RANDOX INORGANIC PHOSPHOROUS

K974605 · Randox Laboratories, Ltd. · CEO · Jan 9, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974605
• Device Name: RANDOX INORGANIC PHOSPHOROUS
• Applicant: Randox Laboratories, Ltd.
• Product Code: CEO · Clinical Chemistry
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended 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.

Device Story

In vitro diagnostic reagent kit for quantitative serum inorganic phosphorous measurement. Principle: chemical reaction of inorganic phosphorous with ammonium-molybdate in sulphuric acid to form a phosphomolybdate complex; absorbance measured at 340nm. Used in clinical laboratory settings by qualified personnel. Output: quantitative phosphorous concentration. Clinical utility: aids diagnosis/treatment of renal failure, parathyroid disorders, and vitamin D deficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit. Chemical principle: ammonium-molybdate/sulphuric acid reaction. Detection method: spectrophotometry at 340nm. Analyte: inorganic phosphorous in serum.

Indications for Use

Indicated for the quantitative determination of inorganic phosphorous in serum for the diagnosis and treatment of disorders including renal failure, hyperparathyroidism, hypoparathyroidism, and vitamin D deficiency. For use by qualified laboratory personnel.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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