EZCHEK/HBA BLOOD COLLECTION KIT

K971919 · Flexsite Diagnostics, Inc. · LCP · Sep 5, 1997 · Hematology

Device Facts

• Record ID: K971919
• Device Name: EZCHEK/HBA BLOOD COLLECTION KIT
• Applicant: Flexsite Diagnostics, Inc.
• Product Code: LCP · Hematology
• Decision Date: Sep 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The device is intended for at-home or in-office use to collect a sample for hemoglobin A1c determination. The product will be marketed over-the-counter.

Device Story

EZCHEK™/HbA1c Sample Collection Kit facilitates remote monitoring of long-term blood glucose control. Kit includes lancet, alcohol wipe, filter paper test request form, biohazard bag, and return envelope. User performs finger-stick, applies capillary blood to filter paper, and mails sample to laboratory. Laboratory performs hemoglobin A1c analysis using an antibody-based method. Healthcare providers receive results to assess patient glycemic control over 4-8 weeks. Benefits include convenient, non-invasive sample collection for patients, enabling regular monitoring without frequent office visits.

Clinical Evidence

Bench testing confirmed stability of blood spots under transport conditions (up to 115°F, freeze-thaw cycles). Clinical evaluation at three sites confirmed ease of use by professionals. Correlation studies comparing filter paper samples to whole blood hemolysate showed high agreement: professional site correlation (n=56, r=0.978, y=0.999x+0.06) and home-use correlation (n=43, r=0.956, y=0.983x+0.37). Patient questionnaires indicated high acceptability.

Technological Characteristics

Kit for capillary blood collection on filter paper. Analytical method utilizes antibody-based assay (cleared commercial method). Filter paper treated with standard clinical laboratory chemicals. Designed for at-home or in-office use. No electronic components or software.

Indications for Use

Indicated for over-the-counter at-home or doctor's office use to obtain a finger-stick whole blood sample for laboratory monitoring of long-term (4-8 weeks) blood sugar control in patients with diabetes mellitus. Not indicated for the diagnosis of diabetes mellitus.

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

• Self-Assure®/GHb (K861697)

Submission Summary (Full Text)

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K971919

### 58 9-5-97

Image /page/0/Picture/2 description: The image shows the text "FLEXSITE DIAGNOSTICS, INC." in a bold, serif font. The word "FLEXSITE" is followed by a stylized globe-like image with horizontal lines. The text is slightly angled upwards from left to right. The overall impression is that of a professional logo or company name.

# 510(K) SUMMARY

May 21, 1997

| SUBMITTER: | FLEXSITE DIAGNOSTICS, INC.<br>3543 SW CORPORATE PARKWAY<br>PALM CITY, FL 34990 |
|-----------------|--------------------------------------------------------------------------------------|
| | PHONE: [phone]<br>FAX: [phone] |
| CONTACT PERSON: | Robert Ray<br>FLEXSITE DIAGNOSTICS, INC.<br>PHONE: [phone]<br>FAX: [phone] |
| TRADE NAME: | EZCHEK™/HbA1c Sample Collection Kit |
| COMMON NAME: | Self-monitoring glycohemoglobin (hemog |

globin Aic Self-monitoring glycohemog. COMMON NAME: capillary blood collection kit.

Glycosylated Hemoglobin Assay CLASSSIFICATION NAME: (21C.F.R. 864.7470)

Self-Assure®/GHb; K861697/A. PREDICATE DEVICE:

> The device is a kit containing the materials required to DESCRIPTION: The do no no a capillary blood sample from a finger-stick on a piece of filter paper and mail it to a laboratory for determination of its hemoglobin A16 %. The kit contains a lancet, an alcohol wipe, a test request form with filter paper, a biohazard bag, a return envelope with lifter papereturning a result to the patient and/or his/her doctor.

> > 43 245

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#### INTENDED USE: The device is intended for at-home or in-office use to collect a sample for hemoglobin A1c determination. The product will be marketed over-the-counter.

#### SUMMARY OF TECHNOLOGICAL SIMILARITIES AND DIFFERENCES:

The key components of the kit are functionally identical to SIMILARITIES: those in the Self-Assure kit.

DIFFERENCES: 1. The method of analysis of glycohemoglobin has changed from attinity chromatography to an antibody method from another commercial source. This method is FDA cleared.

- 2. The filter paper treatment has been changed to be compatible with the new antibody method. The new treatment is with a standard chemical in common use in clinical labs.
- 3. The name of the product has been changed.

NONCLINICAL PERFORMANCE DATA: The principal difference as noted in labove is the method of analysis. The new antibody based method, which as cleared uses whole blood or whole blood hemolysate samples, was shown to give accurate results when using blood spots collected on filter paper as judged from the following correlation data: y = 1.03x -0.13; r = 0.988; n = 53. The precision of measuring blood spots was 2.9% within run at 6.7% HbAt. Total precision over a 20 day study was 3.3 % at 6.7% HbAis. The stability of blood spots at temperature extremes was shown to be compatible with expected transport conditions (up to 115°F and to three freeze-thaw cycles).

CLINICAL PERFORMANCE DATA: Kits were evaluated in three sites to confirm the ease of use by medical professionals in an office setting. Results were also correlated to whole blood hemolysate tests as an additional confirmation of the validity of collection on filter paper. Correlation was Y =0.999x + 0.06; r = 0.978; n = 56. Patients given the kit to take home gathered samples and mailed them to the laboratory. These results also correlated very well (y = 0.983x +0.37; r = 0.956; n= 43) to whole blood hemolysate results. Patients filled out questionnaires regarding the ease of use etc. Their comments indicated that the kit is acceptable as designed.

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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 and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP - 5 1997

Donald R. Stone Flexsite Diagnostics, Tnc. C/O McKenna & Cuneo, L. L. P. 1900 K Street, N.W. -Washington, D.C. 20006-1108

K971919 Re : EZCHEK™/HBA Sample Collection Kit Regulatory Class: II Product Code: LCP August 15, 1997 Dated: Received: August 15, 1997

Dear Mr. Stone:

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 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 The general controls provisions of provisions of the Act. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulatory action. in addition, FDA may publish further announcements concerning Please note: this your device in the Federal Register. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHIA-66), Child device may if it does, you should contact categorization: - 16 accessions on Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your 510(k) picmailor of your device to a legally marketed predicate device results in a classification for your marketed predicate device formits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpcorrart 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at [phone]. Compriance ac (30 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 obtained from the brying [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Hutman

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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510(k) Number: K971919

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use

Prescription Use (Per 21 CFR 801.109) OR