(50 days)
The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma. The test is used as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.
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The provided text is a 510(k) clearance letter from the FDA for "Spectral's Troponin I Test," an in vitro diagnostic device. This document does not contain the detailed information required to answer your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and directs the manufacturer to various FDA offices for further information on labeling, promotion, and other responsibilities.
Therefore, I cannot extract the requested information from the provided text. The document does not describe a study that proves the device meets acceptance criteria in the way you've outlined for an AI/device performance evaluation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 01 2002
Nisar A. Shaikh, Ph.D. Director Quality Systems Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario M9C 1C2 Canada
Re: K014105
Trade/Device Name: Spectral's Troponin I Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: December 11, 2001 Received: December 13, 2001
Dear Dr. Shaikh:
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 I notification. The FDA finding of substantial equivalence of your device to a legally marketed nouthoution. The I Dr 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 1 11 you dolly 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, (301) 59 r tact 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 1101) 443-6597 or at its internet address "http://www.fda.gov/odrh/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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Spectral Diagnostics Inc. Spectral's Troponin I Test 510(k) Notification
Kol4105
510(k) Number (if Known) : Not Known at this time
Device Name : Spectral's Troponin I
Indications for Use:
The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the The Speculars Troponial Problem Interdiac troponin I in human whole blood, serum, and Tapid quantanve decemiination of can ocardial infarction in emergency room, critical care, point of care and hospital settings.
Geon Cooper
(Division Sign-Off)
Division of Clinical Laborato:
510(k) Number K01405
(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)
§ 862.1215 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.