FLUID SAMPLE RETRIEVAL SYSTEM

K030394 · Biomed Personal Metabolic and Nutritional Testing · JKA · Oct 27, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030394
• Device Name: FLUID SAMPLE RETRIEVAL SYSTEM
• Applicant: Biomed Personal Metabolic and Nutritional Testing
• Product Code: JKA · Clinical Chemistry
• Decision Date: Oct 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Personal Fluid Sample Retrieval System is for use for over-the-counter distribution and is a device for collection and transportation of serum for in-vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.

Device Story

Personal Fluid Sample Retrieval System facilitates consumer-led collection of serum samples for laboratory analysis. Device includes components for fluid collection and a transport pouch for shipping samples to a testing laboratory. Intended for over-the-counter use; consumer collects sample and mails it to a facility. Laboratory performs quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol, and calculated LDL cholesterol. Results are returned directly to the consumer. System enables remote access to diagnostic testing without requiring immediate physician intervention during the collection phase.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Kit includes vacuum serum separation tubes (polypropylene caps) and transport tubes. Sensing/analysis performed externally via Vitros Chemistry analyzer using FDA-cleared reagents. No internal electronic sensing or software algorithms; relies on standard clinical chemistry laboratory instrumentation.

Indications for Use

Indicated for over-the-counter use by consumers for the collection and transport of serum samples to a laboratory for the quantitative analysis of cholesterol, triglycerides, glucose, HDL cholesterol, and calculated LDL cholesterol.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 27 2003

BioMed Personal Metabolic and Nutritional Testing, Inc. c/o Ms. Susan B. Fentress Butler, Snow, O'Mara, Stevens & Cannada, PLLC Cresent Center - Suite 500 6075 Poplar Avenue Memphis, TN 38119

Re: k030394

> Trade/Device Name: Personal Fluid Sample Retrieval System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: September 9, 2003 Received: September 10, 2003

Dear Ms. Fentress:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## APPENDIX A

# 510(k) Number: K030394 Device Name: Personal Fluid Sample Retrieval System

#### Statement of Indications for Use.

The Personal Fluid Sample Retrieval System is for over-the-counter distribution and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over-the-Counter Use<br>(Optional Format 1-2-9) | V |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

Carol C. Benenati Jean Cooper, DVM
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k030394