(168 days)
Not Found
Not Found
No
The document describes a standard automated clinical chemistry analyzer and does not mention any AI or ML capabilities.
No
The document states that the device is an "Automated Clinical Chemistry Analyzer" used for "in vitro diagnostic use only." It's used to measure substances in patient samples to aid in diagnosis and treatment, but it does not administer therapy directly.
Yes
The device is described as an "Automated Clinical Chemistry Analyzer" used to "run tests such as magnesium in serum and plasma samples" and the "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia." It also states the "ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride... for use in diagnosis and treatment of electrolyte imbalance." The "Intended Use / Indications for Use" section further specifies "For in vitro diagnostic use only."
No
The device description explicitly states it is a "fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit" and mentions hardware components like the analyzer itself and the ISE Unit, in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software."
- "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."
- "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."
- "For in vitro diagnostic use only."
These statements clearly indicate that the device is intended to be used to examine specimens derived from the human body (serum, plasma, urine) to provide information for the diagnosis and treatment of medical conditions. The final statement "For in vitro diagnostic use only" is a definitive confirmation.
N/A
Intended Use / 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.
Product codes
CEM, CGZ, JGS, JGJ, JJE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
suitably qualified personnel, under appropriate laboratory conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "U.S. Department of Health & Human Services" is written around the circular border of the logo.
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).
1
Page 2 -
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
2
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