(131 days)
mis kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis. mese tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.
SPIFETM Electrophoresis System
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested. The document is an FDA 510(k) clearance letter for the SPIFE™ Electrophoresis System, which indicates that the device has been found substantially equivalent to a predicate device.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Information about experts, ground truth establishment, or adjudication methods.
- Details on multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot fulfill your request based on the provided input.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 27 1997
Pat Franks . Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752
Re : K972274 SPIFE™ Electrophoresis System & SPE VIS-60 Procedure Requlatory Class: I Product Code: CEF Dated: June 12, 1997 Received: June 18, 1997
Dear Ms. Franks:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖ 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 In addition, FDA may publish further announcements action. 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 requlations.
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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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
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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Page 1 of 1
510(k) Number (if known): Unknown at this time
Device Name:
SPIFETM Electrophoresis System
Indications for Use:
mis kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis.
mese tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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(Optional Format 1-2-96)
§ 862.1630 Protein (fractionation) test system.
(a)
Identification. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.