(276 days)
The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.
Not Found
I cannot fulfill this request. The provided text is a regulatory document from the FDA regarding a medical device, the "Trinity Biotech's Rotavirus EIA". It is a clearance letter for a 510(k) submission and discusses substantial equivalence, regulatory classifications, and general controls.
The document does not contain any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria (beyond stating that the device is substantially equivalent to a predicate).
- Sample sizes for test sets or training sets.
- Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an abstract symbol, possibly representing a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Trinity Biotech, Inc. c/o Ms. Grace Holland Holland & Associates 3722 Avenue Sausalilo Irvine, California 92606
AUG - 8 1997
Re: K964424/S2 -------------------------------------------------------------------------------------------------------------------------------------------------------------------Trade Name: Trinity Biotech's Rotavirus EIA Regulatory Class: I Product Code: LIQ Dated: January 31, 1997 Received: February 3, 1997
Dear Ms. Holland:
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 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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 - Trinity Biotech K964424 - - - - -
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:Trinity_Biotech's_Rotavirus_EIA
Indications For Use:
The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants.
The performance characteristic was not determined in the elderly population.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | ________________________________ |
Prescription Use________________ OR Over-The-Counter Use________________
(Pcr 21 CFR 801.109)
(Optional Format 1-2-96)
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§ 866.3405 Poliovirus serological reagents.
(a)
Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.