(43 days)
QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material intended to monitor the naman of clinical immunological test procedures that analyze for tumor associated antigens.
QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material.
The provided document is a 510(k) clearance letter from the FDA for the Qualitrol Tumor Marker Control, Levels 1 and 2. It states that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory document does not typically contain detailed information about the acceptance criteria and the comprehensive study results of the kind requested in the prompt.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" and provides its indications for use. It does not detail specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a control material, not an AI-assisted diagnostic device, so an MRMC study is not relevant and not discussed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as it's a control material.
- The type of ground truth used: Not available in this document.
- The sample size for the training set: Not applicable/available for this type of device and regulatory submission.
- How the ground truth for the training set was established: Not applicable/available for this type of device and regulatory submission.
Summary based on the provided document:
The document concerns the Qualitrol Tumor Marker Control, Levels 1 and 2, described as a "lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze for tumor associated antigens."
The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices. This implies that the device has met the regulatory requirements by demonstrating it performs as safely and effectively as a predicate device, but the specific performance demonstration data is not included in this letter.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 9 1999
Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. 2170 Woodward Street Austin, Texas 78744-1832
K993631 Re: Trade Name: Qualitrol Tumor Marker Control, Levels 1 and 2 Regulatory Class: I Product Code: JJY Dated: October 29, 1999 Received: October 27, 1999
Dear Mr. Sewell:
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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INDICATIONS FOR USE STATEMENT
510(k) number (if known): K 993621
Device name:
QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2
Indications for use:
QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material intended to monitor the naman of clinical immunological test procedures that analyze for tumor associated antigens.
Peter G. Maken
§ 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.