ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

K991762 · A.P. Total Care, Inc. · CJE · Sep 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991762
• Device Name: ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
• Applicant: A.P. Total Care, Inc.
• Product Code: CJE · Clinical Chemistry
• Decision Date: Sep 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

This Alkaline Phosphatase procedure is intended for Invitro Diagnostic use in the automated, in serum. Measurments of Alkaline quantitative determination of Alkaline Phosphatase or its isoenzymes are use in the diagnostics and treatment of liver, bone, Phosphatase parathyroid, and intestinal diseases.

Device Story

Alkaline Phosphatase reagent kit for quantitative determination of enzyme levels in serum; intended for use in automated clinical chemistry analyzers. Operates via in vitro diagnostic chemical assay. Used in clinical laboratory settings by trained laboratory personnel. Provides quantitative measurement of Alkaline Phosphatase activity; results assist clinicians in diagnosing and monitoring liver, bone, parathyroid, and intestinal disorders. Benefits patient by providing objective biochemical data for clinical decision-making regarding metabolic and organ-specific disease states.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for automated serum analysis. Principle of operation based on enzymatic chemical assay for Alkaline Phosphatase quantification. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of Alkaline Phosphatase or its isoenzymes in serum for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. For in vitro diagnostic use.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP -2 1995

A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, Connecticut 06606

Re: K991762 Trade Name: Alkaline Phosphatase Regulatory Class: II Product Code: CJE Dated: July 12, 1999 Received: July 26, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Sutman

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): K991762

# DEVICE NAME: ALKALINE PHOSPHATASE

## INDICATIONS FOR USE:

This Alkaline Phosphatase procedure is intended for Invitro Diagnostic use in the automated, in serum. Measurments of Alkaline quantitative determination of Alkaline Phosphatase or its isoenzymes are use in the diagnostics and treatment of liver, bone, Phosphatase parathyroid, and intestinal diseases.

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devless 510(k) Number_K991762

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

### 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)