chloride saturating solution and alumina adsorbent. Quantitative analysis performed via spectrophotometric iron assay. Linearity range 30-4,200 ug/dL. Standalone assay for use on clinical chemistry analyzers.

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

• Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer (K872494)

Submission Summary (Full Text)

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K 98/279

MAY 20 1998

# 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | April 7, 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: K981279

#### 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 is used in the pretreatment of serum samples for total iron binding capacity analysis with the Iron assay. 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 serum mixture. The mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution of the serum by the saturating solution.

TIBC 510(k) Anril 7, 1998 TIBC:Ell wo

Section II Page 1

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#### Substantial Equivalence:

The TIBC assay is substantially equivalent to the Boehringer Mannheim® TIBC assay on the Hitachi® 717 Analyzer (K872494).

Both assays vield 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. .

Difference:

- There is a minor difference between 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 ALCYON™ Analyzer. The TIBC assay method comparison vielded acceptable correlation with the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9863, slope = 0.878, and Y-intercept = 36.71 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 4.0% and 4.9% for Level 2/Panel 112. The Iron assay is linear up to 1,400 ug/dL. The limit of quantitation (sensitivity) for the Iron assay is 10 ug/dL. The calculated TIBC values are acceptable from 30 ug/dL to 4,200 ug/dL. These data demonstrate that the performance of the TIBC assay is substantially equivalent to the performance of the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer.

TIBC 510(k) April 7, 1998 TIBC fel lwo

Section II Page 2

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### Conclusion:

The TIBC assay is substantially equivalent to the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

TIBC 510(k)
April 7, 1998
TIBCELlwp

Section II Page 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 20 1998

Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981279 Re : TIBC Requlatory Class: I Product Code: JMO Dated: April 7, 1998 Received: April 8, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ಕ್ಷ 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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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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 [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 [phone] or 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

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K981279 510(k) Number (if known): __

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. Laboratories 79
Z

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Concurrenee of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)