(30 days)
The Randox Laboratories Limited Inorganic Phosphorous Test Kit is an in vitro diagnostic reagent for the quantitative determination of inorganic phosphorous in serum. The method is based on the interaction of inorganic phosphorous with ammonium-molybdate in the presence of sulphuric acid to form a phosphomolybdate complex which is measured at 340nm. Measurements of inorganic phosphorous are used in the diagnosis and treatment of various disorders including, renal failure, hyper- and hypoparathyroidism and vitamin D deficiency. This test kit must be used by suitably qualified laboratory personnel, under appropriate laboratory conditions.
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This document is a 510(k) clearance letter from the FDA for a medical device, the "Randox Inorganic Phosphorous Test Kit." It is not a study report and therefore does not contain the detailed information requested about acceptance criteria, study design, or performance metrics.
The document does not provide the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Details on standalone algorithm performance.
- Specifics about the type of ground truth used (beyond implying a chemical reaction based on known inorganic phosphorous).
The document's purpose is to state that the FDA has reviewed the manufacturer's submission and determined the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It describes the intended use of the device: "The Randox Laboratories Limited Inorganic Phosphorous Test Kit is an in vitro diagnostic reagent for the quantitative determination of inorganic phosphorous in serum." It also briefly explains the methodology: "The method is based on the interaction of inorganic phosphorous with ammonium-molybdate in the presence of sulphuric acid to form a phosphomolybdate complex which is measured at 340nm."
To obtain the detailed information requested, one would need to review the original 510(k) submission (K974605) filed by Randox Laboratories, Ltd. to the FDA, which would contain the performance data and methodology used to demonstrate substantial equivalence.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AN - 9 100
Dr. P. Armstrong . Requlatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co. Antrim, United Kingdom BT29 4QY
K974605 Re : Randox Inorganic Phosphorous Regulatory Class: I Product Code: CEO December 5, 1997 Dated: December 10, 1997 Received:
Dear Dr. Armstrong:
requlations.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination-assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (SEIN 00), Child Corner if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of t Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of_______________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known)___NOT_KNOWN
INORGANIC PHOSPHOROUS Device Name
Indications For Use :
The Randox Laboratories Limited Inorganic Phosphorous Test Kit is an in vitro diagnostic reagent for the quantitative determination of inorganic phosphorous in serum. The method is based on the interaction of inorganic phosphorous with ammonium-molybdate in the presence of sulphuric acid to form a phosphomolybdate complex which is measured at 340nm. Measurements of inorganic phosphorous are used in the diagnosis and treatment of various disorders including, renal failure, hyper- and hypoparathyroidism and vitamin D deficiency.
This test kit must be used by suitably qualified laboratory personnel, under appropriate laboratory conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratices
K174605
510(k) Number .
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§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general 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.