(58 days)
The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.
BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, etc.), or expert involvement. The document is a 510(k) clearance letter from the FDA for a medical device called "BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit," approving its marketing. It primarily focuses on the regulatory aspects and indications for use, without detailing the performance study methodology or results.
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SEP 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
BioCheck, Inc. c/o Ms. Robin J. Hellen Hellen Professional Service 9418 Lasaine Avenue Northridge, California 91325
K992517 Re:
Trade Name: BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025 Regulatory Class: II Product Code: DBF Dated: July 26, 1999 Received: July 28, 1999
Dear Ms. Hellen:
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 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). 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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.
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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/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
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Statement for Indications for Use lll.
510(k) Number (if known): K993517
Device Name: BioCheck, Inc. Ferritin
Enzyme Immunoassay Test Kit
Indications for Use:
The BioCheck Ferritin ELISA is intended for the quantitative determination
of ferritin in human serum. This assay is to be used in the diagnosis of
diseases affecting iron metabolism.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
[Signature]
(Division Sign-Off)
Division of Clinical Laboratory Devices K992517
510(k) Number
[Checkmark] Prescription Use: _OR Over the Counter Use: _
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).