HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704

K032203 · Hemocue, Inc. · GKR · Aug 25, 2003 · Hematology

Device Facts

• Record ID: K032203
• Device Name: HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
• Applicant: Hemocue, Inc.
• Product Code: GKR · Hematology
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5620
• Device Class: Class 2

Indications for Use

Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201* analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.

Device Story

HemoCue Hb 201+ System is an analytical system for quantitative hemoglobin determination. Input: capillary, venous, or arterial whole blood sample collected in HemoCue Hb 201 Microcuvettes. Operation: microcuvette contains reagents; analyzer performs photometric measurement of blood sample. Output: quantitative hemoglobin concentration displayed to user. Used in clinical settings for rapid hemoglobin assessment. Provides immediate results to healthcare providers to support clinical decision-making regarding anemia or blood loss management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Analytical system consisting of a dedicated photometer (HemoCue Hb 201+ analyzer) and disposable reagent-impregnated microcuvettes (HemoCue Hb 201 Microcuvettes). Photometric measurement principle. Standalone device.

Indications for Use

Indicated for quantitative determination of hemoglobin in capillary, venous, and arterial whole blood for in vitro 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 contains a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, creating a sense of depth and movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HemoCue, Incorporated c/o R.J. Slomoff 9229 Cranford Drive Potomac, Maryland 20854

AUG 2 5 2003

k032203 Re:

> Trade/Device Name: HemoCue® Hb 201+ System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR Dated: July 14, 2003 Received: July 31, 2003

Dear Mr. Slomoff:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K032203 510(k) Number:

Device Name: HemoCue® Hb 201+ System

Indications For Use:

Quantitative determination of hemoglobin in capillary, venous and arterial whole blood.

The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes.

The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201* analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences.

The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Jauphin Bautista

Division Sigh-Off

(Optional Format 3-10-98)

**Office of In Vitro Diagnostic Device Evaluation and Safety**

510(k) K032203