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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott Urine/CSF Protein assay, framed by the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a typical quantitative sense (e.g., "correlation coefficient must be > 0.95"). Instead, it states that the new device is "substantially equivalent" to the predicate, and this is demonstrated by the reported performance characteristics. The acceptance is implicitly met if the reported performance is considered "acceptable correlation" and "substantially equivalent" to the predicate.

Performance Metric	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (Abbott Urine/CSF Protein)
Urine Application
Correlation Coefficient (vs. Predicate)	Acceptable correlation (e.g., very high)	0.995
Slope (vs. Predicate)	Close to 1.0	0.943
Y-intercept (vs. Predicate)	Close to 0	5.146 mg/dL
Total %CV (Level 1 Control)	Low variability (e.g., within typical assay expectations)	5.1%
Total %CV (Level 2 Control)	Low variability	4.5%
Linearity Range	Consistent with clinical needs	10 to 200 mg/dL
Limit of Quantitation (Sensitivity)	Consistent with clinical needs	10 mg/dL
CSF Application
Correlation Coefficient (vs. Predicate)	Acceptable correlation (e.g., very high)	0.981
Slope (vs. Predicate)	Close to 1.0	0.995
Y-intercept (vs. Predicate)	Close to 0	1.184 mg/dL
Total %CV (Level 1 Control)	Low variability	2.6%
Total %CV (Level 2 Control)	Low variability	2.1%
Linearity Range	Consistent with clinical needs	10 to 200 mg/dL (Implied from general linearity statement, applied to CSF, although the phrasing is general)
Limit of Quantitation (Sensitivity)	Consistent with clinical needs	10 mg/dL (Implied from general sensitivity statement, applied to CSF)

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

Sample Size: The document does not explicitly state the exact number of samples used for the method comparison study (the "test set"). It mentions "comparative performance studies" and "precision studies."
Data Provenance: The document does not specify the country of origin of the data. It implies the data was collected at Abbott Laboratories or a contract research organization working with them. It is a prospective study as it involves conducting new tests to compare the device against a predicate, rather than analyzing existing datasets.

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

This is an in vitro diagnostic (IVD) assay for quantitative protein measurement. The "ground truth" is established by the reference method (the predicate device) or by established analytical techniques. It doesn't involve human expert adjudication in the same way an imaging or pathology device would. Therefore, this question is not directly applicable in a conventional sense for this type of device. The "experts" would be the laboratory personnel performing the assays and analyzing the results according to validated laboratory practices.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an IVD assay where quantitative measurements from one device are compared against another, not a diagnostic interpretation requiring adjudication of reader opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or pathology system for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, in the context of an IVD, the "standalone" performance refers to the device's analytical performance on its own, which is what the linearity, precision, and sensitivity studies assessed. The method comparison also evaluates the device's performance against a predicate as a standalone system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance studies was:

Reference Method/Predicate Device: For method comparison, the Boehringer Mannheim® Urinary/CSF Protein assay on the Hitachi® 717 Analyzer served as the reference standard.
Known Concentrations: For linearity and sensitivity, materials with known concentrations (e.g., calibrators/standards) were used.
Control Materials: For precision studies, control materials with expected ranges were used.

8. The Sample Size for the Training Set

Not applicable in the typical sense of machine learning. This is a traditional in vitro diagnostic assay based on a turbidimetric chemical reaction. There isn't a "training set" of data for an algorithm as there would be for an AI/ML device. The "training" of the assay involves optimization of the reagent formulation and reaction conditions, which is a chemical and engineering process, not a data-driven algorithm training.

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

Not applicable. As mentioned, there isn't a "training set" in the AI/ML context. The optimization of the assay's chemical parameters (reagent formulation, reaction conditions) would be based on fundamental chemical principles and empirical experimentation to achieve desired analytical performance characteristics. The "ground truth" for this optimization would be accurate measurements from established analytical methods during development to ensure the new reagent performs as expected.

Summary

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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 510(k) September 29, 1998 MicroproteinFinal3.lwp

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:

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981295

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.