RANDOX ASSAYED SPECIFIC PROTEIN CONTROL

K972608 · Randox Laboratories, Ltd. · JJY · Aug 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972608
• Device Name: RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations. The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Randox Assayed Specific Protein Control is a lyophilized human serum-based control material. Used in clinical chemistry laboratories to monitor the accuracy and precision of specific protein analysis assays. Available in two constituent concentrations (Low and Elevated). Operated by qualified laboratory personnel. Functions as a reference material to verify assay performance; results are compared against established target values to ensure clinical chemistry instrumentation and reagents are performing within acceptable parameters.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum-based control material. Provided in two concentrations (Low and Elevated). Designed for use in clinical chemistry specific protein analysis.

Indications for Use

Indicated for use as a quality control material for monitoring accuracy and precision in clinical chemistry specific protein analysis. Intended for use by qualified laboratory personnel in a clinical laboratory setting.

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/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. P. Armstrong Regulatory Affairs RANDOX LABORATORIES LTD. Ardmore, Diamond Road Crumlin, BT29 4QY Co. Antrim, N. IRELAND

AUG - 4 1997

Re: K972608 Trade Name: RANDOX Assayed Specific Protein Control Regulatory Class: II Product Code: JJY Dated: June 11, 1997 Received: June 11, 1997

Dear Dr. Armstrong:

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, qood 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, 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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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510(k) Number (if known) __Not known

Device Name: _________________________________________________________________________________________________________________________________________________________________

SERUM - LOW/ELEVATED

## Indications For Use :

The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.

The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Makris

(Division Sign-Om
Division of Clinical Laboratory Devices
510(k) Number K972608

Prescription Use V (Per 21 CFR 801.109)

:: 【 川崎東雄東国際】

OR

Over-The-Counter Use (Optional format 1-2-96)