MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL

K031392 · Medical Analysis Systems, Inc. · DKC · Jul 1, 2003 · Clinical Toxicology

Device Facts

• Record ID: K031392
• Device Name: MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
• Applicant: Medical Analysis Systems, Inc.
• Product Code: DKC · Clinical Toxicology
• Decision Date: Jul 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended 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.

Device Story

MAS® Tox - Ammonia Control is a liquid assayed toxicology control used in clinical laboratories. It serves as a quality control material to monitor the precision and accuracy of chemistry systems when assaying human serum or plasma for alcohol, ammonia, acetaminophen, and salicylate. The control is processed alongside patient specimens; the healthcare provider compares the observed assay values against provided expected ranges. This comparison allows the laboratory to verify the consistent performance of reagents and instruments, ensuring reliable clinical test results for patient diagnosis and management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid assayed toxicology control; aqueous-based matrix; contains alcohol, ammonia, acetaminophen, and salicylate; intended for in vitro diagnostic use; compatible with clinical chemistry systems.

Indications for Use

Indicated for use in clinical laboratories as a quantitative control to monitor the precision and accuracy of test procedures for alcohol, ammonia, acetaminophen, and salicylate in human serum or plasma specimens.

Regulatory Classification

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.

Predicate Devices

• Bayer ToxAmmonia Control

Submission Summary (Full Text)

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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: 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 [phone]. 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 [phone] or [phone] 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:

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.

## Bayer ToxAmmonia

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

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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)