(137 days)
Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.
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The provided text is a 510(k) clearance letter from the FDA for a device called "ADI Syphilis RPR Liquid Controls." This letter grants clearance based on substantial equivalence to a predicate device, which is different from a study proving a device meets acceptance criteria.
The document does not contain any information about:
- Acceptance criteria table or reported device performance for a study.
- Sample sizes for test or training sets, data provenance, or ground truth establishment.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The document's purpose is to inform Ampcor Diagnostics, Inc. that their device is substantially equivalent to a previously marketed device and can therefore be marketed. It refers to general controls provisions of the Act and compliance with Good Manufacturing Practice requirements, but it does not detail a specific performance study or its results for the ADI Syphilis RPR Liquid Controls device itself.
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Image /page/0/Picture/10 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH & HUMAN" is visible along the left side of the image, oriented vertically. To the right of the text is the HHS symbol, which consists of three stylized human profiles.
JUL C 1698
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Raymond Miller Official Correspondent Ampcor Diagnostics, Inc. 603 Heron Drive, Bldg. 3 Bridgeport, NJ 08014
Re: K980638 Trade Name: ADI Syphilis RPR Liquid Controls Regulatory Class: II Product Code: GMP Dated: May 13, 1998
Received: May 14, 1998
Dear Mr. Miller:
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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Autman
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): 4980638
Device Name: ADI Syphilis RPR Liquid Controls
Indications For Use:
Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubac
(Division Sign Off) Division of Clinical Laboratory Devices
510(k) Number K980638
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).