(13 days)
LiniCAL™ Immunology Calibration Verifiers Levels A – E for Beckman Coulter Synchron CX® Systems are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron CX® Systems. Five assayed levels are provided for IgA, IgG, IgM, TRF, ASO and PAB to allow monitoring of the reportable range.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called LiniCAL™ Immunology Calibration Verifiers. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test sets or their data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
The document primarily focuses on the regulatory clearance for marketing the device and its intended use as calibration verifiers. It does not delve into the performance evaluation data typically found in a scientific or technical study report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 1 2003
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432 South Mission Road Fallbrook, California 92028
Re: K030074
Trade/Device Name: LiniCAL™ Immunology Calibration Verifiers Levels A - E for Beckman Coulter Synchron CX® Systems
Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX Dated: January 7, 2003 Received: January 8, 2003
Dear Ms. Ruggiero:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K030074
Device Name: LiniCAL™ Immunology Calibration Verifiers Levels A -- E for Beckman Coulter Synchron CX® Systems
Indications For Use:
LiniCAL™ Immunology Calibration Verifiers Levels A – E for Beckman Coulter Synchron CX® Systems are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron CX® Systems. Five assayed levels are provided for IgA, IgG, IgM, TRF, ASO and PAB to allow monitoring of the reportable range.
(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)
Over-the-counter Use
D. Flores for J. Bautista
n Sian-Division of Clinical Laboratory Devices
KO30074 510(k) Number-
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.