MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL

K023307 · Medical Analysis Systems, Inc. · JJX · Oct 31, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023307
• Device Name: MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

MAS Diabetes Control is intended for use in the clinical laboratory as an assayed control material suitable for monitoring assay conditions for glycated hemoglobin determinations. Include with patient specimens when assaying for glycated hemoglobin. 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 Diabetes Control is a lyophilized assayed chemistry control material (Level 1 Normal and Level 2 Abnormal) used in clinical laboratories. It serves as a quality control tool for monitoring glycated hemoglobin assay performance. Laboratory personnel include the control with patient specimens during testing. By comparing observed assay values against provided expected ranges, clinicians verify the consistency and accuracy of reagents and analytical instruments. The device helps ensure reliable diagnostic results for patient monitoring.

Clinical Evidence

No clinical data provided; device is a quality control material evaluated via bench-top assay performance verification.

Technological Characteristics

Lyophilized assayed chemistry control material. Provided in two levels: Level 1 (Normal) and Level 2 (Abnormal). Designed for use with specific clinical laboratory systems for glycated hemoglobin analysis.

Indications for Use

Indicated for use in clinical laboratories as an assayed control material to monitor assay performance for glycated hemoglobin determinations. Used alongside patient specimens to verify reagent and instrument consistency.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 31 2002

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

k023307 Re: Trade/Device Name: MAS® Diabetes Control Regulation Number: 21 CFR 862,1660 Regulation Name: Quality control material (assayed and unassaved) Regulatory Class: Class I Product Code: JJX Dated: October 2, 2002 Received: October 3, 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 mav 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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): K023307

Device Name:

MAS® Diabetes Control Lyophilized Assayed Chemistry Control Level 1 (Normal) and 2 (Abnormal)

Indications for Use:

MAS Diabetes Control is intended for use in the clinical laboratory as an assayed control material suitable for monitoring assay conditions for glycated hemoglobin determinations. Include with patient specimens when assaying for glycated hemoglobin. 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.

San Coope

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices 233 510(k) Number.

_ prescription use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)