RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

K110904 · Randox Laboratories, Ltd. · JJY · Sep 30, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110904
• Device Name: RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Randox Liquid Urine Controls Level 2 and Level 3 are liquid controls containing amylase, calcium, chloride, cortisol, creatinine, glucose, hCG pregnancy, magnesium, microalbumin, osmolality, pH, inorganic phosphate, potassium, total protein, sodium, specific gravity, urea, and uric acid. They have been developed for in vitro diagnostic use in the quality control of amylase, calcium, chloride, cortisol, creatinine, glucose, hCG pregnancy, magnesium, microalbumin, osmolality, pH, inorganic phosphate, potassium, total protein, sodium, specific gravity, urea, and uric acid assays on various clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Liquid Urine Controls (Level 2 and Level 3) are liquid, ready-to-use quality control materials. They contain specific analytes (Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea, Uric Acid). Used in clinical laboratories to monitor the performance and precision of clinical chemistry analyzers. Laboratory personnel process these controls alongside patient samples to verify assay accuracy and identify potential systematic errors. The output is a measured value compared against established target ranges; if results fall outside expected limits, the clinician or technician identifies the need for system recalibration or troubleshooting before reporting patient results. Benefits include ensuring reliable diagnostic testing and patient safety.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed 2-year shelf life and 30-day open-vial stability at 2-8°C. Value assignment validated through in-house analysis and external studies across 9 instrument families in 203 laboratories.

Technological Characteristics

Ready-to-use liquid human urine matrix. Analytes: amylase, calcium, chloride, cortisol, creatinine, glucose, hCG, magnesium, microalbumin, osmolality, pH, inorganic phosphorus, potassium, total protein, sodium, specific gravity, urea, uric acid. Storage: 2-8°C. Compatible with various clinical chemistry analyzers (Abbott, Beckman, Roche, Siemens, etc.).

Indications for Use

Indicated for use as quality control material for monitoring the precision of clinical chemistry assays for Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea, and Uric Acid in urine samples.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. Department of Health & Human Services USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 30 2011

Randox Laboratories Limited c/o Dr. Pauline Armstrong 55 Diamond Road Crumlin, Antrim United Kingdom BT29 4QY

Re: k110904

Trade/Device Name: Randox Liquid Urine Controls, Level 2 and Level 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: 13 September 2011 Received: 16 September 2011

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 class II (Special Controls), 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): medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

jz

Courtney H. Lias, 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): K110904

Device Name: Randox Liquid Urine Controls Level 2 and Level 3

Indication For Use:

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The Randox Liquid Urine Controls Level 2 and Level 3 are liquid controls containing Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid. They have been developed for in vitro diagnostic use in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid assays on various clinical chemistry systems.

This in vitro diagnostic device is intended for prescription use only.

Prescription Use And/Or Over the Counter Use

(21 CFR Part 801 Subpart D) Subpart C)

(21 CFR Part 801

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

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

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110906/