TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3

K993546 · Medical Analysis Systems, Inc. · JJY · Nov 30, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993546
• Device Name: TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is a human serum based quality control material intended for use as a consistent test sample of known concentration for monitoring assay conditions in immunological determinations. The user can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

Device Story

Tri-Point™ BRAND Liquimmune® is a human serum-based quality control material. It serves as a consistent test sample with known concentrations for immunological assays. Used in clinical laboratories to monitor assay conditions; evaluate analytical precision; and assess reagent and instrument performance over time. The device provides a stable reference point for laboratory professionals to ensure the accuracy and reliability of immunoassay testing procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human serum-based liquid control material. Formulated for use in immunological assays to monitor analytical precision and instrument performance.

Indications for Use

Indicated for use as a quality control material for monitoring assay conditions in immunological determinations 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

## NOV 30 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K993546

> Trade Name: Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control Regulatory Class: I Product Code: JJY Dated: October 15, 1999 Received: October 19, 1999

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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 regulations.

{1}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLA 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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

{2}------------------------------------------------

Page of

.510(k) Number (if known): \$9935 40

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is a human serum based quality control material intended for use as a consistent test sample of known concentration for monitoring assay conditions in immunological determinations. The user can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Matera

1993546

Image /page/2/Picture/9 description: The image shows the words "Prescription Use" in bold font, with a check mark above the word "Use". Below that, the text "(Per 21 CFR 801.109)" is shown. This text likely indicates that the prescription use is in accordance with the Code of Federal Regulations.

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)