(159 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
This device is intended for in vitro diagnostic use for the quantitative determination of low-level albumin in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "This product is to be used in a diagnostic laboratory setting" and "It is intended for in vitro diagnostic use only." It also mentions "quantitative determination of low level albumin in human Urine" and its use as an "indicator of early glomerular disease," which are diagnostic purposes.
No
The 510(k) summary describes an in vitro diagnostic device for measuring albumin in urine, which inherently involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This product is to be used in a diagnostic laboratory setting..."
- "...for the quantitative determination of low level albumin in human Urine."
- "It is intended for in vitro diagnostic use only."
These points clearly indicate that the device is intended for use outside of the body (in vitro) to diagnose or aid in the diagnosis of a condition (measuring albumin in urine to predict diabetic nephropathy and indicate early glomerular disease).
N/A
Intended Use / Indications for Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.
Product codes
DDZ; JIT
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
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Indicated Patient Age Range
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Intended User / Care Setting
diagnostic laboratory setting, by qualified laboratory technologists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
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 § 866.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, with three lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 8 2003
Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, MI 48146
Re: K023860
Trade/Device Name: Microalbumin Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DDZ; JIT Dated: February 10, 2003 Received: February 12, 2003
Dear Mr. Jamison:
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. Iisting 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 Sutman
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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510 (k) Number (if known):
K 023860
Device Name: Microalbumin
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.
Han Cooper
(Division Sior-Off)
Division o Clinical Laboratory Devices
510(k) Number K023860
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Counter Use (Per 21 CFR 801.109)
OR
Over the
(Optional Format 1-2-96)