SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

K012221 · Biosafe Laboratories, Inc. · JKA · Apr 3, 2002 · Clinical Chemistry

Device Facts

• Record ID: K012221
• Device Name: SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
• Applicant: Biosafe Laboratories, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is intended for over-the-counter distribution, for the self-collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.

Device Story

Kit enables at-home capillary blood self-collection via lancet; blood spotted onto filter paper card. Patient mails dried sample to certified clinical laboratory. Laboratory processes sample using modified analytical methods to measure lipid profile. Output provided to patient/provider to inform clinical decision-making regarding cholesterol management. Benefits include convenient, remote access to diagnostic lipid testing without immediate professional phlebotomy.

Clinical Evidence

Clinical trials conducted at three sites comparing self-collected capillary blood (dried on card) to professionally collected venous and capillary samples. Results demonstrated substantial equivalence to venous serum lipid profiles. Evaluated precision, total error, correlation, and sample stability under abusive storage/transport conditions.

Technological Characteristics

Kit includes filter paper blood collection card, lancet, alcohol prep, gauze, bandage, and return mailer. Uses capillary blood collection principle. Laboratory analysis utilizes standard enzymatic reagent systems. No electronic components or software algorithms integral to the collection device itself.

Indications for Use

Indicated for over-the-counter self-collection and transport of dried capillary blood for quantitative lipid profile testing (Total Cholesterol, HDL, Triglycerides, calculated LDL). Contraindicated for use on neonates. LDL calculation not applicable if triglycerides > 400 mg/dL.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Beckman Synchron Synchron CX Systems Cholesterol (CHOL) Reagent (K974046)
• Sigma EZ HDLTM Cholesterol Reagent (K972041)
• Beckman Triglycerides Reagent Kit (K781939)

Reference Devices

• Synermed Cholesterol Reagent Kit (K903015)
• Sigma Diagnostics Infinity Triglyceride Reagents (K844032)
• Sigma Diagnostics EZ-HDL Cholesterol Reagents (K972041)

Submission Summary (Full Text)

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# APR 0 3 2002

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| 1) Submitter's Name<br>Address, contact | BIOSAFE Laboratories, Inc.<br>100 Field Drive, Suite 240<br>Lake Forest, IL 60045<br>Phone: [phone]<br>FAX: [phone] | |
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| | Contact Person: | Jack A. Maggiore, PhD<br>BIOSAFE Laboratories, Inc.<br>[phone], x253 |
| | Date Prepared: | September 6, 2001 |
| 2) Device Name | Proprietary Name: | SAFE AT HOME CHOLESTEROL PROFILE<br>Blood Collection and Transport System |
| | Common Name: | At-home capillary blood self-collection and<br>transportation system for Total Cholesterol,<br>HDL-Cholesterol, Triglycerides and Calculated<br>LDL-Cholesterol |
| | | Classification Names: Cholesterol (21 CFR 862.1175)<br>HDL-Cholesterol (21 CFR 862.1475)<br>Triglycerides (21 CFR 862.1705)<br>LDL-Cholesterol (21 CFR 862.1475) |
| 3) Predicate Devices | Total Cholesterol | Beckman Synchron Synchron CX Systems<br>Cholesterol (CHOL) Reagent (K974046) |
| | HDL Cholesterol | Sigma EZ HDLTM Cholesterol Reagent<br>(K972041) |
| | Triglycerides | Beckman Triglycerides Reagent Kit (K781939) |
| 4) Device Description | The device is a kit containing the materials necessary to self-collect a<br>capillary blood sample onto a filter paper card for transport to a<br>certified clinical laboratory for lipid profile testing. The kit is<br>comprised of a blood collection card packaged in a foil pouch, alcohol<br>prep pad, disposable lancets, gauze pad, bandage strip, collection<br>instructions, return prepaid envelope, and a patient test authorization<br>form. | |
| 5) Intended Use | The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection<br>and Transport System is intended for over-the-counter distribution,<br>for the self-collection and transportation of dried capillary blood for<br><i>in vitro</i> diagnostic quantitative determination of Total Cholesterol,<br>HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in<br>dried blood spots. This kit is not intended for use on neonates. LDL<br>cannot be determined where the triglyceride value is greater than 400<br>mg/dL.<br>Continued on next page | |

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## 510(k) Summary, continued

- The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection 6) Comparison to and Transport System has technological characteristics that are predicate device substantially equivalent to that of the predicate devices listed above. The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System provides components that permit collection, storage, and transportation of a dried capillary blood sample to a certified clinical laboratory for analysis using FDA-Approved laboratory reagent and analysis systems. All predicate and current kits are intended for the in vitro diagnostic laboratory determination of lipid profile analytes. The laboratory analyses used in conjunction with (accessories of) the SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System, utilize the Synermed Cholesterol Reagent Kit (K903015), Sigma Diagnostics Infinity Triglyceride Reagents (K844032), and Sigma Diagnostics EZ-HDL Cholesterol Reagents (K972041). Results of clinical trials show that self-collected capillary samples onto the BIOSAFE Blood Collection Card provide results that are substantially equivalent to venous (serum) results for Total Cholesterol, HDL-Cholesterol and Triglycerides when analyzed using BIOSAFE Laboratories modified analytical methods.
Determination of self-collected capillary blood Total Cholesterol, 7) Performance Studies HDL Cholesterol and Triglycerides using the SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is substantially equivalent to venous (serum) samples for lipid profile testing BIOSAFE Laboratories modified analytical methods. Performance studies were conducted on self-collected capillary blood samples from volunteer study subjects at three different geographical sites. A corresponding venous blood sample and a professionally collected capillary blood sample were collected by the health care professional in order to compare serum lipid results to those obtained from both capillary blood samples collected onto the BIOSAFE Blood Collection Card. Venous samples were express shipped, and dried capillary samples were mailed directly to BIOSAFE Laboratories for lipid profile analysis by their respective methods.

8) Test Summary

Performance characteristics studied included precision, total error and In addition, the SAFE AT HOME CHOLESTEROL correlation. PROFILE Blood Collection and Transport System was evaluated for sample stability when exposed to abusive storage and transportation conditions.

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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jack Maggiore, Ph.D. Director, Clinical Trials BIOSAFE Laboratories, Inc. 100 Field Drive - Suite 240 Lake Forest, IL 60045

APR 0 3 2002

k012221 Re:

> Trade/Device Name: Safe At Home Cholesterol Profile Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: March 6, 2002 Received: March 7, 2002

Dear Dr. Maggiore:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nourication. The 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 1 11 you active open 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, ( Jor Jos at the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Steven Butman

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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# C. Indications for Use Statement

The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is intended for over-the-counter distribution, for the self-collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.

Alberto Sinti for kaiser Azi.

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_L_O 12 ここ

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