AUSAM TOTAL ALBUMIN ASSAY

K013643 · Ausam Biotecthnologies, Inc. · JIQ · Aug 14, 2003 · Clinical Chemistry

Device Facts

• Record ID: K013643
• Device Name: AUSAM TOTAL ALBUMIN ASSAY
• Applicant: Ausam Biotecthnologies, Inc.
• Product Code: JIQ · Clinical Chemistry
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.

Device Story

The AusAm Total Intact Albumin Assay is an in vitro diagnostic test for quantifying intact albumin in human urine samples. It is used in clinical laboratory settings to assist healthcare providers in identifying patients who may require further diagnostic investigation for kidney or intestinal disease. The assay provides a quantitative measurement of albumin, which clinicians use to inform clinical decision-making regarding patient screening and follow-up testing. The device is intended for prescription use.

Technological Characteristics

In vitro diagnostic assay for quantitative measurement of intact albumin in human urine. Classified as a urinary protein or albumin non-quantitative test system (21 CFR 862.1645).

Indications for Use

Indicated for in vitro diagnostic quantitation of intact albumin in human urine to aid in identifying patients requiring further evaluation for kidney or intestinal disease.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 4 2003

Mr. James McCullough CEO AusAm Biotechnologies Inc. 528 Arizona Ave, Suite 319 Santa Monica, CA 90401

Re: k013643

Trade/Device Name: AusAm Total Intact Albumin Assay, AusAm Microalbumin Plus Urinary Albumin Assay

Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary Protein or Albumin Non-Quantitative Test System Regulatory Class: Class I Product Code: JIQ Dated: May 14, 2003 Received: May 16, 2003

Dear Mr.McCullough

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|----------------------------------|
| 510(k) Number (if known): | K013643 |
| Device Name: | Ausam Total Intact Albumin Assay |
| Indications for Use: | |

The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.

Jean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K013643

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Concurrence of CDRH, Office of Device Evaluation (ODE)

prescription use✓

(Optional Format 3-10-98)