Substantially Equivalent 510(k) Device Information
September 3 , 2008
Rubin & Poor, Inc.
Attn: Mr. Jonathan Poor
155 Maplewood Avenue #5
Maplewood , NJ 07040
| Re: | BK080028 |
| Product: | Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A |
| Date Received: | 19-JUN-08 |
| Classification: | II |
| Device Code: | MMH |
Dear Mr. Poor:
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.
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 advice on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028. Also, please note the regulation entitled, ² Misbranding by reference to premarket notification ² (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 ( 800) 835-4709 or (301) 827-1800 or at its Internet address: http://www.fda.gov/cber/smlbus.htm .
Sincerely yours,
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
Indications for Use
510(k) Number: BK080028
Device Name: Pool Results Manager Version 1.0C
Module for Roche NAT Testing Version 2.0A
Indications For Use:
Pool Results Manager (PRM) is intended to be used by personnel trained in its operation. The software combines data from testing and pooling sources to assign testing outcomes to blood unit IDs. Information from PRM is used to eliminate plasma units from the plasma production process.
PRM receives pooling data that defines the constituent units of pools, and collates this data with imported test result data to arrive at testing conclusions for individual unit IDs. These conclusions are then available for lookup and reporting within PRM, as well as export via creation of output files in various formats.