The IMMAGE Immunochemistry System Alpha-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha-antitrypsin by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System AAT Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of alpha-antitrypsin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.

AI/ML Overview

The provided text describes the Summary of Safety & Effectiveness for the BECKMAN IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent. This document is a 510(k) Notification, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through a clinical trial with acceptance criteria.

Therefore, the information you've requested regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not typically found in this type of submission for this kind of device (a laboratory reagent for an existing immunochemistry system). This document focuses on demonstrating that the new reagent performs similarly to an already approved predicate device.

However, I can extract the performance data that is provided to show how the device's performance was characterized.

Here's a breakdown of the available information:

Description of the Study and Device Performance

The study presented here is a demonstration of substantial equivalence for a new reagent (IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent) compared to a predicate device (Beckman Alpha₁-Antitrypsin (AAT) Reagent) on an existing immunochemistry system. The core of the study involves method comparison, stability, and imprecision experiments. These experiments aim to show that the new IMMAGE system reagent performs comparably to the predicate reagent when both are used on their respective systems (IMMAGE vs. Array® 360).

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" in the sense of a clinical trial's pre-defined thresholds for metrics like sensitivity, specificity, or AUC are not provided. This is a 510(k) for a reagent, and the goal is to show equivalence to a predicate. The performance data focuses on precision and stability.

Performance Metric	Reported Device Performance (IMMAGE AAT Reagent)
Method Comparison	Data provided in a tabular format, but the specific statistical results (e.g., correlation coefficient, accuracy at different levels) for the comparison between IMMAGE System AAT and Beckman Array® Systems AAT are unreadable due to OCR issues in the provided text snippet. The document states, "Equivalence is demonstrated through method comparison... experiments that results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent."
Stability	"14 day open container stability" is mentioned in comments, implying evaluation of the reagent's stability after opening. No specific quantitative criteria or results are readable.
Imprecision (Total)	High Serum Levels
	- Level 1 (Mean 70.1 mg/dL): SD = 2.33 mg/dL, %CV = 3.3
	- Level 2 (Mean 296 mg/dL): SD = 8.2 mg/dL, %CV = 2.8
	- Level 3 (Mean 509 mg/dL): SD = 16.4 mg/dL, %CV = 3.2
	Low Serum Levels
	- Level 1 (Mean 10.9 mg/dL): SD = 0.40 mg/dL, %CV = 3.7
	- Level 2 (Mean 44.3 mg/dL): SD = 0.73 mg/dL, %CV = 1.6
Imprecision (Within Run)	High Serum Levels
	- Level 1 (Mean 70.1 mg/dL): SD = 1.87 mg/dL, %CV = 2.7
	- Level 2 (Mean 296 mg/dL): SD = 6.2 mg/dL, %CV = 2.1
	- Level 3 (Mean 509 mg/dL): SD = 15.9 mg/dL, %CV = 3.1
	Low Serum Levels
	- Level 1 (Mean 10.9 mg/dL): SD = 0.36 mg/dL, %CV = 3.3
	- Level 2 (Mean 44.3 mg/dL): SD = 0.72 mg/dL, %CV = 1.6

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

Imprecision Study Test Set Sample Size:
- High Serum Levels: 80 data points for each of the three serum levels for both Within Run and Total Imprecision.
- Low Serum Levels: 30 data points for each of the two serum levels for both Within Run and Total Imprecision.
Method Comparison Study Test Set Sample Size: Not explicitly stated or readable in the provided snippet.
Data Provenance: Not specified (e.g., country of origin). The study appears to be an internal validation by the manufacturer, Beckman Instruments, Inc. It is likely prospective, as it involves testing the new reagent.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this submission. For a diagnostic reagent for quantitative measurement of a biomarker, "ground truth" is typically established by the inherent accuracy and reference methods of the predicate device and the analytical chemistry principles involved, rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This is not applicable as there is no "adjudication" of expert opinions for a quantitative laboratory reagent.

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

No, an MRMC study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human readers in interpretation. This document pertains to a laboratory reagent.

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

This is not applicable. The device is a reagent for an automated immunochemistry system, not a standalone AI algorithm. The performance described is the "standalone" performance of the reagent on the instrument.

7. The Type of Ground Truth Used

The "ground truth" for this device is effectively the quantitative concentration of alpha-antitrypsin in serum. This is established through the analytical precision and accuracy of the measurement system, benchmarked against the predicate device which has been previously deemed safe and effective. It's based on analytical measurement/biochemical principles rather than subjective interpretation, pathology, or outcomes data in the typical sense of a clinical trial for an AI or imaging device.

8. The Sample Size for the Training Set

This is not applicable. The device is a reagent, not an AI algorithm that requires a training set in the machine learning sense. The "development" of the IMMAGE AAT reagent would have involved chemical formulation and optimization, not algorithmic training on a dataset.

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

This is not applicable for the reasons stated above.

Summary

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BECKMAN

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Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent

APR

1.0 Submitted By:

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

26 November 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent

3.2 Classification Name

Alpha-1-antitrypsin immunological test system. (21 CFR § 866.5130)

4.0 Predicate Device(s):

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemAlpha₁-Antitrypsin (AAT)	Beckman Alpha₁-Antitrypsin (AAT)	Beckman Instruments,Inc.	K771603

5.0 Description:

Beckman Instruments, Inc.

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent Summary of Safety & Effectiveness

6.0 Intended Use:

7.0 Comparison to Predicate(s):

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

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE SystemAAT Reagent	Analytic Range	Same as BeckmanAlpha₁-Antitrypsin reagent
	Nephelometric methodology
	Antibody source (goat)
DIFFERENCES
IMMAGE SystemAAT Reagent	Buffer/Reagent volumes	IMMAGE System uses half ofthe volumes than are utilizedby the Array System for AAT.
	Antibody concentration	IMMAGE AAT has a higherantibody concentration thanthe Beckman Alpha₁-Antitrypsin reagent

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 comparison, stability, and imprecision experiments that results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

Method Comparison Study Results IMMAGE Alpha -- Antitrypsin (AAT) Reagent

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha--Antitrypsin (AAT) Reagent Summary of Safety & Effectiveness

Stability Study Results

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	14 day open container stability
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TYPE OF PRECISION	SAMPLE	Data Points	Test Mean Value (mg/dL)	SD (mg/dL)	% CV
Within Run	Serum Level 1	80	70.1	1.87	2.7
	Serum Level 2	80	296	6.2	2.1
	Serum Level 3	80	509	15.9	3.1
Total	Serum Level 1	80	70.1	2.33	3.3
	Serum Level 2	80	296	8.2	2.8
	Serum Level 3	80	509	16.4	3.2

Estimated Imprecision .

TYPEOFPRECISION	SAMPLE	DataPoints*	TestMeanValue(mg/dL)	SD(mg/dL)	% CV
Within Run	Low Serum Level 1	30	10.9	0.36	3.3
	Low Serum Level 2	30	44.3	0.72	1.6
Total	Low Serum Level 1	30	10.9	0.40	3.7
	Low Serum Level 2	30	44.3	0.73	1.6

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.

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Regulation Number and Section

§ 866.5130

Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).