MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control." This type of device is a control material used in clinical laboratories to monitor the performance of diagnostic tests.

The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically found in the 510(k) submission itself or a summary of its contents, not in the FDA's clearance letter. The clearance letter only states that the FDA has reviewed the submission and found the device to be "substantially equivalent" to a legally marketed predicate device. This means the FDA believes the new device is as safe and effective as a similar device already on the market.

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications. The letter primarily focuses on regulatory approval.

Here's what I can extract from the provided text, and why the other information is missing:

Device Name: MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control
Predicate Device Mentioned: Bayer ToxAmmonia Control (in the Indications for Use form)
Regulation Number: 21 CFR 862.3280 (Clinical toxicology control material)
Regulatory Class: Class I
Product Code: DKC
Indications for Use: "MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."
Predicate Device Indications for Use (from the form): "For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®"

Why the specific questions cannot be answered from this document:

Table of acceptance criteria and reported device performance: This letter does not contain performance data or acceptance criteria for the new device. It only refers to a "substantial equivalence" determination based on information provided in the 510(k) submission.
Sample sizes, data provenance: The document doesn't detail any specific study data or sample sizes used to demonstrate performance.
Number of experts, qualifications: Not applicable for this type of regulatory letter; this relates to the specific studies performed, not the FDA's decision letter.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable, as this is a control material, not typically an AI-assisted diagnostic device. Its performance is about its stability and accurate concentration, not reader interpretation.
Standalone performance: While the device has "standalone performance" in the sense that it performs as a control, the document does not describe a study proving this performance.
Type of ground truth used: Not applicable in the context you're asking (e.g., expert consensus for images). For a control material, the "ground truth" would be the assayed values of the analytes within the control, which are established through analytical methods by the manufacturer.
Sample size for training set: Not applicable, as this is a control material, not an algorithm trained on data.
How ground truth for training set was established: Not applicable.

To obtain the detailed information you are seeking regarding a device's performance, acceptance criteria, and study methodology, you would need to access the actual 510(k) submission summary (often available on the FDA's website) or the manufacturer's technical documentation for the device.

Summary

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines above them.

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: K031392

Trade/Device Name: MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DKC Dated: May 1, 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. Iisting 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 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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INDICATIONS FOR USE FORM

Page 1 of 1

510(k) Number (if known):

MAS® Tox · Ammonia Control Device Name: Liquid Assayed Toxicology Control

Bayer ToxAmmonia Control

Indications for Use:

Bayer ToxAmmonia

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)

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031392
(Optiona

(Optional Format 3-10-98)

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.