BIOTEST HEMOGLOBIN MEASURING SYSTEM

K020710 · Biotest Medizintechnik GmbH · GKR · Aug 14, 2002 · Hematology

Device Facts

• Record ID: K020710
• Device Name: BIOTEST HEMOGLOBIN MEASURING SYSTEM
• Applicant: Biotest Medizintechnik GmbH
• Product Code: GKR · Hematology
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5620
• Device Class: Class 2

Indications for Use

The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.

Device Story

Biotest Hemoglobin Measuring System performs quantitative hemoglobin determination in blood. Device operates as an automated hemoglobin system; intended for clinical laboratory use. Provides quantitative results to healthcare providers to assist in diagnostic decision-making regarding patient hemoglobin levels.

Technological Characteristics

Automated Hemoglobin System; classified under 21 CFR 864.5620; Product Code GKR.

Indications for Use

Indicated for the quantitative determination of hemoglobin in blood for clinical diagnostic use.

Regulatory Classification

Identification

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top and sides. Inside the circle is a stylized image of an eagle with three lines forming its body and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 4 2002

Mr. Mark Licata President Bio.Track LLC 800 East Leigh Street Richmond, Virginia 23219

Re: k020710

> Trade/Device Name: Biotest Hemoglobin Measuring System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR Dated: July 12, 2002 Received: July 12, 2002

Dear Mr. Licata:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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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Page of

20710 510(k) Number (if known):_ Device Name: BioTEST H&MOglobiN

Indications For Use:

biotrack

Bio•Track LLC 800 Leigh Street Richmond, VA 23219 804/828-9329

February 28, 2002

EXHIBIT D Statement of Intended use

The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Jorphine Boutati

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Prescription Use & (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)