UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

K981573 · United Biotech, Inc. · JFH · Sep 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981573
• Device Name: UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
• Applicant: United Biotech, Inc.
• Product Code: JFH · Clinical Chemistry
• Decision Date: Sep 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1020
• Device Class: Class 2

Intended Use

The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)

Device Story

UBI MAGIWEL PAP CM-301 is a solid-phase enzyme-linked immunosorbent assay (ELISA) kit. It measures prostatic acid phosphatase (PAP) levels in human serum samples. Used in clinical laboratory settings by professional personnel. The assay provides quantitative results to assist clinicians in managing prostate cancer patients and monitoring the efficacy of therapeutic interventions. The device functions as an in vitro diagnostic tool.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) notification.

Technological Characteristics

Solid-phase enzyme-linked immunosorbent assay (ELISA) kit for quantitative measurement of PAP in human serum.

Indications for Use

Indicated for the quantitative measurement of prostatic acid phosphatase (PAP) in human serum to aid in the management and monitoring of therapeutic treatment effectiveness in patients diagnosed with prostate cancer. For professional use only.

Regulatory Classification

Identification

An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 5 1998

Sharon Sun . United Biotech, Inc. 110 Pioneer Way #C Mountain View, California 94041-1517

K981573 Re: UBI MAGIWELTM PAP EIA Quantitative Regulatory Class: II Product Code: JFH Dated: August 25, 1998 Received: August 28, 1998

Dear Ms. Sun:

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 aqainst 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. 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 requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.

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Paqe 2

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 qeneral 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): K981573

DEVICE NAME: Prostatic Acid Phosphatase (PAP), 75JFH

INDICATIONS FOR USE:

The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use | <div style="text-align:left;">✓</div> | OR | Over-The-Counter-Use |
|----------------------|---------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | k981573 |
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|---------------|---------|