HEMOCHEK-A1C SAMPLE COLLECTION KIT

K990899 · Osborn Group, Inc. · LCP · Dec 21, 1999 · Hematology

Device Facts

• Record ID: K990899
• Device Name: HEMOCHEK-A1C SAMPLE COLLECTION KIT
• Applicant: Osborn Group, Inc.
• Product Code: LCP · Hematology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.

Device Story

HemoChek-A1c Sample Collection Kit facilitates remote HbA1c testing. Kit includes sample card with proprietary filter paper, sterile lancet, alcohol swab, gauze, bandage, and mailing envelopes. Patient collects capillary blood sample via lancet, applies to filter paper, and mails to Osborn Group, Inc. laboratory. Laboratory performs HbA1c measurement using existing assay methods; results mailed to patient. Intended for patient/physician evaluation of long-term glucose control. Enables convenient home-based sample collection without immediate clinical supervision.

Clinical Evidence

No clinical data. Performance testing demonstrates the device performs in the same manner as the HemoChek predicate device.

Technological Characteristics

Kit includes proprietary filter paper sample card, sterile lancet, alcohol swab, gauze, and adhesive bandage. Analysis performed via existing laboratory assay methodology. No electronic components, software, or connectivity.

Indications for Use

Indicated for over-the-counter sale for patients at home or in physician offices requiring HbA1c measurement for assessment of average blood glucose over 10-12 weeks. Not indicated for diabetes mellitus diagnosis.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• EZCHEK™/HbA1c Sample Collection Kit (K971919)
• HemoChek Sample Collection Kit (K984529)

Submission Summary (Full Text)

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1990899

DEC 2 1 1999

Image /page/0/Picture/2 description: The image shows the logo for Osborn Group, INC. The logo is in black and white and features a curved line above the word "OSBORN". Below the company name is the text "A ChoicePoint Company" in a smaller font. The logo is simple and professional.

### 510(k) SUMMARY

### Osborn Group, Inc.

## HemoChek-A1c Sample Collection Kit

March 17, 1999

### Submitter Information:

Osborn Group, Inc. 19401 West 117th Street Olathe, Kansas 66062

Submitter's Name: Phone:

Gilbert P. Bourk III [phone]

#### Device Name:

HemoChek-A1c Sample Collection Kit

Common Name: Hemoglobin A1c blood sample collection kit

Classification Name: Glycosvlated Hemoglobin Assay

### Predicate Device Equivalence:

Substantial equivalence is claimed to the EZCHEK™/HbA1c Sample Collection Kit, and to the HemoChek Sample Collection Kit, cleared for commercial distribution per K971919 and K984529, respectively.

### Device Description:

The HemoChek-A1c Sample Collection Kit is a kit which is purchased by a patient a pharmacy or other retail store. The kit consists of the following:

- A Sample Card containing the proprietary filter paper that the blood sample is placed on and a place for the patient to print his/her name, address, social security number and the sample was collected
- A pamphlet containing detailed instructions about how to obtain a blood sample and mail it to Osborn -Group, Inc.
- A specimen envelope with the words "After blood has dried, insert completed HemoChek test in this envelope. Seal flap and place in envelope" printed on it
- A self-adhesive envelope in which the card is inserted and then mailed to Osborn Group, Inc. -

Image /page/0/Picture/23 description: The image shows the logo for Osborn Laboratories, a ChoicePoint company. The logo features a stylized letter "L" formed by a grid pattern within a circle. To the right of the circular element, the words "OSBORN LABORATORIES" are printed in a simple, sans-serif font, with the tagline "A ChoicePoint Company" appearing in a smaller font size below.

Image /page/0/Picture/24 description: The image shows the logo for Intellisys, an Osborn Company. The word "INTELLISYS" is written in a bold, sans-serif font, with a curved line above it. Below the word "INTELLISYS" is the phrase "AN OSBORN COMPANY" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.

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- A sterile lancet -
- An alcohol swab -
- A gauze pad -
- An adhesive bandage -
- -An outer package containing all of the items listed above

After purchasing the HemoChek-A1c Sample Collection Kit, the patient then prints the required information on the Sample Card and collects a blood sample, using a lancet (either the one provided in the kit, one provided by the patient's physician or one supplied by the patient). The blood sample is placed on both circles on the right hand side of the Sample Card, as described in the instructions. The Sample Card is then placed in the specimen envelope which in turn is placed in the mailing envelope provided in the kit and mailed to Osborn Group, Inc. When the blood sample is received by Osborn Group, Inc., the patient's HbA1c level is measured using existing assay methods. The results are then mailed to the patient.

### Intended Use:

The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.

#### Comparison of Technological Characteristics:

Essentially, the devices use the same basic technology, i.e., collecting a blood sample and analyzing it using an existing assay methodology. However, the physical size of the device is different than the EZCHEK predicate device. Also, the existing assay methodologies used are different for the device and the EZCHEK predicate device, but are the same as for the HemoChek predicate device.

### Summary of Performance Testing:

Information contained in this submission demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device.

#### Conclusions:

Based on the above, we concluded that the HemoChek-A1c Sample Collection Kit is substantially equivalent to legally marketed predicate devices and iffective for its intended use.

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 21 1999

Mr. Gilbert P. Bourk III Vice President and General Counsel Osborn Group, Inc. 14901 West 117th Street Olathe, Kansas 66062

K990899 Re:

> Trade Name: HemoChek-A1c™ Sample Collection Kit Regulatory Class: II Product Code: LCP Dated: October 29, 1999 Received: November 1, 1999

Dear Mr. Bourk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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

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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Image /page/4/Picture/0 description: The image shows the logo for Osborn Group, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the text "A ChoicePoint Company" in a smaller font. A curved line extends from the top of the "O" in Osborn to the bottom of the "N".

## Device Name:

HemoChek-A1c™ Sample Collection Kit

# Indications for Use:

The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.

Peter E. Makris

(Division Sign-Off)
Division of Clinical Laboratory Devices Ka90899
510(k) Number

ver the counter.

Image /page/4/Picture/11 description: The image shows the logo for Osborn Laboratories. The logo consists of a circular design on the left, made up of small squares, with a larger square in the center. To the right of the circular design, the text "OSBORN LABORATORIES" is displayed in a simple, sans-serif font. Below this, the text "A ChoicePoint Company" is written in a smaller font size.

Image /page/4/Picture/9 description: The image shows the logo for Intellisys, an Osborn Company. The word "INTELLISYS" is in large, bold, sans-serif font, with a line underneath. Below the line, in a smaller font, it says "AN OSBORN COMPANY". There is a curved line above and to the right of the word "INTELLISYS".