(238 days)
- A. To provide calibration of local prothrombin time systems to accord with the WHO prothrombin time (PT) standardisation scheme ("the existing device").
- B. To avoid the need for local availability of an international reference preparation (IRP) for thromboplastin. IRP are not normally available except to national control laboratories and manufacturers. . .
- C. To avoid the need for the performance of the manual PT- technique required for conventional WHO calibrations. Most centres have now discarded the manual technique for automated procedures and are no longer skilled in the manual PT technique.
- D. To avoid the requirement for fresh plasma donations from 60 patients stabilised on warfarin treatment required for the conventional WHO calibrations.
- E. To facilitate serial calibration studies to check against drift of automated instruments or the effect of batch changes of commercial thromboplastin reagent.
- F. To provide a rapid result. A PT system calibration with the Calibrants takes about half an hour whereas a conventional WHO calibration requires several days. Five days are recommended by the revised 1999 WHO protocol.
Not Found
This document is a 510(k) clearance letter from the FDA for "Poller Calibrants," a device used for prothrombin time systems standardization. The letter itself does not contain detailed information about the acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text is regulatory correspondence granting marketing clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and the study details based solely on the provided text. The document refers to the "indications for use stated in the enclosure," which is not fully included, and does not provide specifics on performance studies or validation data.
To answer your request, I would need access to the actual 510(k) submission (K991439) for the "Poller Calibrants," which would typically contain the detailed study plan, acceptance criteria, results, and other technical documentation.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
DEC 2 0 1999
Professor L. Poller European Concerted Action on Anticoagulation Department of Pathological Sciences Stopford Building The University of Manchester Oxford Road Manchester M13 9PT. UK
Re: K991439 Trade Name: Poller Calibrants Regulatory Class: II Product Code: GGN Dated: October 21, 1999 Received: November 1, 1999
Dear Professor Poller:
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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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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| 510(k) Number (if known): | K991439 |
|---|---|
| Device Name: | "Poller Calibrants" |
Indications For Use:
INDICATIONS FOR USE
- A. To provide calibration of local prothrombin time systems to accord with the WHO prothrombin time (PT) standardisation scheme ("the existing device").
- B. To avoid the need for local availability of an international reference preparation (IRP) for thromboplastin. IRP are not normally available except to national control laboratories and manufacturers. . .
- C. To avoid the need for the performance of the manual PT- technique required for conventional WHO calibrations. Most centres have now discarded the manual technique for automated procedures and are no longer skilled in the manual PT technique.
- D. To avoid the requirement for fresh plasma donations from 60 patients stabilised on warfarin treatment required for the conventional WHO calibrations.
- E. To facilitate serial calibration studies to check against drift of automated instruments or the effect of batch changes of commercial thromboplastin reagent.
- F. To provide a rapid result. A PT system calibration with the Calibrants takes about half an hour whereas a conventional WHO calibration requires several days. Five days are recommended by the revised 1999 WHO protocol.
(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 De 610(k) Number l Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.