(208 days)
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No
The summary describes a turbidimetric assay kit for measuring albumin in urine, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) test for measuring albumin in urine. It is used as an aid in diagnosis and does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "Measurement of albumin in human urine is an aid in the diagnosis of renal disease." This explicitly indicates the device's role in diagnosis.
No
The device is described as a "Human Microalbumin kit for use on SPAPLUS kit" and is intended for use with a "SPAPLUS turbidimetric analyser." This strongly suggests the device includes physical components (a kit and an analyzer) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use only." This is a clear and direct statement indicating the device's intended purpose.
- "intended for the quantitative measurement of human albumin in human urine" This describes a test performed on a biological sample (urine) outside of the body (in vitro).
- "Measurement of albumin in human urine is an aid in the diagnosis of renal disease." This indicates the diagnostic purpose of the test results.
N/A
Intended Use / Indications for Use
The Human Microalbumin kit for use on SPAPLUS kit is intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.
Product codes
DCF
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
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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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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 circular arrangement of text surrounding a central emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The emblem features a stylized design of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
THE BINDING SITE GROUP LTD MARIANNE SENDER REGULATORY AFFAIRS SPECIALIST 8 CALTHORPE ROAD. BIRMINGHAM B15 1QT, GREAT BRITAIN
Re: K143118
Trade/Device Name: Human Microalbumin kit for use on SPAPLUS kit Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: II Product Code: DCF Dated: April 17, 2015 Received: April 21, 2015
Dear Ms.Marianne Sender:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143118
Device Name
Human Microalbumin kit for use on SPAPLUS kit
Indications for Use (Describe)
The Human Microalbumin kit for use on SPAPLUS kit is intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
ं
Over-The-Counter Use (21 CFR 801 Subpart C)
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