DS30 HCY BLOOD COLLECTION TUBES

K012152 · Drew Scientific , Ltd. · GIM · Sep 18, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012152
• Device Name: DS30 HCY BLOOD COLLECTION TUBES
• Applicant: Drew Scientific , Ltd.
• Product Code: GIM · Clinical Chemistry
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.

Device Story

DS30 Hcy Blood Collection Tube is a plastic, evacuated tube containing EDTA and 3-deazaadenosine. Used by clinical laboratory personnel to collect and stabilize 2.5 mL whole blood samples. The enzyme inhibitor 3-deazaadenosine prevents post-collection homocysteine production in blood cells. Stabilized samples are processed to remove plasma, which is then analyzed via HPLC for total homocysteine levels. Facilitates accurate detection of hyperhomocysteinæmia by maintaining sample integrity between collection and laboratory analysis.

Clinical Evidence

No clinical data provided; device is a specimen collection accessory.

Technological Characteristics

Plastic evacuated tube; contains EDTA (anticoagulant) and 3-deazaadenosine (enzyme inhibitor); 2.5 mL capacity; designed for whole blood collection and stabilization for HPLC analysis.

Indications for Use

Indicated for the collection and stabilization of 2.5 mL whole blood samples from patients requiring total homocysteine measurement for the detection of hyperhomocysteinæmia.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2001

Dr. Andrew Kenny Research & Development Director Drew Scientific Ltd Sowerby Woods Industrial Estate Barrow-in-Furness Cumbria, LA14 4QR UK

k012152 Re:

Trade/Device Name: DS30 Hcy Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: GIM Dated: July 9, 2001 Received: July 11, 2001

Dear Dr. Kenney:

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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) 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 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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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 v 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" (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 vours,

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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Indication for use 10.0

Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.

prescription use

Kesia Alexander for Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012152