(69 days)
The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, metastatic carcinoma and as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in particular after a meal. Intestinal Isoenzymes occur in blood type O or B after a meal.
Not Found
This document is a 510(k) clearance letter from the FDA for the SPIFE 2000/3000 ALP device. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.
The letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, not on a new study providing specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter confirming regulatory clearance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, emphasizing its official and governmental nature.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Pat Franks Assistant Director/Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752
MAY 0 6 2002
Re: K020625
Trade/Device Name: SPIFE 2000/3000 ALP Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CIN Dated: March 25, 2002 Received: April 5, 2002
Dear Ms. Franks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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):
020625
SPIFE 2000/3000 ALP
Device Name:
Indications for Use:
The test system will be used in laboratories to separate serum ALP The test system will be used in raborations of macrones.
. Elevated bone isoenzyme can be found in conditions of physiologic bone in Elevated bone isoenzyme can be found in concerner and as rickets.
Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver.
Inteatinal isoenzymes can be seen in patients with intestinal disease in
ter and the beach blocktore of or R after a meal . Intestinal Isoenzymed our Bood type O or B after a meal.
Glen Coogin
Division Sign
Division of:
510(k) Number: K020625
(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
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.