BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

K011970 · Biosafe Laboratories, Inc. · CHH · Sep 26, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011970
• Device Name: BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
• Applicant: Biosafe Laboratories, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Sep 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for 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 collects capillary blood via lancet onto filter paper card; sample dried for transport to certified clinical laboratory. Laboratory performs quantitative lipid profile analysis using modified analytical methods. Used in clinical settings by healthcare professionals. Output provides lipid levels to clinicians for diagnostic decision-making. Benefits include simplified sample collection and transport for lipid monitoring.

Clinical Evidence

Performance studies conducted at three sites comparing professionally collected capillary blood (dried) to venous serum samples. Evaluated precision, linearity, and correlation. Results demonstrated substantial equivalence to venous serum lipid profile results.

Technological Characteristics

Kit includes blood collection card, lancets, alcohol prep pad, gauze, bandage, and instructions. Uses filter paper for dried blood spot collection. Analysis performed at clinical laboratory using modified analytical methods. No electronic or software components.

Indications for Use

Indicated for prescription-based, clinic-use collection and transport of dried capillary blood for quantitative lipid profile testing (Total Cholesterol, HDL, Triglycerides, calculated LDL). Not indicated for neonates. Contraindicated for LDL calculation when triglycerides exceed 400 mg/dL.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

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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| | | 510(k) Summary | K011970 |
|------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) | Submitter's Name<br>Address, contact | BIOSAFE Laboratories, Inc.<br>100 Field Drive, Suite 240<br>Lake Forest, IL 60045 | |
| | | Phone: [phone]<br>FAX: [phone] | |
| | | Contact Person: | Jack A. Maggiore, PhD<br>BIOSAFE Laboratories, Inc.<br>[phone], x253 |
| | | Date Prepared: | August 22, 2001 |
| | 2) Device Name | Proprietary Name: | BIOSAFE CHOLESTEROL PROFILE<br>Blood Collection and Transport System |
| | | Common Name: | 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 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 BIOSAFE CHOLESTEROL PROFILE Blood Collection and<br>Transport System is intended for prescription distribution, and is a<br>clinic-use device for collection and transportation of dried capillary<br>blood for <i>in vitro</i> diagnostic quantitative determination of Total<br>Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-<br>Cholesterol in dried blood spots. This kit is not intended for use on | |
| Continued on next page | | neonates. LDL cannot be determined where the triglyceride value is<br>greater than 400 mg/dL | |

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- The BIOSAFE CHOLESTEROL PROFILE Blood Collection and 6) Comparison to Transport System has technological characteristics and an intended predicate device use that are substantially equivalent to that of the predicate devices listed above. The BIOSAFE 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-Cleared 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 the BIOSAFE 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 Results of clinical trials show that Reagents (K972041). professionally 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 professionally collected capillary blood Total 7) Performance Studies Cholesterol, HDL Cholesterol and Triglycerides using the BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is substantially equivalent to venous (serum) samples for lipid profile BIOSAFE Laboratories modified analytical methods. testing Performance studies were conducted on professionally collected blood samples from volunteer study subjects at three different geographical sites. A corresponding venous blood sample was collected by the health care professional in order to compare serum lipid results to those obtained from 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.

Performance characteristics studied included precision, linearity and correlation. In addition, the BIOSAFE CHOLESTEROL PROFILE 8) Test Summary 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

SEP 2 6 2001

k011970 Re:

Trade/Device Name: BIOSAFE Cholesterol Profile Blood Collectionand Transport System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Regulatory Class: Class I, reserved Product Code: CHH, LBS, CDT Dated: August 23, 2001 Received: September 4, 2001

Dear Dr. Maggiore:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfed in the encreations of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, atere, mains of the Act include requirements for annual registration, listing of general voltared pro resuring 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 If your device is classified (600 wor ols. Existing major regulations affecting your device can may be subject to back as a saccrations, 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 i loast be advisou that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must or uny I cacal batales and strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607); adoning (21 CFR Part 820); and if applicable, the electronic forul in the quality by seaths (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 I Dri Imaling of succion 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 CFF Part 801 and 1 IT you desire specific daily of the diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in The clagitestions on the promotion and advertising of your device, [phone]. Runnenally, spiliance 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 Information on your responsibilities and er Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/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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K011970

C - 1

## C. Indications for Use Statement

The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for Dystem is mended for pion of dried capillary blood for in vitro diagnostic concetion and "thisportation" of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on Caromates. LDL Cholosteror in aired where the triglyceride value is greater than 400 mg/dL.

\checkmark prescription use

Kesia Alexander for Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number.