HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

K053253 · Hemocue AB · KQO · Feb 17, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053253
• Device Name: HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
• Applicant: Hemocue AB
• Product Code: KQO · Clinical Chemistry
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed system, the HemoCue Albumin 201 analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.

Device Story

System performs quantitative turbidimetric immunoassay for albumin in human urine. User collects urine sample into specialized microcuvette containing reagents; microcuvette inserted into HemoCue Albumin 201 analyzer. Device uses capillary force to draw sample; performs automated mixing and immunochemical reaction. Analyzer measures turbidity via optical detection; calculates albumin concentration proportional to turbidity. Results displayed on screen within 90 seconds. Used in point-of-care and clinical laboratory settings by healthcare professionals. Provides rapid quantitative data to assist clinicians in screening, diagnosing, and monitoring microalbuminuria, facilitating timely clinical decision-making.

Clinical Evidence

Studies conducted in-house and in clinical settings to demonstrate system performance and ease of use by intended professional users. No specific sensitivity, specificity, or AUC metrics provided in the summary document.

Technological Characteristics

Turbidimetric immunoassay. Polystyrene microcuvettes with dried rabbit anti-human albumin antibody, PEG, Tris/HCL-buffer, and polymers. Photometric measurement at 610 nm. Factory calibrated. Portable analyzer with cuvette holder, vibration mechanism, and optronic unit. Electrical safety per IEC 60601-1; EMC per EN 55011/EN 61000 series.

Indications for Use

Indicated for quantitative, rapid, turbidimetric immunoassay of albumin in human urine for screening, diagnosis, and monitoring of microalbuminuria in professional clinical settings. Suitable for spot samples or timed collections.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

• Clinitek 50 Urine Chemistry Analyzer

Submission Summary (Full Text)

{0}------------------------------------------------

053 253

| Submitter: | HemoCue AB<br>Box 1204<br>Angelholm, Sweden SE-262 23 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | [phone] (Telephone)<br>[phone] (FAX) |
| Contact: | 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: | November 18, 2005 |
| Proprietary Name: | HemoCue Albumin 201 analyzing system |
| Classification Name: | Automated Urinalysis System |
| Common Name: | HemoCue Albumin 201 |
| Equivalent to: | Clinitek 50 Urine Chemistry Analyzer |
| Microcuvette: | Regulation Number = 862.1645<br>Product Code = JIQ<br>Classification = Class I exempt |

#### 510(k) Summary 10.0

#### Description

Discription The Hemoouvettes. The microcuvette contains reagents deposited on its inner walls. The plastic microcavettes. The merces on one of the filled cuvette is inserted into urine sample is that in the the contents of the cuvette are mixed through the HomoCae Fribunan 2005, the immunochemical reaction is completed and the turbidity is vioration. Within 90 comment concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.

### Intended Use

The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a The qualifiative, fupic, the HemoCue Albumin 201 analyzer. The system can be used specially decigitive determination of low levels of albumin in urine for the purpose of for the qualifically o osing, monitoring and to supplement the clinical evidence in the servening for, and grounds, aria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine

{1}------------------------------------------------

Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.

# Technological Characteristics

The HemoCue Albumin 201 assay employs an immunoassay for the microalbumin test. The The HemoCuc Alountin 201 about only the sample is drawn into the microcuvette by reagents are continued in the microcuvettes are inserted into the analyzer for measuring. Capillary force anter which the reaction steps and automatically performs The remocule Albumn 201 Thanyses Results are displayed on the instrument screen. The system is factory calibrated.

## Assessment of Performance

Studies were conducted in-house and in clinical settings to demonstrate the performance of Studies were conducted in noube and that the intended user can easily operate the system and obtain urinalysis results as the predicate device.

#### Conclusion

The HemoCue Albumin 201 analyzing system is a convenient method for measuring The HelloCue > Abumin 201 and Jused by typical users and provide clinical results microunding in arme and ears of in current clinical laboratory and point-of-care practices.

{2}------------------------------------------------

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 its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

FEB 1 7 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HemoCue AB c/o Mr. Allan White HemoCue, Inc. 40 Empire Drive Lake Forest, CA 92630-2244

Re: k053253

Trade/Device Name: HemoCue Albumin 201 Analyzer Regulation Number: 21 CFR 862.2900 Regulation Name: Automated Urinalysis System Regulatory Class: Class I Product Code: KQO, JIQ Dated: January 25, 2006 Received: January 26, 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 (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your le FDA finding of substantial equivalence of your device to a legally premarket notification. "The PDs 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, rr you don't opportive mostion and advertising of your device, please contact the Office of In of questions on the promostic Device Evaluation and Safety at [phone]. Also, please note the vitro Diagnetitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may of amall 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 vours,

Alberto Gutz

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): KOS 3253

Device Name: __ HemoCue Albumin 201 analyzer

Indications For Use:

The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially The qualifilative, rapid, turblaiment inimanousedy of the system is designed be used for the designed system, the Homoodo Albemin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the or screening for, diagnosing montoning on testing using spot samples or timed treathern of microutburnmand. The Stained within 90 seconds. HemoCue Urine Albumin Collections: A quanticative roodic is obtained in the HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes.

Prescription Use
(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)

Carol Benson

Page 1 of 1

K053253