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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120006 Letter

March 15, 2012

Ortho-Clinical Diagnostics, Inc.
Attention: Ms. Kristine Tkacs
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606

Re:
Trade/Device Name:

Classification Name:
Regulatory Class:
Product Code:
Dated:
Received:
BK120006
ORTHO VERSEIA® Pipetter as Part of the ORTHO® Summit System (OSS) v 3.0
Automated Bloodborne Pathogen Test Equipment
Class II
MZA
March 7, 2012
March 8, 2012

Dear Ms. Tkacs:

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 has been 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

/signature/

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and
Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure


Indications for Use

510(k) Number: BK120006

Device Name: ORTHO VERSEIA Pipetter® as Part of the Ortho Summit® System (OSS) v 3.0

Indications for Use:

The ORTHO® Summit (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.

The ORTHO VERSEIA™ Pipetter is intended to be used for the pipetting of enzyme-linked immunosorbent assays (ELISA), including licensed blood screening tests distributed by Ortho-Clinical Diagnostics, Inc. The instrument aspirates and dispenses samples and reagents into microplates. The ORTHO VERSEIA™ Pipetter reads identification (ID) barcodes on the sample tubes, controls/calibrators, reagent containers, and microplates. For in vitro diagnostic use.