(647 days)
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Not Found
No
The summary describes a quantitative assay for albumin in urine, which is a standard laboratory test and does not mention any AI/ML components or image processing.
No
The device is an in vitro diagnostic assay used for the quantitation of intact albumin in human urine, which aids in identifying patients who may need further testing for kidney or intestinal disease. It does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use in the quantitation of intact albumin in human urine" and "aids in the identification of patients who may warrant further testing for kidney or intestinal disease." This directly indicates its diagnostic purpose.
No
The device is an in vitro diagnostic assay intended for the quantitation of intact albumin in human urine. This description strongly suggests a physical test kit or laboratory equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Total Intact Albumin Assay... is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine."
This statement directly identifies the device as being used for diagnostic purposes outside of the body (in vitro) using a human sample (urine).
N/A
Intended Use / 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.
Product codes
JIQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes, and it is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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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Page of of
| Labels | Values |
|---|---|
| 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
prescription use✓
(Optional Format 3-10-98)