SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

K991850 · Biosafe Laboratories, Inc. · LCP · Nov 26, 1999 · Hematology

Device Facts

• Record ID: K991850
• Device Name: SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
• Applicant: Biosafe Laboratories, Inc.
• Product Code: LCP · Hematology
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Safe at-Home Test Kit for Hemoglobin A1c is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.

Device Story

Kit facilitates capillary blood collection for hemoglobin A1c testing; includes filter paper card, desiccant, alcohol prep pad, lancets, bandage, shipping materials. User collects capillary blood on filter paper; mails sample to laboratory for analysis. Intended for home or office use by patients or clinicians. Laboratory performs quantitative determination of hemoglobin A1c from dried blood spots. Results provided to healthcare provider to assist in monitoring long-term glucose control in diabetic patients.

Clinical Evidence

Performance studies conducted at three sites comparing capillary blood samples collected by lay users and healthcare professionals against venous blood samples. Results demonstrated good correlation between dried blood spot samples and whole blood samples. Study participants reported the kit was easy to use.

Technological Characteristics

Kit for capillary blood collection on filter paper. Includes lancets, alcohol prep pad, bandage, desiccant, and shipping materials. Quantitative analysis performed at laboratory. No electronic or software components.

Indications for Use

Indicated for monitoring long-term glucose control in individuals with diabetes. 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

• EZCHEK/HBA Blood Collection Kit (K971919)

Submission Summary (Full Text)

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K991850

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## 510(k) Summary

| 1) Submitter's Name<br>Address, contact | BioSafe Diagnostic Corporation<br>300 Knightsbridge Parkway, Suite 320<br>Lincolnshire, IL<br><br>Phone: [phone]<br>FAX: [phone]<br><br>Contact Person: Steven Tyrrell<br>BioSafe Laboratories<br>[phone], x222<br><br>Date Prepared: May 28, 1999 | | |
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| 2) Device Name | Proprietary Name: | Safe At Home Test Kit for<br>Monitoring Hemoglobin A1c | |
| | Common Name: | Self-monitoring Glycohemoglobin<br>Blood Collection Kit | |
| | Classification Name: | Glycosylated Hemoglobin Assay<br>(21 CFR 864.7470) | |
| 3) Predicate Device | EZCHEK/HBA Blood Collection Kit by Flexsite<br>Diagnostics (#K971919), currently marketed by Becton<br>Dickinson as the BD A1c At Home TestTM | | |
| 4) Device<br>Description | The device is a kit containing the materials necessary to<br>collect a whole blood sample on a filter paper card and<br>return the card by mail to the laboratory for determination<br>of hemoglobin A1c. The kit comprises of a filter paper<br>card in a resealable shipping bag containing a desiccant<br>pouch, alcohol prep pad, disposable lancets, bandage strip<br>instruction booklet, a return envelope, and a patient test<br>authorization form. | | |
| 5) Intended Use | The Safe At Home Test Kit for Monitoring Hemoglobin<br>A1c is intended for home-use or office-use for collection<br>and qualitative determination of hemoglobin A1c in dried<br>whole blood. The product will be marketed over-the-<br>counter. | | |

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## 510(k) Summary, continued

| 6) Comparison to<br>predicate device | The Safe At Home Test Kit for Monitoring Hemoglobin<br>Alc has essentially the same intended use, technological<br>characteristics and components as the predicate device.<br>The components are the same except that the Flexsite<br>Diagnostic's predicate device (BD Alc At Home Test TM)<br>does not include an alcohol preparation pad for pre-<br>cleaning the patient's finger or a bandage strip. The kits<br>differ also in that the blood collection spot paper in the<br>Flexsite device is attached to the Test Request Form<br>whereas these two components are separate in the BioSafe<br>device. The use of this kit affects only the sample<br>collection stage of the testing procedure. |
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| 7) Performance Studies | Performance studies were conducted on blood samples<br>collected by both a trained health care professional and the<br>lay user at three different geographical sites. A<br>corresponding venous blood sample was collected by the<br>health care professional in order to compare whole blood<br>sample results to those obtained from dried blood samples<br>collected on the Safe At Home Kit for Monitoring<br>Hemoglobin Alc. Patients were instructed to self-collect<br>their own capillary blood samples within 24 hours after<br>leaving the collection site. All samples collected were<br>mailed directly back to BioSafe Laboratories for<br>determination of percent hemoglobin Alc.<br><br>Performance characteristics studied included precision and<br>correlation. In addition, the Safe at Home Test Kit for<br>Monitoring Hemoglobin Alc was evaluated for reagent<br>and sample stability when exposed to abusive conditions.<br>Study participants were requested to complete and return<br>questionnaires regarding the kit's ease of use. |
| 9) Test Summary | The evaluation studies provided evidence that results<br>obtained using blood samples from untrained lay users<br>correlate well with whole blood samples and capillary<br>blood samples collected by trained health care<br>professionals.<br><br>Study subjects indicated that the kit is acceptable as<br>designed. |

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 26 1999

Mr. Steven P. Tyrrell Vice President, Director Research and Development BioSafe Diagnostics Corporation 300 Knightsbridge Parkway Suite 320 Lincolnshire, Illinois 60069

K991850 Re:

Trade Name: Safe At Home Test Kit for Monitoring Hemoglobin Alc Regulatory Class: II Product Code: LCP Dated: September 2, 1999 Received: September 7, 1999

Dear Mr. Tyrrell:

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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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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 (if known): | K99185D |
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Device Name: _________________________________________________________________________________________________________________________________________________________________

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## C. Indications for Use Statement

The Safe at-Home Test Kit for Hemoglobin A1c is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
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| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K991850 |

| Prescription Use (Per 21 CFR 801.109) | ✓ |
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OR

Over-The-Counter Use (Optional Format 1-2-96)