(183 days)
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.
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.
This is a 510(k) premarket notification for a medical device called "Randox Liquid Urine Controls, Level 2 and Level 3". The document is a clearance letter from the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria with the level of detail requested.
The document states that the FDA reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in the 510(k) submission, which would have included performance data, but that data is not present in this FDA clearance letter.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and the reported device performance: This information would be in the manufacturer's performance study report, not the FDA clearance letter.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable for a quality control material.
- If a standalone study was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not applicable for a quality control material.
- How the ground truth for the training set was established: Not applicable for a quality control material.
The document indicates the device's intended use is for in vitro diagnostic quality control of various analytes on clinical chemistry systems. The FDA clearance means they believe the device performs similarly to existing legally marketed devices for this purpose, based on the submitted data. However, the details of that supporting data are not in this provided 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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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)
Dus
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110906/
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.