MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3

K973451 · Medical Analysis Systems, Inc. · JJW · Sep 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973451
• Device Name: MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories, The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality. MAS Liguid Urinalysis Control Level 1, Level 2, and Level 3 is used by the Clinician as a guality control sample with known qualitative and semi-quantitative values for each of the listed constituents, physical characteristics and assay methodologies. This allows the Clinician to monitor and control the quality of the laboratory urinalysis testing results.

Device Story

MAS Liquid Urinalysis Control is a human urine-based quality control material; used in clinical laboratories to monitor routine urinalysis testing performance. The product contains known qualitative and semi-quantitative values for various analytes (e.g., Protein, Glucose, Ketones, Bilirubin, Blood, Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, Creatinine) and physical characteristics (pH, Specific Gravity, Osmolality). Clinicians use these samples to verify the accuracy and precision of laboratory assay methodologies. By comparing observed results against provided assay values, the laboratory can identify potential errors in testing procedures, equipment, or reagents, ensuring reliable patient diagnostic results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human urine-based liquid control material. Formulated with specific concentrations of analytes including Protein, Glucose, Ketones, Bilirubin, Blood, Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. Provides known assay values for qualitative and semi-quantitative urinalysis methodologies. No electronic, software, or energy-based components.

Indications for Use

Indicated for use as a quality control material in clinical laboratories to monitor and verify the accuracy and precision of routine urinalysis testing for constituents including Protein, Glucose, Ketones, Bilirubin, Blood, Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine.

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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SEP 2 9 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Scot D. Kinghorn . Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058

Re : K973451 MAS Liquid Urinalysis Control Levels 1,2, and 3 Requlatory Class: I Product Code: JJW Dated: September 10, 1997 Received: September 11, 1997

Dear Mr. Kinghorn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 predicate device results in a classification 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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ical Analysis Systems, Inc.
bin Technology Park • 542 Flynn Road • Camarillo. CA 93012-8058
boge: [phone] • FAX: [phone]

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10(k) Amendment · September 18, 1997 MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3

10K Number: K973451 evice Name: MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3

## STATEMENT OF INDICATIONS FOR USE

MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories, The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality.

MAS Liguid Urinalysis Control Level 1, Level 2, and Level 3 is used by the Clinician as a guality control sample with known qualitative and semi-quantitative values for each of the listed constituents, physical characteristics and assay methodologies. This allows the Clinician to monitor and control the quality of the laboratory urinalysis testing results.

| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | K973951 |

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