BIOCHECK FERRITIN ELISA MODEL BC-1025

K992517 · Biocheck, Inc. · DBF · Sep 24, 1999 · Immunology

Device Facts

• Record ID: K992517
• Device Name: BIOCHECK FERRITIN ELISA MODEL BC-1025
• Applicant: Biocheck, Inc.
• Product Code: DBF · Immunology
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.

Device Story

BioCheck Ferritin ELISA is an enzyme immunoassay (EIA) test kit for quantitative measurement of ferritin in human serum samples. Used in clinical laboratory settings to assist physicians in diagnosing iron metabolism disorders. The assay utilizes standard immunoassay principles to detect ferritin levels; results are interpreted by healthcare professionals to inform clinical decision-making regarding iron deficiency or overload conditions.

Technological Characteristics

Enzyme Immunoassay (EIA) test kit; quantitative measurement of ferritin in human serum.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum to aid in the diagnosis of diseases affecting iron metabolism.

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.

Submission Summary (Full Text)

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## SEP 2 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BioCheck, Inc. c/o Ms. Robin J. Hellen Hellen Professional Service 9418 Lasaine Avenue Northridge, California 91325

K992517 Re:

> Trade Name: BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025 Regulatory Class: II Product Code: DBF Dated: July 26, 1999 Received: July 28, 1999

## Dear Ms. Hellen:

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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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/cdrl/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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## Statement for Indications for Use lll.

510(k) Number (if known): K993517

Device Name: **BioCheck, Inc. Ferritin**
*Enzyme Immunoassay Test Kit*

Indications for Use:

The BioCheck Ferritin ELISA is intended for the quantitative determination
of ferritin in human serum. This assay is to be used in the diagnosis of
diseases affecting iron metabolism.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

[Signature]
(Division Sign-Off)
Division of Clinical Laboratory Devices K992517
510(k) Number

[Checkmark] Prescription Use: ***_***OR Over the Counter Use: **_**