ALKALINE PHOSPHATASE LIQUID REAGENT

K011599 · Jas Diagnostics, Inc. · CJE · Jul 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011599
• Device Name: ALKALINE PHOSPHATASE LIQUID REAGENT
• Applicant: Jas Diagnostics, Inc.
• Product Code: CJE · Clinical Chemistry
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

Intended for the In Vitro, quantitative determination of alkaline phosphatase in human serum on automated chemistry analyzers. Alkaline phosphatase measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Story

JAS Alkaline Phosphatase Liquid Reagent is an in vitro diagnostic reagent for quantitative measurement of alkaline phosphatase in human serum. Used on automated chemistry analyzers in clinical laboratory settings. Reagent reacts with serum samples to produce measurable changes proportional to alkaline phosphatase activity. Results assist clinicians in diagnosing and monitoring liver, bone, parathyroid, and intestinal disorders. Device is intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance and intended use comparison.

Technological Characteristics

Liquid reagent formulation for in vitro diagnostic use. Designed for compatibility with automated chemistry analyzers. Principle of operation involves enzymatic activity measurement in human serum.

Indications for Use

Indicated for the in vitro, quantitative determination of alkaline phosphatase in human serum for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. For prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 0 2001

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

Re: 510(k) Number: K011599 Trade/Device Name: JAS Alkaline Phosphatase Liquid Reagend Regulation Number: 862.1050 Regulatory Class: Class II Product Code: CJE Dated: May 1, 2001 Received: May 24, 2001

Dear Mr. Johnson:

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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin marketing your device of your device to a legally marketed notification. The FDA Inding of Substantal oqui facility of 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 If you desire specific advice for your devices), please contact the Office of Compliance at vour device additionally 809.10 for in vito diagnostic as now, promotion and advertising of your device, [phone]. Additionally, for questions on [phone]. Also, please note the regulation please contact the Office of Comphano at (30 c) 0 . 1 cation" (21CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notifical from the Division of S entitled, "Misbranding by Eleitle co permanel and may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained (201) 413, 659 information on your responsibilities must in 110000 638-2041 or [phone] or at its
Manufacturers Assistance at its toll-free number [phone] or [phone] or 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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Page 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: JAS - Alkaline Phosphat Indications for Use:

Intended for the In Vitro, quantitative determination of alkaline phosphatase in human serum on automated chemistry analyzers.

Alkaline phosphatase measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Ared Lacy

(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)