PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30

K974858 · Diagnostic Chemicals , Ltd. · CEO · Jan 30, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974858
• Device Name: PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CEO · Clinical Chemistry
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate).

Device Story

Phosphorus-SL Assay is an in vitro diagnostic reagent for quantitative measurement of inorganic phosphorus in serum. Principle of operation: modification of the Daly and Ertingshausen technique (1972), which measures the unreduced phosphorus-molybdate complex rather than the reduced molybdenum blue complex. Used in clinical laboratory settings by trained laboratory personnel. Output is a quantitative concentration value of inorganic phosphorus. Results assist clinicians in diagnosing metabolic conditions related to phosphorus levels, such as renal failure, hyperparathyroidism, or rickets. Benefits include accurate monitoring of serum phosphorus to guide patient management and therapeutic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical assay. Principle: spectrophotometric measurement of unreduced phosphorus-molybdate complex. Reagent-based chemistry. No software, electronics, or connectivity.

Indications for Use

Indicated for quantitative determination of inorganic phosphorus in serum for in vitro diagnostic use to assist in the diagnosis of hyperphosphatemia (e.g., Vitamin D overdose, hypoparathyroidism, renal failure) or hypophosphatemia (e.g., rickets, hyperparathyroidism, Fanconi Syndrome).

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

JAN 30 003

Karen Callbeck, R.T.B.Sc. · Requlatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

Re : K974858 Phosphorus-SL Assay Requlatory Class: CEO Product Code: Dated: December 19, 1997 Received: December 29, 1997

Dear Ms. Callbeck:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ 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 regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of ----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 requlation 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.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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## 510(k) Number (if known): K974858

Device Name: Phosphorus-SL Assay

## Indications for Use:

For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate). (1)

The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique (2).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K074258

**Prescription Use**
(Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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