(83 days)
The Acid Hemoglobin system is intended as a qualitative screening method for the presence of abnormal hemoglobins such as HbS, HbC or HbF using agar electrophoresis.
The system will provide two kits for use on the REP, REP 3 and the SPIFE electrophoresis analyzers.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Acid Hemoglobin Kit." This document does not contain any information about the acceptance criteria, device performance, sample sizes, expert qualifications, or study details that you have requested.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given text.
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SEP 2 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Pat Franks Assistant Director Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752
Re: K992199 Trade Name: Acid Hemoglobin Kit
Regulatory Class: II Product Code: JBD Dated: June 24, 1999 Received: June 30, 1999
Dear Mr. 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 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 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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510 (k) Number (if known) :
Acid Hemoglobin Kit Device Name:
Indications for Use:
The Acid Hemoglobin system is intended as a qualitative screening method for the presence of abnormal hemoglobins such as HbS, HbC or HbF using agar electrophoresis.
The system will provide two kits for use on the REP, REP 3 and the SPIFE electrophoresis analyzers.
Peter E. Makris
(Division Sign-Off) (Division Sign-Om)
Division of Clinical Laboratory Device 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
リ
Over-The-Counter Use
(Optional Format 1-2-96)
§ 864.7440 Electrophoretic hemoglobin analysis system.
(a)
Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.(b)
Classification. Class II (performance standards).