WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180

K932661 · Whatman Specialty Products, Inc. · PJC · Apr 17, 1996 · Clinical Chemistry

Device Facts

• Record ID: K932661
• Device Name: WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
• Applicant: Whatman Specialty Products, Inc.
• Product Code: PJC · Clinical Chemistry
• Decision Date: Apr 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Device Story

Whatman BFC 180 is a body fluid collection paper designed for the collection of blood specimens. It functions as a collection medium for diagnostic testing. The device is intended for use by healthcare professionals in clinical or laboratory settings to facilitate the transport and storage of blood samples for subsequent analysis. By providing a standardized substrate for specimen collection, it assists in the diagnostic process, potentially improving the efficiency of sample handling and laboratory workflows.

Clinical Evidence

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

Technological Characteristics

Cellulose-based collection paper; form factor is a specialized paper substrate for fluid absorption; non-electronic; no software; no energy source.

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
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Whatman International Ltd.
Ms. Judith Duddy
Marketing Executive
Springfield Mill
James Whatman Way
Maidstone
Kent ME14 2LE
England

FEB 06 2015

Re: K932661
Trade/Device Name: Whatman Body Fluid Collection Paper: Whatman BFC 180
Regulation Number: 21 CFR 862.1675
Regulation Name: Blood specimen collection device
Regulatory Class: Class II
Product Code: PJC
Dated: April 4, 1996
Received: April 8, 1996

Dear Ms. Duddy:

This letter corrects our substantially equivalent letter of April 17, 1996.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 – Ms. Judith Duddy

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]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


for: Courtney H. Lias, Ph.D.
DIRECTOR
Division of Chemistry and Toxicology Devices
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health

Enclosure