URICHEMTRAK LIQUID ASSAYED URINE CONTROL by MEDICAL ANALYSIS SYSTEMS, INC.

MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment.

Device Description

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AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a quality control material (MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control). This document does not contain information about studies proving a device meets acceptance criteria related to its performance in diagnosing or making clinical decisions. Instead, it's about the substantial equivalence determination for a quality control product, which itself is used to monitor the performance of other diagnostic assays.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies from this document.

The document discusses:

Device Name: MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control
Regulation Number: 21 CFR 862.1660
Regulation Name: Quality control material (assayed and unassayed)
Regulatory Class: Class I
Product Code: JJW
Indications for Use: "MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment." It also mentions "For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®".

This type of device is not "tested" in the same way a diagnostic algorithm or a new medical treatment device would be. Its "performance" is based on its stability and consistency in providing known concentrations, rather than diagnostic accuracy metrics like sensitivity or specificity. While the manufacturer would have internal data to ensure the quality control material itself meets manufacturing specifications, this document does not describe such studies or acceptance criteria for a diagnostic performance context.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL I 2003

Ms. Penny M. Layman Manager, Regulatory Affairs Medical Analysis Systems, Inc, 5300 Adolfo Road Camarillo, CA 93012

Re: K031441

Trade/Device Name: MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJW Dated: May 2, 2003 Received: May 8, 2003

Dear Ms. Layman:

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).

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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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 Putman

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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INDICATIONS FOR USE FORM

Page 1 of 1

510(k) Number (if known):

MAS® UrichemTRAK, Tri-Level Device Name: Liquid Assayed Urine Control

Bayer Urine Control

Indications for Use:

Bayer Urine Control

For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

prescription use ✓

Albert Seitz

Division Sign-Off

(Optional Format 3-10-98)

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K031441

Regulation Number and Section

§ 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.