The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Unine Protein Calibrator, is intended for the quantitative determination of transferin in urine by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of transferrin in human urine samples.

AI/ML Overview

Analysis of IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent

This document describes the performance of the IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent, a device intended for the quantitative determination of transferrin in human urine samples. The submission focuses on demonstrating substantial equivalence to a predicate device, the Beckman Transferrin Kit (Urine application) K926272.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" with numerical thresholds for all performance metrics. Instead, it presents performance data and implies acceptance based on substantial equivalence to the predicate device. For the purpose of this analysis, we will infer the acceptance criteria from the context of demonstrating equivalence and the reported values themselves.

Performance Metric	Implied Acceptance Criteria (Based on Equivalence)	Reported Device Performance (IMMAGE TRU Reagent)
Method Comparison	Demonstrated correlation and agreement with the predicate Beckman Transferrin Kit Reagent. (Specific correlation coefficients or bias not explicitly stated as criteria, but implied to be acceptable for equivalence).	Not explicitly quantified in this section; states "Equivalence is demonstrated through method comparison... that relate results obtained from the Beckman Transferrin Kit Reagent to the IMMAGE TRU Reagent."
Shelf-life Stability	Maintain performance specifications for claimed shelf-life.	24 month shelf-life
Open Container Stability	Maintain performance specifications for claimed open container stability.	14 day open container stability
Calibration Stability	Maintain performance specifications for claimed calibration stability.	14 day calibration stability
Within-Run Imprecision (Level 1)	Low Coefficient of Variation (CV)	Mean: 0.38 mg/dL; SD: 0.010 mg/dL; %CV: 2.7% (N=80)
Within-Run Imprecision (Level 2)	Low Coefficient of Variation (CV)	Mean: 1.55 mg/dL; SD: 0.041 mg/dL; %CV: 2.6% (N=80)
Within-Run Imprecision (Level 3)	Low Coefficient of Variation (CV)	Mean: 3.02 mg/dL; SD: 0.077 mg/dL; %CV: 2.6% (N=80)

Note on Method Comparison: The document states "Equivalence is demonstrated through method comparison," but does not provide specific data such as correlation coefficients (e.g., R-squared), slope, intercept, or bias information for the method comparison study in the provided text. This information would typically be present in a full submission to quantitatively demonstrate equivalence. The fragmented table under "Method Comparison Study Results" is unreadable and does not provide useful data.

2. Sample Size for the Test Set and Data Provenance

Method Comparison Study: The sample size for the method comparison study is not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.
Imprecision Study: The sample size for the imprecision study is 80 results for each of the three levels tested. The data provenance is not provided. It is typically conducted as a prospective study in a controlled laboratory setting.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

This device is an in vitro diagnostic (IVD) for quantitative determination of a biomarker, not an imaging or diagnostic AI device that requires expert interpretation for defining "ground truth." Therefore, the concept of "experts" establishing a disease diagnosis or image annotation ground truth is not applicable to this type of device.

For IVDs:

The "ground truth" for method comparison is the result obtained from the predicate device (Beckman Transferrin Kit Reagent).
The "ground truth" for imprecision and stability studies is the expected value or the reference method value for control materials.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (e.g., 2+1, 3+1) is typically associated with studies where multiple human readers independently interpret data (e.g., medical images) and their disagreements need to be resolved to establish a consensus ground truth.

Since this is an IVD device for quantitative measurement, and not an interpretative AI system, no adjudication method as described is applicable or mentioned. The performance is assessed against instrumental measurements and established reference methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation to assess if the AI improves human performance. As the IMMAGE TRU Reagent is a standalone IVD for quantitative measurement, it is not designed to assist human readers in an interpretative task, and therefore, an MRMC study is not applicable.

6. Standalone Performance Study

Yes, a standalone performance study was done for the IMMAGE TRU Reagent. The summaries of performance data (method comparison, stability, and imprecision experiments) represent the performance of the IMMAGE TRU Reagent itself (algorithm only, in the context of an automated analyzer) without a human-in-the-loop for result generation. The device is designed to provide quantitative results directly.

7. Type of Ground Truth Used

Method Comparison: The ground truth for the method comparison study was established by the predicate device, the Beckman Transferrin Kit (Urine application). Results from the IMMAGE TRU Reagent were compared to those obtained from the predicate to demonstrate substantial equivalence.
Stability and Imprecision: The ground truth for these studies would typically involve the use of certified reference materials or quality control materials with known target values. The reported mean values (e.g., 0.38 mg/dL, 1.55 mg/dL, 3.02 mg/dL) for the imprecision study represent the measured concentration in these materials.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this traditional immunochemistry reagent. This device is not an AI/machine learning algorithm that requires a training set to "learn" patterns or parameters. Its performance is based on the chemical and immunological principles of rate nephelometry and the characteristics of the reagents.

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

As noted above, there is no training set for this type of device. Thus, the method for establishing its ground truth is not applicable. The device's operational parameters and performance characteristics are determined by its design, manufacturing processes, and validation against a predicate device and established analytical standards.

Summary

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BECKMAN

K963976

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent

MAR 1 9 1997

Submitted By: 1.0

Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457

Date Submitted: 2.0

30 September 1996

3.0 Device Name(s):

3.1 Proprietary Name

IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent

3.2 Classification Name

Transferrin Test System (21 CFR § 866.5880)

Predicate Device(s): 4.0

Beckman Transferrin Kit (Urine application) K926272

5.0 Description:

6.0 Intended Use:

Beckman Instruments, Inc.

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Urine Transferrin (TRU) Reagent Summary of Safety & Effectiveness

Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE SystemTRU Reagent	Analytic Range	Same asBeckman Transfermin Kitreagent
IMMAGE SystemTRU Reagent	Nephelometric methodology
IMMAGE SystemTRU Reagent	Antibody source (goat)
DIFFERENCES
IMMAGE SystemTRU Reagent	Antigen excess testing	IMMAGE TRU has antigenexcess testing solutionincluded in the reagentcartridge, while the BeckmanTransfermin Kit requires off-linepreparation of the solution.
IMMAGE SystemTRU Reagent	Antibody concentration	IMMAGE TRU has a higherantibody concentration thanthe Beckman Transfermin Kit

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8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that relate results obtained from the Beckman Transferrin Kit Reagent to the IMMAGE TRU Reagent.

Method Comparison Study Results IMMAGE TRU Reagent vs. Beckman Transferrin Kit Reagent

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Stability Study Results

Reagent	Product Claim
IMMAGE TRU	24 month shelf-life14 day open container stability14 day calibration stability

Estimated Within-Run Imprecision

MATERIAL	MEAN (mg/dL)	SD (mg/dL)	%CV	Number of Results
TRU Reagent
Level 1	0.38	0.010	2.7	80
Level 2	1.55	0.041	2.6	80
Level 3	3.02	0.077	2.6	80

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).