(52 days)
The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for the "SPIFE CK Kit". It states that the device is substantially equivalent to a legally marketed predicate device for the identification and quantitation of serum creatine kinase isoenzymes, particularly useful in detecting acute myocardial infarction. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts, adjudication methods, or ground truth establishment for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
- Information about a standalone algorithm performance study.
- Details on the type of ground truth used.
- Sample size for a training set or how its ground truth was established.
This document is a regulatory approval, not a scientific study report.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Patricia Franks Assistant Director of Regulatory Affairs Helena Laboratories, Inc. 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752
OCT 1 1 2002
K022757 Re:
Trade/Device Name: SPIFE CK Kit Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHY Dated: August 15, 2002 Received: August 20, 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 (OS) 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/cdrb/dsmaldsmamain.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): ΚΟΣΣ 757
Device Name: SPIFE CK Kit
Indications for Use:
The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.
Cooges
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KA22757
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
And Children Children
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
and the state of the state of the subject of
OR
Over-The-Counter Use
(Optional Format 1-2-96)
the state of the state of the state of the state of the states and the second
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.