RANDOX LIQUID CRP CONTROLS

K040351 · Randox Laboratories, Ltd. · JJX · Mar 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040351
• Device Name: RANDOX LIQUID CRP CONTROLS
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Randox Laboratories Ltd. CRP Controls are liquid controls containing human recombinant CRP in a stabilized protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Liquid control material containing recombinant human CRP in stabilized protein matrix; used to monitor accuracy/precision of clinical chemistry immunoturbidimetric CRP assays. Operated by qualified laboratory personnel in clinical settings. Product provides known concentration levels (Level II ~20 mg/L, Level III ~150 mg/L) to verify assay performance against CRM470 standards. Healthcare providers use output to validate laboratory testing procedures and ensure reliable patient results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies support 18-month shelf life at 2-8 °C. Value assignment validated via comparison of test lots against master lots stored at -80 °C using 10 replicates.

Technological Characteristics

Liquid control material; recombinant human CRP in stabilized protein matrix. Traceable to CRM470. Storage 2-8 °C. Stability 18 months unopened/opened.

Indications for Use

Indicated for use as quality control materials to monitor the accuracy and precision of C-Reactive Protein (CRP) assays in clinical laboratory settings. Intended for use by qualified laboratory personnel.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 2 2004

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

k040351 Re:

> Trade/Device Name: Liquid C-Reactive Protein Controls (Levels II and III) Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class I Product Code: JJX Dated: January 29, 2004 Received: February 12, 2004

Dear Dr. Armstrong:

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 vours.

Jean M. Cooper, MS, DVM.

Yean 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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510(k) Number (if known) NOT KNOWN KOYO351

LIQUID C-REACTIVE PROTEIN CONTROLS (LEVELS II AND III) Device Name:

## Indications For Use :

The Randox Laboratories Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations.

The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Division Sign-Off

vision Sian-

Office of In Vitro Diagno Device Evaiuation an 510(k)

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