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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Urine/CSF Protein assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance (UPro on AEROSET)
Method Comparison (Correlation)	Acceptable correlation with predicate device (Boehringer Mannheim Urinary/CSF Protein on Hitachi 717 Analyzer). Implicitly, this means high correlation coefficients and slopes close to 1 with Y-intercepts close to 0.	Urine Application: Correlation Coefficient = 0.992, Slope = 1.065, Y-intercept = -0.264 mg/dLCSF Application: Correlation Coefficient = 0.9965, Slope = 0.985, Y-intercept = 5.762 mg/dL
Precision	Acceptable within-run, between-run, and between-day precision for control materials. Implicitly, low %CV values.	Urine Application (Total %CV): Level 1/Panel 201 = 4.8%, Level 2/Panel 202 = 2.5%CSF Application (Total %CV): Level 1/Panel 301 = 2.4%, Level 2/Panel 302 = 1.5%
Linearity	Linearity over a clinically relevant range.	Linear up to 200 mg/dL
Limit of Quantitation (Sensitivity)	Clinically acceptable limit for detection and quantification.	4.8 mg/dL

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size (number of patient samples) used for the method comparison or precision studies.
The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is implied to be clinical samples since it refers to "human urine or cerebrospinal fluid."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This is not applicable as the study involves a comparative performance analysis against a legally marketed predicate device (Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer), not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is effectively the results obtained from the predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as this is a performance comparison of an in vitro diagnostic assay against a predicate device, not a study involving expert interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This device is an in vitro diagnostic assay, not an imaging or interpretive device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the performance characteristics (method comparison, precision, linearity, sensitivity) are presented as standalone performance of the UPro assay on the AEROSET system. There is no human interaction described in the performance evaluation of the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the UPro assay was established by comparison to a legally marketed predicate device, the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer. The performance of the predicate device serves as the reference standard.

8. The Sample Size for the Training Set:

The document does not provide information about a training set. As an in vitro diagnostic assay, the "training" would typically refer to the development and optimization of the reagent and assay protocol, rather than a machine learning training set with a specific sample size.

9. How the Ground Truth for the Training Set Was Established:

Not applicable in the context of this traditional in vitro diagnostic assay. The ground truth for development and optimization would have been based on established analytical chemistry principles and potentially reference methods, but this type of detail is not typically included in a 510(k) summary.

Summary

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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:

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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Page 2

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:

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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Regulation Number and Section

§ 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.