(136 days)
The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of CRP level in human serum to aid in the evaluation of the amount of injury to body tissues. (for Professional use only)
The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA).
This is a letter from the FDA regarding the 510(k) premarket notification for the UBI MAGIWEL™ C-Reactive Protein (CRP) Quantitative AD-401 device. The document states that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.
However, the provided text does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, data provenance, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or the specific type of ground truth used.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 9 1998
Chin Shu Chenq, Ph.D. Director United Biotech, Inc. 110 Pioneer Way #C Mountain View, California 94041-1517
Re : K973692/S1 UBI MAGIWEL™ C-Reactive Protein (CRP) QUANTITNTIVE Trade Name: AD-401 Regulatory Class: II Product Code: DCK Dated: December 10, 1997 Received: December 15, 1997
Dear Dr. Cheng:
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, Druq, 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, listinq of devices, qood manufacturing practice, labelinq, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 Reqister. 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-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 regulation (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.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
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K973699 510(k) Number (if known):
Device Name: c-reactive Protein EIA
Indications for Use:
The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of CRP level in human serum to aid in the evaluation of the amount of injury to body tissues. (for Professional use only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
Prescription Use ✓
(Per 21 CFR 801.109)
CF
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).