(113 days)
AIA-PACK cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for an in-vitro diagnostic device, the AIA-PACK® cTNI 2nd Gen Troponin I Assay. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. This type of information is typically found in the 510(k) summary or the full submission, which is not included here. The letter only confirms the FDA's decision to allow the device to be marketed.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study design based solely on the provided FDA letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 2001
Ms. Lois Nakayama Manager, Quality Assurance Tosoh Medics, Inc. 347 Oyster Point Boulevard, Suite 201 South San Francisco, CA 94080
K012820 Re: Trade/Device Name: AIA-PACK® cTNI 2ª Gen Troponin I Assay Regulation Number: 21 CFR 862.1215, 862.1150 Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System, Calibrator Regulatory Class: Class II Product Code: MMI, JIT Dated: October 31, 2001 Received: November 5, 2001
Dear Ms. Nakayama:
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/cdrb/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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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
AIA-PACK cTnl 2nd-Gen Troponin I Assay
AIA-PACK cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).
Thomas C. Dota for Jean Casper
(Division Sign-Off) Division of Clinical Laboratory Devices 110/2020 510(k) Number.
Prescription Use X
Attachment I
§ 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.