INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02

K991867 · A.P. Total Care, Inc. · CEO · Aug 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991867
• Device Name: INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
• Applicant: A.P. Total Care, Inc.
• Product Code: CEO · Clinical Chemistry
• Decision Date: Aug 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro determination of inorganic phosphate in serum, or plasma.

Device Story

Inorganic Phosphorus (IP) reagents (product Nos. 112-01, 112-02) are in vitro diagnostic reagents used for the quantitative determination of inorganic phosphate in serum or plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The reagents facilitate chemical analysis of patient samples to measure phosphate levels, which are then used by healthcare providers to assist in the diagnosis and management of various metabolic and renal conditions. The device is a chemical reagent kit; it does not involve electronic processing, software, or automated algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagent kit for phosphate determination. No electronic components, software, or specific materials of construction described.

Indications for Use

Indicated for the in vitro determination of inorganic phosphate in human serum or plasma. No specific patient population, age, or contraindications provided.

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

AUG - 2 1999

A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. P.O. Box 6216 Bridgeport, Connecticut 06606

Re: K991867 Trade Name: Inorganic Phosphorus (IP) Regulatory Class: I reserved Product Code: CEO Dated: May 27, 1999

Received: June 1, 1999

Dear Mr. Leon:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Toutman

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): 599 /84)

## DEVICE NAME: INORGANIC PHOSPHORUS

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## INDICATIONS FOR USE:

The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

copy of Device Fuglustion (OFD)

Concurrence of CDRH, Office of Device Evaluation (OED)

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter-Use (Optional Format 1-2-96)