(131 days)
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No
The device description and performance studies describe a standard turbidimetric clinical chemistry assay without any mention of AI or ML.
No
This device is an in vitro diagnostic assay used for the quantitative determination of protein in human urine or CSF, which aids in diagnosis. It does not provide treatment or therapy.
Yes
The device is an in vitro diagnostic assay used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF), and the output is explicitly stated as being used in the diagnosis and treatment of disease conditions.
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a chemical reaction and turbidimetric procedure, indicating it is a physical reagent or kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is used for the "quantitative determination of protein in human urine or cerebrospinal fluid (CSF)". This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information for diagnosis and treatment.
- Device Description: The description further clarifies that it is an "in vitro diagnostic assay".
- Performance Studies: The performance studies compare the device to a "predicate device" which is also an IVD (K913615; Boehringer Mannheim® Urinary/CSF Protein assay on the Hitachi® 717 Analyzer). This comparison is a common requirement for demonstrating substantial equivalence for new IVD devices.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to analyze human biological samples for diagnostic purposes, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the AEROSET System. Identification of urinary protein 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.
Product codes
75JGQ
Device Description
Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF). The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 nm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.
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
Comparative performance studies were conducted using the AEROSET™ Analyzer. The Urine/CSF Protein assay method comparison yielded acceptable correlation with the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer. For the urine application, the correlation coefficient = 0.992, slope = 1.065, and Y-intercept = - 0.264 mg/dL. For the CSF application, the correlation coefficient = 0.9965, slope = 0.985, and Y-intercept = 5.762 mg/dL. Precision studies were conducted using the Urine/CSF Protein assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the urine application, the total %CV for Level 1/Panel 201 is 4.8% and Level 2/Panel 202 is 2.5%. For the CSF application, the total %CV for Level 1/Panel 301 is 2.4% and Level 2/Panel 302 is 1.5%. The Urine/CSF Protein assay is linear up to 200 mg/dL. The limit of quantitation (sensitivity) for the Urine/CSF Protein assay is 4.8 mg/dL. These data demonstrate that the performance of the Urine/CSF Protein assay is substantially equivalent to the performance of the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer.
Key Metrics
For the urine application, the correlation coefficient = 0.992, slope = 1.065, and Y-intercept = - 0.264 mg/dL. For the CSF application, the correlation coefficient = 0.9965, slope = 0.985, and Y-intercept = 5.762 mg/dL. For the urine application, the total %CV for Level 1/Panel 201 is 4.8% and Level 2/Panel 202 is 2.5%. For the CSF application, the total %CV for Level 1/Panel 301 is 2.4% and Level 2/Panel 302 is 1.5%. The limit of quantitation (sensitivity) for the Urine/CSF Protein assay is 4.8 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1635 Total protein test system.
(a)
Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.(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 § 862.9.
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K981682 006
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 12, 1998 |
|---|---|
| Device Trade or Proprietary Name: | UPro |
| Device Common/Usual Name or Classification Name: | Urine/CSF Protein |
| Classification Number/Class: | 75JGQ/Class I |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Test Description:
Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF). The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 nm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.
Section II Page 1
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Substantial Equivalence:
The Urine/CSF Protein assay is substantially equivalent to the Boehringer Mannheim® Urinary/CSF Protein assay on the Hitachi® 717 Analyzer (K913615).
Both assays vield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of protein in urine or . cerebrospinal fluid.
- Both assays yield similar clinical results. .
Differences:
- There is a difference in the wavelength of which the two methods are read. .
Intended Use:
The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the AEROSET System.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ Analyzer. The Urine/CSF Protein assay method comparison yielded acceptable correlation with the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer. For the urine application, the correlation coefficient = 0.992, slope = 1.065, and Y-intercept = - 0.264 mg/dL. For the CSF application, the correlation coefficient = 0.9965, slope = 0.985, and Y-intercept = 5.762 mg/dL. Precision studies were conducted using the Urine/CSF Protein assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the urine application, the total %CV for Level 1/Panel 201 is 4.8% and Level 2/Panel 202 is 2.5%. For the CSF application, the total %CV for Level 1/Panel 301 is 2.4% and Level 2/Panel 302 is 1.5%. The Urine/CSF Protein assay is linear up
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to 200 mg/dL. The limit of quantitation (sensitivity) for the Urine/CSF Protein assay is 4.8 mg/dL. These data demonstrate that the performance of the Urine/CSF Protein assay is substantially equivalent to the performance of the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer.
Conclusion:
The Urine/CSF Protein assay is substantially equivalent to the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Urine/CSF Protein 510(k) September 15, 1998 UPro12.lwp
Section II Page 3
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected appearance. Encircling the profile design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 21 1998
Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981682 Re : UPro for Aeroset Requlatory Class: I Product Code: JGQ Dated: July 17, 1998 Received: July 21, 1998
Dear Mr. Littlefield:
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 against 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 regulation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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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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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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): Ky 8 / 68.2
Urine/CSF Protein Device Name:
Indications For Use:
The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the AEROSET System. Identification of urinary protein 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.
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Division Sign-Off)
Division of Clinical 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V Over-The-Counter Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
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