ABBOTT ARCHITECT FERRITIN

K983759 · Abbott Laboratories · DBF · Dec 7, 1998 · Immunology

Device Facts

• Record ID: K983759
• Device Name: ABBOTT ARCHITECT FERRITIN
• Applicant: Abbott Laboratories
• Product Code: DBF · Immunology
• Decision Date: Dec 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Device Story

The Abbott ARCHITECT Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) designed for use on the Abbott ARCHITECT i System. It processes human serum or plasma samples to quantitatively measure ferritin levels. The system utilizes microparticles and chemiluminescent detection to determine analyte concentration. It is intended for clinical laboratory use by trained personnel to assist healthcare providers in diagnosing iron metabolism conditions, specifically iron deficiency anemia and hemochromatosis. Results are used by clinicians to inform diagnostic and therapeutic decisions regarding iron status.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the ARCHITECT Ferritin assay to the AxSYM Ferritin assay using 518 clinical specimens. Results showed a correlation coefficient of 0.986, a slope of 1.18 (95% CI 1.17-1.20), and an intercept of -3.65 ng/mL (95% CI -14.53 to 7.24) via least squares linear regression. Passing-Bablok analysis yielded a correlation coefficient of 0.986, a slope of 1.17 (95% CI 1.16-1.19), and an intercept of -1.89 ng/mL (95% CI -2.64 to -1.23).

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA) technology. Analyte detection via microparticle-based binding and chemiluminescence. Compatible with human serum and plasma (lithium heparin or tripotassium EDTA). Designed for use on the automated Abbott ARCHITECT i System. Calibration performed using Abbott ARCHITECT Ferritin Calibrators; accuracy/precision verified with Abbott Ferritin Controls.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum and plasma to aid in the diagnosis of iron metabolism disorders, including hemochromatosis and iron deficiency anemia.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• AxSYM® Ferritin assay

Submission Summary (Full Text)

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### 510(k) Summarv

## Abbott ARCHITECT™ Ferritin

# Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Ferritin constitutes data supporting a substantially equivalent determination.

The ARCHITECT Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma (lithium heparin or tripotassium EDTA). The ARCHITECT Ferritin assay is calibrated with Abbott ARCHITECT Ferritin Calibrators. Abbott Ferritin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.

Substantial equivalence has been demonstrated between the ARCHITECT Ferritin assay and the AxSYM® Ferritin assay. The intended use of both assays is for the quantitative determination of ferritin in human serum and plasma. A least squares linear regression analysis between these two assays, using 518 specimens, over the range of 1 to 2000 ng/mL, yielded a correlation coefficient of 0.986, a slope of 1.18, (95% Confidence Interval [CI] of 1.17 to 1.20), and an intercept of -3.65 ng/mL (95% CI of -14.53 to 7.24). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.986, a slope of 1.17, (95% CI of 1.16 to 1.19), and an intercept of -1.89 ng/mL (95% CI of -2.64 to -1.23).

In conclusion, these data demonstrate that the ARCHITECT Ferritin assay is as safe and effective as, and is substantially equivalent to, the AxSYM Ferritin assay.

Prepared and Submitted October 23, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092

Abbott Laboratories ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064-3537

ARCHITECT Ferritin 510(k) October, 1998 er510k.do

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 7 1998

Laura L. Granitz Sr. Regulatory Specialist Dept. 9V6 Bldg. AP31 ABBOTT LABORATORIES 200 Abbott Park Road Abbott Park, IL 60064-3537

K983759 Re: Trade Name: Abbott ARCHITECT™ Ferritin Regulatory Class: II Product Code: DBF October 23, 1998 Dated: October 26, 1998 Received:

Dear Ms. Granitz:

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 legally marketed predicate 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 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 regulations 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 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 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in four of your device to a legally marketed predicate device equivalence or possification 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 regaration (br on. . please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and 594 4500. Indiations 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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): \$983751 Device Name: Abbott ARCHITECT™ Ferritin Indications For Use:

> The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

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Concurrence of CDRH/Office of Device Evaluation (QDE),

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number *K983759*

Prescription Use √
OR
Over-The-Counter Use *_*

(Per 21 CFR 801.109)

(Optional Format 1-2-96)