MAS LIPID LEVEL 1 AND 2

K030679 · Medical Analysis Systems, Inc. · JJY · Mar 14, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030679
• Device Name: MAS LIPID LEVEL 1 AND 2
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The MAS® Lipid control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include MAS® Lipid control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the 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® Lipid control functions as an assayed quality control material for clinical laboratory lipid testing. It is a liquid or lyophilized sample of known concentration used alongside patient serum specimens. Laboratory personnel process the control through the same analytical systems used for patient samples. By comparing the resulting measurements against provided expected ranges, clinicians verify the consistency and accuracy of reagent and instrument performance. This monitoring process helps ensure the reliability of lipid assay results, supporting accurate clinical decision-making for patient lipid management.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Assayed quality control material for lipid determinations. Formulated as a consistent test sample for use in clinical laboratory instrumentation. Operates as a reference standard for monitoring reagent and instrument performance.

Indications for Use

Indicated for use in clinical laboratories as a quality control material to monitor the performance of lipid determination assays by comparing observed values against expected ranges.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 4 2003

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

Re: k030679

> Trade/Device Name: MAS® Lipid Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: March 3, 2003 Received: March 4, 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 [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 Butman

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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## SECTION 5

K 030679

## INTENDED USE AND INDICATIONS FOR USE OF THE DEVICE

The MAS® Lipid control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include MAS® Lipid control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

x Prescription Use

CaufC. Bonam B. Jean Cooper, Dil.

Division Sign-Off Division of Clinical Laboratory Devic 510(k) Number