CLINICAL LABORATORY ANALYZING SYSTEM

K041230 · Hemocue, Inc. · LFR · May 20, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041230
• Device Name: CLINICAL LABORATORY ANALYZING SYSTEM
• Applicant: Hemocue, Inc.
• Product Code: LFR · Clinical Chemistry
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. The use of any other device in the HemoCue Glucose 201DM Analyzer except the HemoCue Glucose 201 Microcuvettes is neither supported not recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Glucose 201 Microcuvettes are for in vitro use only.

Device Story

System consists of HemoCue Glucose 201DM Analyzer and HemoCue Glucose 201 Microcuvettes; performs quantitative determination of glucose in whole blood. Input: whole blood sample in microcuvette. Operation: photometric analysis of blood glucose concentration; includes plasma conversion. Output: instant blood glucose concentration displayed to user. Used in clinical settings for diabetes management and neonatal monitoring. Healthcare providers use output to supplement clinical evidence for diagnosis and treatment decisions. Benefits: rapid, point-of-care glucose monitoring.

Clinical Evidence

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

Technological Characteristics

Modification adds data management system functionality. Fundamental scientific technology unchanged. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative determination of glucose in whole blood for diagnosis and treatment of patients with diabetes and monitoring of neonatal blood glucose levels.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three horizontal lines that curve and taper towards the right, resembling a human figure in motion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 0 2004

HemoCue, Inc. c/o Mr. R. J. Slomoff Consultant to HemoCue, Inc. 9229 Cranford Drive Potomac, MD 20854

k041230 Rc:

Trade/Device Name: HemoCue® Glucose 201 DM System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test sytem Regulatory Class: Class II Product Code: LFR Dated: May 6, 2004 Received: May 10, 2004

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 gencral 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 practicc requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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.

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,

Sean M. Cooper, US, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K041230 510(k) Number (if known):

HemoCue® Glucose 201 DM System Device Name:

Indications For Use:

Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

Thereagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. The use of any other device in the HemoCue Glucose 201DM Analyzer except the HemoCue Glucose 201 Microcuvettes is neither supported not recommended by HemoCue, and could give erroneous results with serious clinical consequences.

The HemoCue Glucose 201 Microcuvettes are for in vitro use only.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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)

Keun Cooper

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 041230

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