The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro quantities of micro albumin in in human urine samples on Beckman's IMMAGE™ Immunochemistry System.

AI/ML Overview

Here's an analysis of the provided text regarding the Beckman IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent, structured according to your request:

In this case, the "device" is the IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent, an in-vitro diagnostic test. The acceptance criteria for such devices typically revolve around analytical performance metrics that demonstrate its ability to accurately and reliably measure the intended analyte compared to a predicate device.

Acceptance Criteria and Reported Device Performance for IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. However, based on the studies performed, the implicit acceptance criteria are that the IMMAGE MA Reagent demonstrates:

Substantial Equivalence: Performance comparable to the predicate device (Beckman MA Microalbumin Reagent Kit).
Analytical Performance: Acceptable linearity (demonstrated by method comparison), precision (imprecision study), and stability (shelf-life and open container stability).

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Method Comparison	Substantial equivalence to predicate (Beckman MA Reagent Kit), indicated by high correlation (r), slope close to 1, and intercept close to 0.	Slope: 0.957Intercept: -0.03Correlation (r): 0.991(Compared against Beckman MA Reagent on Array® 360 System)
Total Imprecision	Acceptable variability at different analyte levels.	Level 1 (0.56 mg/dL): S.D. 0.055 mg/dL, %C.V. 9.8%Level 2 (2.25 mg/dL): S.D. 0.121 mg/dL, %C.V. 5.4%Level 3 (3.19 mg/dL): S.D. 0.073 mg/dL, %C.V. 2.3%
Within-Run Imprecision	Acceptable variability within a single run.	Level 1 (0.56 mg/dL): S.D. 0.042 mg/dL, %C.V. 7.5%Level 2 (2.25 mg/dL): S.D. 0.107 mg/dL, %C.V. 4.7%Level 3 (3.19 mg/dL): S.D. 0.063 mg/dL, %C.V. 2.0%
Shelf-life Stability	Functional and accurate for a specified period.	6 month shelf-life
Open Container Stability	Functional and accurate for a specified period after opening.	14 day open container stability
Calibration Stability	Calibration remains valid for a specified period.	7 day calibration stability

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

Method Comparison:
- Sample Size: n = 109 urine samples.
- Data Provenance: Not explicitly stated, but clinical samples are implied as "urine samples." The country of origin and whether they were retrospective or prospective is not specified in this summary.
Imprecision Study:
- Sample Size: n = 80 measurements for each of the three levels (total 240 measurements for each imprecision type). These are likely replicates of control or spiked samples, not individual patient samples.
- Data Provenance: Not specified, but standard laboratory controls or prepared samples would be used.

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

Not applicable for this type of in-vitro diagnostic device. The "ground truth" for analytical performance studies is established by a reference method (the predicate device in this case) or by careful preparation of known concentration standards. Expert interpretation of results is not typically the primary ground truth for an analytical performance claim.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for subjective interpretations (e.g., imaging studies) where multiple human readers are involved. For quantitative analytical tests like this, the 'ground truth' is a numerical value from a reference method or known standard, not a consensus interpretation.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, not an AI-powered image analysis tool or decision support system that would involve human readers.

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

Yes, the studies presented (method comparison, stability, imprecision) demonstrate the standalone performance of the IMMAGE MA Reagent on the IMMAGE Immunochemistry System. This is an "algorithm only" type of test in the sense that the instrument's measurement algorithm processes the chemical reaction data to produce a quantitative result without direct human interpretation of the measurement itself (beyond operating the instrument and interpreting the final numerical value).

7. The Type of Ground Truth Used

For Method Comparison: The ground truth was established by comparing the IMMAGE MA Reagent to the Beckman MA Reagent on the Array® 360 System (the predicate method). This is a reference method comparison.
For Imprecision Studies: The ground truth for the mean values was established by known concentrations of control or spiked samples (Level 1, Level 2, Level 3).

8. The Sample Size for the Training Set

Not explicitly stated or applicable in the traditional sense of machine learning. This is an analytical chemistry reagent, not a machine learning algorithm that requires a "training set" of data to learn patterns. The "training" for such a system would involve validating its chemical components and instrument parameters during development, but this is not typically referred to as a "training set" in regulatory submissions for these types of devices. If any 'training' data was used, it would be for internal development and optimization of the reagent and instrument parameters, not disclosed as a specific "training set" in a 510(k) summary.

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

As explained above, the concept of a "training set" with established ground truth in the context of machine learning does not directly apply here. For the development and optimization of the reagent and instrument, the ground truth would have been established through:

Known concentrations: Prepared solutions of microalbumin at precise concentrations.
Reference materials: Certified reference materials for albumin.
Historical data: Performance relative to established analytical methods during development.

Summary

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BECKMAN

K965035

1997

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent

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

2.0 Date Submitted:

16 December 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent

3.2 Classification Name

Albumin immunological test system (21 CFR § 866.5040)

Predicate Device(s): 4.0

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemMicroalbumin (MA)Reagent	Beckman MAMicroalbumin ReagentKit	Beckman Instruments,Inc.	K895883

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

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

5.0 Description:

The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro albumin in in human urine samples on Beckman's IMMAGE™ quantities of Immunochemistry System.

6.0 Intended Use:

The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in
conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.

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 SystemMA Reagent	Analytic Range	Same as BeckmanMicroalbumin Reagent Kit
	Nephelometric methodology
	Antibody source (goat)
DIFFERENCES
IMMAGE SystemMA Reagent	Antigen excess testing solution	IMMAGE MA has antigenexcess testing solutionincluded in the reagentcartridge, while the BeckmanMicroalbumin Reagent Kitrequires off-line preparation ofthe solution.
	Antibody concentration	IMMAGE MA has a higherantibody concentration thanthe Beckman MicroalbuminReagent Kit

file: ma510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification Bockman munochemistry System Microalbumin (MA) Reagent Summary of Safety & Effectiveness

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Substantial Squivalence to Shornethod Companson, 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 Microalbumin (MA) Reagent

Analyte	Sample Type	Slope	Intercept	r	n	Predicate Method
IMMAGEMAReagent	urine	0.957	-0.03	0.991	109	BeckmanMA Reagent

Stability Study Results

ALLE ARREAL CONTRACTOR COLLECTION CONTRACT CONTROLLERS CONTROLLERS CONTROLLED CONSULTER CONTROLLERS CONTRACTOR CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACTComments of the contract and the contract and the contraction of the comments of the comments of the comments of the comments of the comments of the comments of the commentsBEATH THE STATE FOR A FRANCE FOR A F E COLLECT COOCLE EXCELLAND FILG A COLLECTeagent	Productional
IMMAGE MA	month shelf-life
	14 day open container stability
	day calibration stability

Estimated Imprecision

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.56	0.042	7.5	80
Level 2	2.25	0.107	4.7	80
Level 3	3.19	0.063	2.0	80
Total Imprecision
Level 1	0.56	0.055	9.8	80
Level 2	2.25	0.121	5.4	80
Level 3	3.19	0.073	2.3	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.

file: ma510k.sse

Regulation Number and Section

§ 862.1645 Urinary protein or albumin (nonquantitative) test system.

(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) 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.(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 § 862.9.