(8 days)
QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.
QUICKCHECK Lyophilized Chemistry Control Also Distributed as: CONFORMANCE® Chemistry Control C3
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested in your prompt. The document is an FDA 510(k) clearance letter for a device called "QUICKCHECK Lyophilized Chemistry Control" (also distributed as "CONFORMANCE® Chemistry Control C3").
This letter primarily states that the device is substantially equivalent to a predicate device and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance with manufacturing practices. It also includes an "Indication for Use" section.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test or training sets.
- Details on data provenance or ground truth establishment.
- The number or qualifications of experts used.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) studies or standalone performance.
The document is a regulatory approval, not a scientific study report or a detailed performance and validation document. Therefore, I cannot extract the specific information you are looking for from this text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three intertwined strands instead of snakes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 21 1996
E. Kay Robinson · Business Unit Manager-Proficiency Products Consolidated Technoloqies, Inc. 2170 Woodward Street, Suite 100 Austin, Texas 78744-1832
K981339 Re : QUICKCHECK Lyophilized Chemistry Control CONFORMANCE®® Chemistry Control C3 Requlatory Class: I Product Code: JJY Dated: April 9, 1998 Received: April 13, 1998
Dear Ms. Robinson:
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 aqainst 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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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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Indication for Use
QUICKCHECK Lyophilized Chemistry Control Device Name: Also Distributed as:
CONFORMANCE® Chemistry Control C3
Control and/or Lyophilized Chemistry Indication for Use: QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981339
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.