(27 days)
UrichemTRAK Liguid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.
UrichemTRAK Liquid Assayed Control, Levels 1 and 2
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Urichem TRAK Liquid Assayed Control, Levels 1 and 2." This document primarily focuses on regulatory approval, intended use, and general controls.
It does not contain the detailed information required to answer your request about acceptance criteria and the specifics of a study proving the device meets those criteria. Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details on standalone (algorithm only) performance.
- The type of ground truth used (expert consensus, pathology, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states the device's "Statement of Indications for Use" as a quality control material for general chemistry assays, intended for evaluating analytical precision, reagent, and instrument performance. This type of device is a control material, not typically an AI-powered diagnostic or decision support system that would undergo the kind of detailed performance studies you're asking about in the context of AI.
Therefore, I cannot fulfill your request based on the provided input.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 9 1998
Scot D. Kinghorn Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058
Re : K981933 Urichem TRAK Liquid Assayed Control, Levels 1 and 2 Regulatory Class: I Product Code: JJW Dated: May 29, 1998 Received: June 2, 1998
Dear Mr. Kinghorn:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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 requlations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally finding or subbeanstar of results in a classification for your markets product of mits your device to proceed to the market. at you desire specific advice for your device on our labeling requlation (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 "dsmo@fdadr.cdrh.fda.gov".
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) Notification ● May 29, 1998 UrichemTRAK Liquid Assayed Control Levels 1 and 2
Statement of Indications for Use
UrichemTRAK Liguid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.
Prescription Use
Carol C. Benarsh Alfred Montgomery
ivision Sign-Off) Division of Clinica 510(k) Number
§ 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.