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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

BK130070 Letter

November 27, 2013

Bio-Rad Medical Diagnostics GmbH
Attention: Mr Scott Dennis
Bio-Rad Laboratories Inc.
6565 185th Avenue NE
Redmond, WA  98052

Re:
Device Name:
Regulation Name:
Regulatory Class:
Product Code:
Dated:
Received:
BK130070
MLB 2 (10 x 10 mL)
Potentiating Media for in vitro Diagnostic Use
II
KSG
October 25, 2013
November 6, 2013

Dear Mr. Dennis:

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 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.

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); 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 Part 801), please contact 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.  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,

/s/

For
Richard J. Davey, MD Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure
Indications for Use


Indications for Use

510(k) Number: BK130070
Device Name: MLB 2 (10 x 10 mL)

Indications for Use:

Traditional immunohematology testing is performed in the tube technique using the hemagglutination test principle. Reagents required to perform this testing include ABO, Rh (D), Rh Pheno, Kell Blood Grouping Reagents, rare antisera for typing other blood group antigens, Reagent Red Blood Cells for reverse typing and antibody screening and - identification, Anti-Human Globulin reagents, enhancement solutions and control reagents.

Element of the Special 510(k) submission:

Product name Intended Use
MLB 2, 10 x 10 mL MLB 2, 10 x 10 mL, is used for the tube test as potentiator for red blood cells applied in the indirect antiglobulin test (IAT) for crossmatch, antibody screening and - identification, as well as antigen typing with coombsreactive Blood Grouping Reagents.