MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL

K030942 · Medical Analysis Systems, Inc. · JJY · Apr 28, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030942
• Device Name: MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The MAS® chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK H 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 us a means of assuring consistent performance of reagent and instrument. The DADE® Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trol H 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. The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. 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 chemTRAK H, DADE Moni-Trol H, and OLYMPUS Chemistry Control are liquid assayed chemistry controls; used as consistent test samples of known concentration. Operated by clinical laboratory personnel; included with patient serum specimens during routine clinical chemistry assays. Output consists of observed values compared against expected ranges; enables verification of reagent and instrument performance. Benefits include ensuring accuracy and reliability of clinical laboratory test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid assayed chemistry control; intended for use with clinical chemistry analyzers. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a quality control material in clinical laboratories to monitor assay performance and consistency of reagents and instruments when testing patient serum specimens.

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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APR 2 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k030942

Trade/Device Name: MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: March 24, 2003 Received: March 26, 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 net 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 Putman

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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Page _ 1 of _l _

510(k) Number (if known): Ko30942

Device Name:

MAS® chemTRAK® · H Liquid Assayed Chemistry Control

DADE® Moni-Trol® · H Liquid Assayed Chemistry Control

OLYMPUS Chemistry Control Liquid Assayed Chemistry Control

Indications for Use:

The MAS® chemTRAKE.• H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II 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 us a means of assuring consistent performance of reagent and instrument.

The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H 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.

The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. 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.

coopes

(Division Sign-Off)
Division of Clinical Laboratory Levice.
510(k) Number K030947

510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)

| (ODE) | Concurrence of CDRH, Office of Device Evaluation |
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Prescription Use 1 Use

OR

Over-The-Counter

(Per 21 CFR 801.109) 1-2-96)

(Optional Format