VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)

K973331 · Ortho-Clinical Diagnostics, Inc. · DBF · Oct 22, 1997 · Immunology

Device Facts

• Record ID: K973331
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DBF · Immunology
• Decision Date: Oct 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

VITROS Ferritin Reagent Pack - For the in vitro quantitative measurement of Ferritin in human serum and plasma (heparin). Measurements of Ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemachromatosis (iron overload) and iron deficiency anemia. VITROS Ferritin Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Ferritin in human serum and plasma (heparin) VITROS Ferritin Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of Ferritin

Device Story

The VITROS Immunodiagnostic Products Ferritin system consists of a reagent pack, calibrators, and controls used on the VITROS Immunodiagnostic System. It performs in vitro quantitative measurement of Ferritin in human serum and plasma (heparin). The system is intended for use in clinical laboratory settings by trained personnel. By measuring Ferritin levels, the device assists healthcare providers in diagnosing iron metabolism diseases such as iron deficiency anemia and hemochromatosis. The system provides quantitative results that inform clinical decision-making regarding iron status and patient management.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic reagent system for quantitative measurement of Ferritin. Components include reagent pack, calibrators, and controls designed for use on the VITROS Immunodiagnostic System.

Indications for Use

Indicated for the in vitro quantitative measurement of Ferritin in human serum and plasma (heparin) 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Ann M. Quinn, RAC Manager, Regulatory Affairs and Quality Ortho-Clinical Diaqnostics Regulatory Affairs 100 Indigo Creek Drive Rochester, New York 14650-0882

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 2 1997

Re : K973331 Trade Name: Vitros™ Immunodiagnostic Products Ferritin Reagent Pack (GBM.1340) Vitros™ Immunodiagnostic Products Ferritin Calibrators (GEM.C340) Vitros™ Immunodiagnostic Products Ferritin Controls (GEM.5045) Regulatory Class: II Product Code: DBF September 03, 1997 Dated: Received: September 04, 1997

Dear Ms. Quinn:

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 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 requirement, 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 Putman

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 of Intended Use (Appendix D)

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications for Use:

K973331

VITROS Immunodiagnostic Products Ferritin Reagent Pack VITROS Immunodiagnostic Products Ferritin Calibrators VITROS Immunodiagnostic Products Ferritin Controls

VITROS Ferritin Reagent Pack - For the in vitro quantitative measurement of Ferritin in human serum and plasma (heparin). Measurements of Ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemachromatosis (iron overload) and iron deficiency anemia.

VITROS Ferritin Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Ferritin in human serum and plasma (heparin)

VITROS Ferritin Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of Ferritin

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

evice Evaluation (ODE)
Lita E. Makem

(Division Sign-Off)
Division of Clinical Laboratory Devices K9 73331
510(k) Number.

Prescription Use

OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

VITROS Immunodiagnostic Products Ferritin Reagent Pack VITROS Immunodiagnostic Products Ferritin Calibrators VITROS Immunodiagnostic Products Ferritin Controls