DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
May 23, 2013
Ortho-Clinical Diagnostics, Inc.
Attention: Ms. Kristine Tkacs
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
Trade/Device Name: ORTHOVERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS)
Classification Name: Automated Bloodborne Pathogen Test Equipment
Regulatory Class: Class II
Product Code: MZA
Dated: April 15, 2013
Received: April 25, 2013
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 (the 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: CBER 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 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.
Hira L. Nakhasi, PhD
Division of Emerging and
Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications for Use
510(k) Number: BK130006
Device Name: ORTHO VERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS)
Indications for Use:
The ORTHO® Summit System (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 OrthoâAssay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing. Only assays licensed for use on the OSS may be used with this system.
The ORTHO VERSEIA® Integrated Processor (VIP) is an automated pipetting and processing system comprised of an ORTHO VERSEIA® Pipetter (Verseia) and an ORTHO® Summit Processor (OSP) joined together to enable integrated end-to-end pipetting and processing. The ORTHO VERSEIA® Integrated Processor is to be used with licensed blood screening tests distributed by Ortho-Clinical Diagnostics, Inc. for in vitro diagnostic use.