(168 days)
The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.
The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. Various other clinical chemistry assays are adaptable to the analyzer.
The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance.
The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions.
For in vitro diagnostic use only.
The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for a device named "RX Imola, (Clinical Chemistry Analyser), ISE Unit & Magnesium Test Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it must comply with. The "Indications for Use" section describes what the device does (e.g., runs tests for magnesium, sodium, potassium, chloride in serum, plasma, and urine) and who should use it, but it does not provide:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information on standalone performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed study information is typically found in the 510(k) submission itself or in scientific publications, not usually in the FDA clearance letter which primarily states the regulatory decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Pauline Armstrong QA/Regulatory Affairs Manager Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim BT29 4QY United Kingdom
MAR 3 I 2006
Trade/Device Name: RX Imola, (Clinical Chemistry Analyser), ISE Unit & Magnesium Test Kit Regulation Number: 21 CFR§ 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM, CGZ, JGS, JGJ, JJE
Dated: February 20, 2006
Received: February 22, 2006
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) I ms lotter with and your he FDA finding of substantial equivalence of your device to a legally promation in the 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, r you don't on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
Device Name:
RX Imola, (Clinical Chemistry Analyser), ISE Unit & Magnesium Test Kit
Indications For Use:
The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.
The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. Various other clinical chemistry assays are adaptable to the analyzer.
The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance.
The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions.
For in vitro diagnostic use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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)
Caitlin Brown
L 052914
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.