The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" with specific thresholds for method comparison metrics (Slope, Intercept, r-value). However, the "Summary of Performance Data" presents the results of these studies, implying these values are deemed acceptable for demonstrating substantial equivalence. The predicate device's performance would serve as the implicit benchmark.

Since explicit acceptance criteria are not provided for the method comparison, I will present the reported performance as fulfilling the implied acceptance for substantial equivalence based on the comparison to the predicate.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Strong correlation (r-value close to 1) with predicate device.	r = 0.994
	Slope close to 1.	Slope = 0.954
	Intercept close to 0.	Intercept = 1.62
Stability	Meets specified shelf-life and open/calibration stability.	24 month shelf-life, 14 day open container stability, 14 day calibration stability
Within-Run Imprecision	Not explicitly stated, but expected to be low.	Data not clearly provided in the excerpt.

Note: The section for "Estimated Within-Run Imprecision" contains garbled text. Therefore, specific acceptance criteria and performance data for this metric cannot be extracted from the provided document.

Study Details

This submission describes the development of a reagent for use on an existing system (IMMAGE™ Immunochemistry System), not a standalone diagnostic device in the sense of an AI algorithm or imaging system. Therefore, some of the requested categories (like number of experts for ground truth, adjudication method, MRMC studies) are not applicable to this type of device and study.

1. Sample Sizes and Data Provenance:

Test Set Sample Size (Method Comparison): 141 samples
Data Provenance: Human serum samples. Country of origin not specified. The study appears to be prospective in nature, comparing the new reagent's performance against the existing predicate on new samples.

2. Number of Experts and Qualifications for Ground Truth:

Not Applicable. This is a quantitative chemical assay. The "ground truth" for the method comparison is the measurement obtained from the established predicate device (Beckman AAG Reagent on Array® 360). There are no "experts" in the sense of clinical decision-makers involved in establishing ground truth for individual samples in this context.

3. Adjudication Method for Test Set:

Not Applicable. As a quantitative assay comparison, there is no need for adjudication by experts. The comparison is between two quantitative measurements.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not applicable to a chemical assay reagent. MRMC studies are typically used for diagnostic imaging or other subjective interpretation tasks where human readers are involved.

5. Standalone Performance Study:

Yes, in essence. The "Method Comparison Study Results" section directly shows the performance of the IMMAGE AAG Reagent (the "algorithm/device" in this context) in generating quantitative results compared to an established method. This demonstrates the reagent's performance on its own, albeit in comparison to a predicate, not necessarily against a "true" gold standard across all possible ranges.

6. Type of Ground Truth Used:

Comparison to a Predicate Method. The "ground truth" for the method comparison study was the quantitative results obtained from the Beckman AAG Reagent on Array® 360, which is the well-established predicate device. This is a form of comparative truth rather than an absolute biological truth like pathology or outcomes data.

7. Sample Size for Training Set:

Not specified. The document does not mention a "training set" in the context of an algorithm. This is a chemical reagent, likely optimized through laboratory development and testing rather than machine learning training.

8. How Ground Truth for Training Set was Established:

Not Applicable. As there's no specified "training set" in the machine learning sense, this question is not relevant. The reagent development would have involved various analytical chemistry and formulation studies, but not "ground truth" establishment for training an algorithm.

Summary

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K966257

BECKMAN

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent

1.0 Submitted By:

MAR 2 4 1997

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

2.0 Date Submitted:

24 October 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent

3.2 Classification Name

Alpha-1-glycoproteins immunological test system (21 CFR § 866.5420)

4.0 Predicate Device(s):

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemAlpha₁-AcidGlycoprotein (AAG)	Beckman Alpha₁-AcidGlycoprotein Reagent	Beckman Instruments,Inc.	K791341

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

5.0 Description:

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 SystemAAG Reagent	Initial Analytic Range	Same asBeckman AAG Reagent
	Nephelometric methodology
	Antibody source (goat)
	DIFFERENCES
IMMAGE SystemAAG Reagent	Buffer/Reagent volumes	IMMAGE System uses half ofthe volumes than are utilizedby the Array System for AAG.
	Antibody concentration	IMMAGE AAG has a higherantibody concentration thanthe Beckman Alpha₁-AcidGlycoprotein reagent.

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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 comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents.

Method Comparison Study Results IMMAGE Alpha-1-Acid Glycoprotein (AAG) Reagent

Analyte	Sample Type	Slope	Intercept	r	n	Predicate Method
IMMAGEAAGReagent	serum	0.954	1.62	0.994	141	Beckman AAG Reagenton Array® 360

Stability Study Results

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

Estimated Within-Run Imprecision

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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

§ 866.5420

Alpha -1-glycoproteins immunological test system.(a)
Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.(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.