RANDOX CALIBRATION SERUM

K053153 · Randox Laboratories, Ltd. · JIX · Jan 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053153
• Device Name: RANDOX CALIBRATION SERUM
• Applicant: Randox Laboratories, Ltd.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.

Device Story

Randox Calibration Serum is a multi-analyte, two-level lyophilized human serum product; used to calibrate clinical chemistry assays on manual or automated analyzers. Input consists of lyophilized human serum base spiked with stock solutions for 42 analytes. Device provides known concentrations/activities for instrument calibration. Used in clinical laboratory settings by laboratory technicians/professionals. Output is a reference standard used to adjust instrument response to ensure accurate patient sample measurement. Benefits include standardized, traceable calibration across diverse clinical chemistry platforms.

Clinical Evidence

No clinical data. Bench testing only. Stability established via longitudinal assay of reconstituted samples at 6-48 months (closed vial) and various temperature/time intervals (open vial). Value assignment validated via consensus mean target values from ~3000 laboratories and in-house testing against master lots and QC materials.

Technological Characteristics

Lyophilized human serum matrix; 42 analytes; two-level concentration. Reconstituted stability: 8 hours at 25°C, 7 days at 4°C, 1 month at -20°C. Closed vial shelf-life: 3 years at 2-8°C. Human source material tested negative for HBsAg, HCV, and HIV-1/2.

Indications for Use

Indicated for use as a calibration serum in clinical chemistry assays for the calibration of manual and automated clinical chemistry analyzers. No specific patient population or contraindications defined.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 2006

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

Re: k053153

Trade/Device Name: Randox Calibration Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 28, 2005 Received: November 15, 2005

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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. 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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## Indications for Use

510(k) Number (if known): NOT KNOWN

CALIBRATION SERUM LEVELS 2 & 3 Device Name:

Indications For Use:

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

Carol Benam

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## CALIBRATION SERUM LEVELS 2 & 3 - Catalogue Numbers CAL2350 & CAL2351

| Analyte | Analyte |
|----------------------------------|---------------------|
| Albumin | Gamma-GT |
| Aldolase | GLDH |
| Alkaline Phosphatase | Glucose |
| ALT (GPT) | α-HBDH |
| Amylase Pancreatic | Iron |
| Amylase Total | Lactate |
| Acid Phosphatase (non-prostatic) | LAP |
| Acid Phosphatase (Prostatic) | LD (LDH) |
| Acid Phosphatase (Total) | Lipase |
| AST (GOT) | Lithium |
| Bile Acids | Magnesium |
| Bicarbonate | Osmolality |
| Bilirubin Direct | Phosphate Inorganic |
| Bilirubin Total | Potassium |
| Calcium | Protein Total |
| Cholesterol | Sodium |
| Chloride | TIBC |
| Cholinesterase | Triglycerides |
| CK Total | Uric Acid (Urate) |
| Copper | Urea |
| Creatinine | Zinc |
| D-3-Hydroxybutyrate | |

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Carol Benson

K053/53