HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801

K061047 · Hemocue AB · GKR · Jun 8, 2006 · Hematology

Device Facts

• Record ID: K061047
• Device Name: HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
• Applicant: Hemocue AB
• Product Code: GKR · Hematology
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5620
• Device Class: Class 2

Indications for Use

The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

Device Story

HemoCue Hb 301 system is a portable photometer for hemoglobin measurement. Input: ~10 uL whole blood sample collected via capillary action into a single-use polystyrene microcuvette. Operation: Microcuvette acts as both pipette and measuring chamber; inserted into analyzer. Analyzer measures absorbance at Hb/HbO2 isobestic point using two wavelengths (506 nm and 880 nm) to compensate for turbidity. Factory calibrated against international reference hemiglobincyanide (HiCN) method. Used in primary care and point-of-care settings by clinicians to obtain rapid hemoglobin results for clinical decision-making.

Clinical Evidence

Performance demonstrated through in-house, clinical laboratory, and point-of-care center studies. Results indicate the system provides hemoglobin measurements comparable to other test methods in current clinical practice and that the intended user can operate the system to obtain expected results.

Technological Characteristics

System consists of a portable photometer and single-use polystyrene microcuvettes. Sensing principle: dual-wavelength (506 nm and 880 nm) absorbance photometry to compensate for turbidity. Factory calibrated against HiCN reference method. No active ingredients in microcuvettes. Standalone device.

Indications for Use

Indicated for quantitative point-of-care whole blood hemoglobin determination in primary care settings.

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.

Predicate Devices

• HemoCue Hemoglobin 201 system (K032203)

Submission Summary (Full Text)

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K061047

JUN - 8 2006

#### 5.0 510(k) Summary

| Submitter: | HemoCue AB<br>Box 1204<br>Ängelholm, Sweden SE-262 23<br>[phone] (Telephone)<br>[phone] (FAX) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Allan White (Official Correspondent)<br>HemoCue, Inc.<br>40 Empire Drive<br>Lake Forest, CA 92630-2244<br>[phone] x110 (Telephone)<br>[phone] (FAX)<br>[e-mail] |
| Date of Preparation: | April 13, 2006 |
| Proprietary Name: | HemoCue Hb 301 system |
| Classification Name: | Automated and Semi-Automated Hematology Devices,<br>Automated hemoglobin system (21 CFR § 864.5620),<br>Product code: GKR |
| Common Name: | Hemoglobin analyzing system |
| Equivalent to: | HemoCue AB claims substantial equivalence to the current legally<br>marketed HemoCue Hemoglobin 201 system (K032203) |

# Description

The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.

#### Intended use

The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

## Technological Characteristics

The technological characteristics for HemoCue Hb 301 system are equivalent to the predicate devices. The system consists of an analyzer (photometer) together with microcuvettes. The microcuvette is made of polystyrene plastic and contains no active ingredients. The

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microcuvette serves both as a pipette and as a measuring cuvette and is for single-use only. A blood sample of approximately 10 uL is drawn into the cavity by capillary action.

The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO2 isobestic point. The analyzer measures at two wavelengths (506 and 880 nm) in order to compensate for turbidity. The HemoCue Hb 301 System is calibrated against the hemiglobincyanide (HiCN) method, the international reference method for the determination of the hemoglobin concentration in blood. The system is factory calibrated and needs no further calibration.

| Claim | Similarities |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative point-of-care hemoglobin determination in primary care<br>using a specially designed analyzer and specially designed<br>microcuvettes. The HemoCue systems are for In Vitro Diagnostic<br>use only. |
| Result | Quantitative |
| Positioning | Point of Care |
| Analyte | Hemoglobin |
| Specimen | Whole blood |
| Labeling | Equal Directions For Use |

# Similarities with predicate device

### Assessment of Performance

Studies were conducted in-house, in clinical laboratory settings and point of care centers to demonstrate the performance of the HemoCue Hb 301 system and that the intended user can easily operate the system and obtain results as expected.

#### Conclusion

The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 8 2006

Mr. Allan White Official Correspondent HemoCue, Inc. 40 Empire Drive Lake Forest, CA 92630-2244

k061047 Re:

> Trade/Device Name: HemoCue® Hb 301 System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: II Product Code: GKR Dated: April 13, 2006 Received: April 14, 2006

Dear Mr. White:

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 (OS) 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/industry/support/index.html

Sincerely yours,

loburtz Beckerh

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K061047

Device Name: HemoCue® Hb 301 system

Indications For Use:

The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safery

J(K) K061047

HemoCue® Hb 301 system