(68 days)
semiquantitative enzyme linked immunoassay for detecting IgM at class autoantibody to for glycoprotein I (Ag GPT) for use as an aid certain autoimmune disease thrombotic diagnosis of " the in in the "diagnobis" of "cercain" addemmic lupus erythematosus (SLE) or other lupus-like disorders.
Not Found
I am sorry. I cannot provide information on the acceptance criteria and study as the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain details about specific acceptance criteria or a study proving the device meets them. It primarily states that the device is substantially equivalent to a predicate device and can be marketed.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys Myers Regulatory Affairs INOVA Diagnostics, Inc. 10451 Roselle Street San Diego, California 92121
OCT 20 1997
Re : K973014 QUANTA Lite™ B2 GPI IgM ELISA Trade Name: Requlatory Class: II Product Code: MSV Dated: August 11, 1997 Auqust 13, 1997 Received:
Dear Mr. Myers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
{1}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page of
510(k) Number (if known): < 97 3014
QUANTA Lite™ ß2GPI IgM Device Name:
Indications For Use:
semiquantitative enzyme linked immunoassay for detecting IgM at class autoantibody to for glycoprotein I (Ag GPT) for use as an aid certain autoimmune disease thrombotic diagnosis of " the in in the "diagnobis" of "cercain" addemmic lupus erythematosus (SLE) or other lupus-like disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Titus E. Mace
(Division Sign-Off) Division of Clinical Laboratory D 510(k) Number
Image /page/2/Picture/9 description: The image shows the words "Prescription Use" with a line underneath the word "Use". There is a check mark above the line. Underneath the words "Prescription Use" is the text "(Per 21 CFR 801.109)".
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).