MAS AND MINI-TROL PTH CONTROL

{0}------------------------------------------------ #### 510K SUMMARY DEC = 3 ""09 109274 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92 The assigned 510(k) number is: TBD ## COMPANY/CONTACT PERSON Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific, Specialty Diagnostics Division, CDx Fremont 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 office (510) 979-5422 fax ## DATE PREPARED August 30, 2009 #### DEVICE NAME #### Trade Names: MAS® PTH Control Moni-Trol® PTH Control # Common Names: Liquid Assayed PTH Control #### Device Classification: Class I Classification Panel: Quality Control Material (Assayed and Unassayed) for Clinical Chemistry Regulation number: 21 CFR 862.1660 Product Code: JJX #### INTENDED USE: MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. {1}------------------------------------------------ Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. ## SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE MAS® PTH Control Moni-Trol® PTH Control is substantially equivalent to the previously cleared Liquichek ™ Specialty Immunoassay Control (K043108) ## DESCRIPTION OF DEVICE This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or bodily fluids. Preservatives and stabilizers are added to maintain product integrity. | Comparison | Predicate Device, K043108 | Proposed new device | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For use as quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. | MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.<br><br>Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. | | | Include PTH Control with patient serum<br>specimens when assaying for<br>Parathyroid hormones. Assay values<br>are provided for the specific systems<br>listed. The user can compare<br>observations with expected ranges as<br>means of assuring consistent<br>performance of reagent and instrument. | | | Description<br>of device | This product is<br>prepared from human<br>serum with added<br>constituents,<br>chemicals, stabilizers,<br>and preservatives. | This product is a liquid stable control<br>material prepared from human serum.<br>Analyte levels are adjusted with various<br>pure chemicals and preparations from<br>human tissue or bodily fluids.<br>Preservatives and stabilizers are added<br>to maintain product integrity. | | Matrix | Human Serum | Human Serum | | Form | Liquid | Liquid | | Storage<br>Condition | -20°C to -70°C until<br>expiration date on the<br>label | -25°C to -15°C until expiration date on<br>the label | | Open Vial<br>Stability | 30 days at 2-8°C with<br>exceptions | 30 days when stored tightly capped at<br>2-8°C | | Closed Vial<br>Stability | 30 days at 2-8°C with<br>exceptions | 90 days when stored tightly capped at<br>2-8°C | | Analytes | Anti-Tg<br>Anti-TPO<br>C-Peptide<br>Erythroprotein<br>Intact PTH<br>IGF-I<br>Osteocalcin<br>25 OH Vitamin D | PTH | #### Comparison of Technological Characteristics {2}------------------------------------------------ -- -- -- : and the comments of the comments of {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002 > DEC 3 2009 Microgenics Corporation c/o Ms. Lisa Charter Manager, Regulatory affairs Thermo Fisher Scientific Specialty Diagnostics Division, CDx Fremont 4630 Fremont Blvd. Fremont, CA 94538 Re: k092749 Trade/Device Name: MAS® PTH Control and Moni-Trol® PTH Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 04, 2009 Received: September 08, 2009 Dear Ms. Charter: 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 (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 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); {4}------------------------------------------------ Page 2 - Ms. Lisa Charter labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Sincerely vours, ia m chan Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indication for Use 510(k) Number (if known): K092749 Device Name: MAS® PTH Control Moni-Trol® PTH Control Indication For Use: MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. Prescription Use x (21 CFR Part 801 Subpart D) Subpart C) And/Or Over the Counter Use (21 CFR Part 801 (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Maria M. Chan Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K092749