The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plaama samples by turbidimetric immunossay. This assay is designed for use with the IMMAGE Immunochemistry System.

Device Description

The IMMAGE System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of digoxin concentrations in human serum and plasma semples.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance metric in a standardized table. However, it implicitly defines acceptable performance by comparing the IMMAGE DIG Reagent to the predicate device, Abbott TDx Digoxin II Reagent, and by presenting its own performance characteristics. I will infer the implied acceptance criteria based on these comparisons and performance data.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (IMMAGE DIG Reagent)
Intended Use	Quantitative determination of digoxin in human serum and plasma.	Same as predicate (Abbott TDx Digoxin II Reagent).
Measurement Temperature	37°C	Same as predicate (Abbott TDx Digoxin II Reagent).
Sample Type	Human plasma and serum samples.	Same as predicate (Abbott TDx Digoxin II Reagent).
Analytic Range	0.2 to 5 ng/mL.	Same as predicate (Abbott TDx Digoxin II Reagent).
Assay Technology	Must be suitable for digoxin determination.	Turbidimetric inhibition immunoassay technology. (Different from predicate's fluorescence polarization immunoassay, but acceptable as demonstrated by method comparison).
Sample Pretreatment	Must be efficient for clinical use.	Does not require sample pretreatment. (Improved over predicate, which requires pretreatment).
Method Comparison	Substantial equivalence to predicate.	Regression Analysis (IMMAGE DIG vs. Abbott Digoxin II): Slope = 1.011 + 0.037, Intercept = 0.047 + 0.0016. (Indicates strong agreement and substantial equivalence to the predicate).
Shelf-Life Stability	Sufficient for clinical and commercial use.	18 months shelf-life.
On-Board Stability	Sufficient for clinical use.	14-day on-board stability.
Calibrator Shelf-Life	Sufficient for clinical and commercial use.	24 months shelf-life (Drug Calibrator 2).
Calibrator On-Board Stability	Sufficient for clinical use.	14-day calibration stability (Drug Calibrator 2).
Within-Run Imprecision	Low variability for accurate results.	Level 1 (Mean 0.87 U/mL): SD 0.042, %CV 4.8. Level 1 (Mean 1.32 U/mL): SD 0.068, %CV 5.1. Level 2 (Mean 2.63 U/mL): SD 0.079, %CV 3.0. Level 3 (Mean 4.19 U/mL): SD 0.095, %CV 2.3. (All reported %CVs are low, indicating good precision).

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

Test Set Size: The document does not explicitly state the total number of samples or patients used for the "Method Comparison Study." However, it mentions "Number of Results" for Imprecision studies:
- Level 1 (0.87 U/mL): 15 results
- Level 1 (1.32 U/mL): 80 results
- Level 2 (2.63 U/mL): 80 results
- Level 3 (4.19 U/mL): 80 results
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable to this type of device and study. The IMMAGE DIG Reagent is an in-vitro diagnostic (IVD) device for quantitative biochemical measurement. Its ground truth is established through comparison to a recognized predicate device (Abbott TDx Digoxin II Reagent), which itself is validated against established analytical methods, and through its own analytical performance (imprecision, stability). There are no "experts" in the human diagnostic interpretation sense establishing a "ground truth" for each sample.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this is an IVD device measuring a biochemical analyte. Adjudication methods like 2+1 or 3+1 are typically used in imaging or clinical diagnostic studies where human interpretation of medical data is involved. The "ground truth" for the test set is based on the quantitative results from the predicate device (Abbott Digoxin II) and the analytical characteristics of the IMMAGE DIG Reagent itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. MRMC studies are relevant for devices where human readers interpret data, such as in medical imaging. This device is an automated immunoassay system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this is essentially a standalone performance study. The IMMAGE Immunochemistry System Digoxin (DIG) Reagent is an automated in-vitro diagnostic test. Its performance data (method comparison, stability, imprecision) represent its direct analytical capability without direct human intervention in the result generation or interpretation workflow that would be considered "human-in-the-loop" for an AI device. The system provides a quantitative measurement.

7. The Type of Ground Truth Used

The ground truth for validating the IMMAGE DIG Reagent's performance in the method comparison study was the results obtained from the predicate device, Abbott TDx Digoxin II Reagent.
For the stability and imprecision studies, the ground truth is based on the inherent analytical properties and precision of the IMMAGE system itself and reference materials/controls.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an in-vitro diagnostic reagent and system, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system would involve optimizing chemical formulations and system parameters during development, not learning from a labeled dataset.

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

Not applicable. As explained in point 8, there isn't a "training set" or "ground truth" as typically defined for AI/ML models. The development process would involve optimizing reagents and instrument settings to achieve desired analytical performance characteristics.

Summary

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200 South Kraemer Boulevard, Box 8000, Brea, CA 92622-8000 • (714) 993-5321

BECKMAN

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent

Sybmitted By: 1.0

K96 3062

Sheri Hall Manager, Premarket Regulatory Margie George Project Manager, Systems Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92622-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759

DEC 13 1996

2.0 Date Submitted:

04 Decamber 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Digoxin Reagent Beckman Drug Calibrator 2

3.2 Classification Names

Digoxin immunological test system (21 CFR 866.5775) Clinical toxicology calibrator (21 CFR 862.3200)

4.0 Predicate Device(s):

Behring Diagnostics N Latex RF. K942328 Abbott TDx Digoxin II Reagent, K882233

5.0 Description:

6.0 Intended Use:

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. '

Comparison to Prodicate(s): 7.0

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

Reagent	Specific Characteristics	Comments
DIG Reagent	Intended use for themeasurement of digoxin at 37°C	Same as TDxDigoxin II Reagent
	Reagent measures digoxin inboth human plasma and serumsamples	Same as TDxDigoxin II Reagent
	Analytic Range of 0.2 to 5ng/mL	Same as TDxDigoxin II Reagent
DIG Reagent	Assay Type	IMMAGE System DIG Reagent usesturbidimetric inhibition immunoassaytechnology while the predicate usesfluorescence polarizationimmunoassay technology
	Sample Pretreatment	IMMAGE System DIG Reagent doesnot require sample pretreatmentwhile the predicate requires samplepretreatment

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 Abbott Digoxin II Reagent to the IMMAGE DIG Reagent.

Method Comparison Study Results® IMMAGE DiG Reagent vs. Abbott Digoxin II Reagent

		MARKET STATE STATE CONTRACT COLLECTION CONTROLLERS CARAL CARADHAN CARADHING CONTROLLER		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IMMAGEDIG	1.011 + 0.037	0.047 + 0.0016	DISTE	001 DXDigoxin
.

· Deming regression analysis

Stability Study Results

ababa ( bone angena 1 ( 1 ( 1 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 =
IMMAGE DIG	18 months shelf-life14-day on board
Drug Calibrator 2	24 months sholf-life14-day calibration

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Estimated Within-Run Improcision

	MEAN (U/mL)	SD (U/mL)	MCV	Number of Results
Level 1	0.87	0.042	4.8	15
Level 1	1.32	0.068	5.1	80
Level 2	2.63	0.079	3.0	80
Level 3	4.19	0.095	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.

Regulation Number and Section

§ 862.3320 Digoxin test system.

(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.