The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.

Device Description

The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent, in coniunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for accuracy, stability, or precision. Instead, it presents performance data and implies that these results demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are inferred as aligning with the predicate's performance and generally accepted good laboratory practices for these types of assays.

Performance Metric	Implied Acceptance Criteria (Inferred from Predicate Equivalence & Good Practices)	Reported Device Performance
Method Comparison (Accuracy vs. Predicate)	High correlation (r close to 1), slope close to 1, intercept close to 0.	Slope: 0.992 Intercept: -0.307 r (correlation): 0.985
Stability (Shelf-life)	Maintenance of performance over the claimed shelf-life.	24 month shelf-life 14 day open container stability 14 day calibration stability
Precision (Within-Run)	Low %CV (coefficient of variation) indicating consistent results within a single run.	Level 1 (16.4 mg/dL): 1.8% CV Level 2 (25.5 mg/dL): 2.0% CV Level 3 (44.7 mg/dL): 1.6% CV
Precision (Total)	Low %CV across multiple runs/days, indicating overall reproducibility.	Level 1 (16.4 mg/dL): 2.0% CV Level 2 (25.5 mg/dL): 2.3% CV Level 3 (44.7 mg/dL): 1.8% CV

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

Sample Size (Method Comparison): 124 (samples)
Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The samples were "Serum."

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

This information is not provided in the document. For an immunochemistry system like this, the "ground truth" for method comparison is typically established by measurements from a reference method or a predicate device. There isn't typically "expert adjudication" in the same way there would be for image-based diagnostics.

4. Adjudication Method for the Test Set:

Not applicable in the traditional sense for this type of device. The "ground truth" for comparison is the result obtained from the Beckman Immunochemistry System PAB Prealbumin Reagent (on ARRAY® System), which is the predicate device. Therefore, no expert adjudication process (like 2+1 or 3+1) is mentioned or implied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is an immunochemistry assay, not an image-based diagnostic that involves human readers.

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

Yes, implicitly. The device (IMMAGE Immunochemistry System Prealbumin Reagent) is an automated system for quantitative determination. Its performance is measured directly against a predicate device and through stability and precision studies. There is no "human-in-the-loop" component in the operation or interpretation of the numerical results from this system.

7. The Type of Ground Truth Used:

Method Comparison: The "ground truth" was established by measurements obtained from the predicate device, specifically the "Beckman Prealbumin Reagent (PAB) on the ARRAY® Systems." This is a comparative measurement against an already marketed and accepted device.
Stability/Precision: The ground truth for these studies is the inherent performance of the device under controlled conditions, demonstrating reproducible and stable results. This is established through internal testing protocols.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This is a reagent and assay system, not a machine learning or AI model that requires a distinct "training set." The development of the assay itself involves optimization and validation, but not in the sense of training a discrete algorithmic model with a specific dataset.

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

Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this type of device. The development and validation of the reagent and assay involve standard laboratory procedures and chemical/biological principles.

Summary

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

K964781
MAY 9, 1997

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent

Submitted By: 1.0

Frank Marte, R.A.C. Sr. Regulatory Affairs Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea. California 92822-8000 Telephone: (714) 961-4406 FAX: (714) 961-4457

2.0 Date Submitted:

22 November 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent

3.2 Classification Names

Prealbumin immunological test system (21 CFR 866.5060)

4.0 Predicate Device(s):

Beckman Immunochemistry Systems PAB Prealbumin Reagent

5.0 Description:

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6.0 Intended Use:

Companson 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
IMMAGESystem (PAB)Reagent	Assay method - rate nephelometry ✓Serum:Analytic Range: 7.0 - 50 mg/dL ✓Extended Range: 1.17 - 1800 mg/dLSample and reagent ratios ✓Antibody source (goat) ✓Shelf life of 24 months ✓(stored at 2 -8°C)	Same as Beckman'sImmunochemistry SystemPrealbumin PAB Reagentas run on the ARRAY®System
DIFFERENCES
IMMAGESystem (PAB)Reagent	Reaction Temperature	IMMAGE System PABassays run at 37°C andthe predicate runs at26.7°C
	Buffer/Reagent Volume	IMMAGE System PABReagent uses one halfthe volume utilized by theArray System for the PABassay

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

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness The bata in the fromantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate mother obtained from the Beckman Immunochemistry System PAB Prealburnin (on ARRAY) Reagent to the IMMAGE System PAB Reagent.

Method Comparison Study Results IMMAGE PAB Reagent vs. Beckman Prealbumin Reagent (PAB) on ARRAY

Analyte	Sample Type	Slope	Intercept	r	n	Predicate
IMMAGEPAB	Serum	0.992	-0.307	0.985	124	BeckmanPrealbuminReagent (PAB)on theARRAY®Systems

Stability Study Results

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

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Beckman Instruments, Inc., Section 510(k) Notification Beckman Instruments, mistry System Prealbumin (PAB) Reagent Summary of Safety & Effectiveness

Precision Study Results IMMAGE PAB Reagent

MaterialSerum	Mean(mg/dL)	SD ( )	%CV	N
Within Run Precision
Level 1	16.4	0.29	1.8	80
Level 2	25.5	0.51	2.0	80
Level 3	44.7	0.72	1.6	80
Total Precision
Level 1	16.4	0.33	2.0	80
Level 2	25.5	0.59	2.3	80
Level 3	44.7	0.81	1.8	80

This summary of safety and effectiveness is being submitted in This Sammary - of - Carolyements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92

Regulation Number and Section

§ 866.5060 Prealbumin immunological test system.

(a)
Identification. A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.