(175 days)
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No
The device description details a standard turbidimetric clinical chemistry assay and does not mention any AI or ML components. The performance studies focus on traditional analytical metrics like correlation and precision.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of protein in human urine or cerebrospinal fluid, which aids in diagnosis and treatment but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "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" and "CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous system." This indicates its role in identifying and characterizing disease states, which is the definition of a diagnostic device. The "Device Description" also refers to it as an "in vitro diagnostic assay."
No
The device is an in vitro diagnostic assay, which is a reagent kit used with an analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the "quantitative determination of protein in human urine or cerebrospinal fluid (CSF)". It also details how this information is used in the "diagnosis and treatment of disease conditions". This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The "Device Description" section further clarifies that it is an "in vitro diagnostic assay". It describes the method used (turbidimetric procedure) and the sample types analyzed (human urine or CSF), all of which are characteristic of IVDs.
- Performance Studies: The "Summary of Performance Studies" and "Key Metrics" sections provide data on the performance of the assay, including correlation with a predicate device and precision. This type of performance evaluation is standard for IVDs to demonstrate their accuracy and reliability for clinical use.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K913615) indicates that this device is being compared to a previously cleared IVD, which is a common pathway for regulatory submission of new IVDs.
The information provided clearly demonstrates that this device is designed and intended for in vitro diagnostic use.
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 ALCYON™ Analyzer. 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. CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous system.
Product codes (comma separated list FDA assigned to the subject device)
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) on the ALCYON™ Analyzer. 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 mm. 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine or cerebrospinal fluid (CSF)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the ALCYON™ 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 = 0.995, slope = 0.943, and Y-intercept = 5.146 mg/dL. For the CSF application, the correlation coefficient = 0.981, slope = 0.995, and Y-intercept = 1.184 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. The total %CV for Level 1/Panel 131 is 5.1% and Level 2/Panel 132 is 4.5% for the urine application. The total %CV for Level 1/Panel 601 is 2.6% and Level 2/Panel 602 is 2.1% for the CSF application. The Urine/CSF Protein assay is linear from 10 to 200 mg/dL. The limit of quantitation (sensitivity) for the Urine/CSF Protein assay is 10 mg/dL. The functional sensitivity was based on the lowest calibrator (standard) value used in the determination of the Urine/CSF Protein Linearity (standards ranged from 10 to 200 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 (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation coefficient = 0.995, slope = 0.943, and Y-intercept = 5.146 mg/dL for urine application.
The correlation coefficient = 0.981, slope = 0.995, and Y-intercept = 1.184 mg/dL for CSF application.
The total %CV for Level 1/Panel 131 is 5.1% and Level 2/Panel 132 is 4.5% for the urine application.
The total %CV for Level 1/Panel 601 is 2.6% and Level 2/Panel 602 is 2.1% for the CSF application.
Linearity from 10 to 200 mg/dL.
Limit of quantitation (sensitivity): 10 mg/dL.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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1 1998
ADD CLIN CHEM
OCT
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) 518-7861 Fax (972) 753-3367
198129
| Date of Preparation of this Summary: | September 29, 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: K981295
Test Description:
Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the ALCYON™ Analyzer. 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 mm. 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.
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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 yield 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.
Intended Use:
The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF).
Performance Characteristics:
Comparative performance studies were conducted using the ALCYON™ 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 = 0.995, slope = 0.943, and Y-intercept = 5.146 mg/dL. For the CSF application, the correlation coefficient = 0.981, slope = 0.995, and Y-intercept = 1.184 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. The total %CV for Level 1/Panel 131 is 5.1% and Level 2/Panel 132 is 4.5% for the urine application. The total %CV for Level 1/Panel 601 is 2.6% and Level 2/Panel 602 is 2.1% for the CSF application. The Urine/CSF Protein assay is linear from 10 to 200 mg/dL. The limit of quantitation (sensitivity) for the Urine/CSF Protein assay is 10 mg/dL. The functional sensitivity was based on the lowest calibrator (standard) value used in the determination of the Urine/CSF Protein Linearity (standards ranged
Urine/CSF Protein 510(k) September 29, 1998 MicroproteinFinal3.1wp
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from 10 to 200 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 5 10(k) September 29, 1998
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981295 Re : Alcyon Urine/CSF Protein Regulatory Class: I Product Code: JGQ Dated: August 13, 1998 Received: August 14, 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 adulterationer would
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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
premarket notification" (21 CFR 807.97). Other general 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): _ £98 1295
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 ALCYON™ Analyzer. 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. CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous system.
Image /page/5/Picture/4 description: The image shows a handwritten note with the word "prescription" written diagonally. There is a box with an "X" through it, and a signature or initials are present to the right of the box. The writing appears to be in black ink on a white background.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981295
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)