MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL

K021155 · Medical Analysis Systems, Inc. · JJW · Apr 29, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021155
• Device Name: MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Apr 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

MAS® / DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. 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 equipment. The product is suitable for use as a control material for physiochemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.

Device Story

MAS™ UA Control and DADE® UA Control are liquid assayed quality control materials used in clinical laboratories. They serve as reference samples with known expected ranges for routine urinalysis procedures, including physiochemical and microscopic methods. Laboratory personnel use these controls to verify the consistent performance of urinalysis reagents and equipment. By comparing observed results against provided assay values, clinicians ensure the accuracy and reliability of patient test results. The device does not perform analysis itself but acts as a standard to validate the operational status of urinalysis systems.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material; performance is established through assay value assignment and verification of consistency with urinalysis reagent systems.

Technological Characteristics

Liquid assayed control material for urinalysis. Formulated for qualitative and semi-quantitative physiochemical and microscopic urinalysis methods. Provides expected assay ranges for standardized urinalysis systems.

Indications for Use

Indicated for use in clinical laboratories as a quality control material for qualitative and semi-quantitative routine urinalysis testing, including physiochemical and microscopic methods.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

APR 2 9 2002

Re: k021155

Trade/Device Name: MAS™ UA Control Levels 1, and 2 and DADE® UA Control Levels 1 and 2

Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJW Dated: April 9, 2002

Received: April 10, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nothication. The I D71 incing of successification 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 II you desire specific advice for your as to coses contact the Office of Compliance at additionally 609.10 for in This chaglestions on the promotion and advertising of your device, [phone]. Addinonary, 10. quest at [phone]. Also, please note the regulation prease conact the Orneo or Computation (21CFR 807.97). Other general entitled, "Misoranding by reference to per the Act may be obtained from the Division of Small
information on your responsibilities under the Act may 1001 - 1001 - 1607 Information on your responsionnes analy under [phone] or [phone] or at its ivianaractarers - 15ttp://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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 FORM

510(k) Number (if known): _ KO2 1155 The MAS® UA Control Device Name: Liquid Assayed Urinalysis Control

> DADE® UA Control Liquid Assayed Urinalysis Control

Indications for Use:

MAS® / DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. 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 equipment. The product is suitable for use as a control material for physiochemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| 510(k) Number | K021155 |

(Optional Format 3-10-98)

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