MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL

K042717 · Medical Analysis Systems, Inc. · JJX · Nov 5, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042717
• Device Name: MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.

Device Story

MAS® Diabetes Control and Dade® Diabetes Control are liquid assayed quality control materials; used in clinical laboratories to monitor precision of Hemoglobin A1c testing procedures. Product functions as a reference standard to verify analytical performance of laboratory assays. Healthcare providers use output to validate testing accuracy and ensure reliable patient results. Device does not perform patient diagnosis; serves as a quality assurance tool for laboratory instrumentation.

Clinical Evidence

No clinical data; bench testing only. Device is an assayed quality control material used for monitoring laboratory precision.

Technological Characteristics

Liquid assayed quality control material; human whole blood matrix; contains preservatives and stabilizers. Stability: 2 years unopened at -20°C, 12 months unopened at 2-8°C, 14 days opened at 2-8°C. No specific ASTM standards referenced.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c in clinical laboratory settings.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, composed of three curved lines. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 5 2004

Ms. Mary Thorsness Compliance Specialist Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, CA 93012

Re: k042717

> Trade/Device Name: MAS® Diabetes Control Dade® Diabetes Control Liquid Assayed Diabetes Control Level 1 and 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 29, 2004 Received: October 4, 2004

Dear Ms. Thorsness:

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,

Jean M. Cooper MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Liquid Assayed Diabetes Control

Medical Analysis Systems Inc. 510(k) Notification . September 29, 2004

## INDICATIONS FOR USE FORM

510(k) Number (if known): _ K 042

MAS® Diabetes Control Device Name: Dade ® Diabetes Control Liquid Assayed Diabetes Control Level 1 and 2

Indications for Use:

Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benam
Division Sign-Off

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Office of In Vitro Diagnostla Device Evaluation and Safety

510(k) K042717

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