The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.

Device Description

The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 analytes per sample. Major hardware components include a reagent compartment, and reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies.

AI/ML Overview

Acceptance Criteria and Study for IMMAGE™ Immunochemistry System

This report summarizes the acceptance criteria and the study that demonstrates the IMMAGE™ Immunochemistry System meets these criteria, based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IMMAGE™ Immunochemistry System are implicitly defined by its ability to demonstrate "Substantial Equivalence" to existing predicate devices. This equivalence is primarily shown through method comparison and imprecision studies. While explicit numerical acceptance criteria for slope, intercept, correlation coefficient (r), and %CV are not stated in the document as pre-defined "acceptance criteria," the reported performance values are presented to demonstrate substantial equivalence. Therefore, the reported performance metrics can be considered as the evidence meeting the underlying requirement for substantial equivalence.

Table 1: Acceptance Criteria (Implicit) and Reported Device Performance

Performance Metric	Implicit Acceptance Criteria (Demonstrates Substantial Equivalence)	Reported Device Performance	Comments
Method Comparison			Determined by comparing the IMMAGE System to predicate devices. Strong correlation and slopes/intercepts close to 1 and 0, respectively, indicate substantial equivalence.
Slope	Close to 1.0 (indicating proportional agreement with predicate)	0.9789 - 1.1108 (Range across analytes)	All slopes are close to 1.0, demonstrating proportional agreement.
Intercept	Close to 0.0 (indicating no significant constant bias)	-10.06 - 8.05 (Range across analytes)	Most intercepts are close to 0, indicating minimal constant bias. Transferrin/serum has the largest negative intercept, while Complement C3 has the largest positive.
Correlation Coefficient (r)	High (e.g., >0.95, indicating strong linear relationship)	0.940 - 0.998 (Range across analytes)	All 'r' values are high, indicating a strong linear relationship with the predicate methods. The lowest 'r' is for Rheumatoid Factor (0.940), which is still generally considered a strong correlation in these types of studies.
Within-run Imprecision (%CV)	Low (indicating good precision and reproducibility)	1.1% - 7.2% (Range across analytes and levels)	All %CVs are relatively low, demonstrating good within-run precision for all tested analytes across different concentration levels. The highest %CV is Digoxin, Level 2 (7.2%).

2. Sample Size and Data Provenance

Test Set Sample Size: For the estimated within-run imprecision study, a sample size of N=80 measurements was used for each analyte at each of three different levels (e.g., Apolipoprotein A Level 1, Level 2, Level 3 each had N=80). The text does not explicitly state the sample size for the method comparison study (slope, intercept, r).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission in the US (Beckman Instruments, Inc., Brea, California), it is highly probable the studies were conducted in the US, likely within a laboratory setting. The nature of these studies (method comparison and imprecision) typically involves prospective collection of samples for dedicated analytical runs.

3. Number and Qualifications of Experts for Ground Truth

This type of device (an immunochemistry analyzer) does not typically rely on human expert consensus for "ground truth" in the same way an imaging AI device would. The "ground truth" for the test results is established by the performance of the predicate devices themselves, which are already cleared for clinical use and whose accuracy is accepted. The "experts" implied here would be clinical laboratory professionals following standard testing protocols. No specific number or qualifications of experts are mentioned for establishing the ground truth, as it's defined by the established analytical methods of the predicate devices.

4. Adjudication Method

Not applicable for this type of device performance study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish a gold standard, such as in diagnostic imaging. For quantitative analytical devices, the "truth" is determined by the reference measurement method (predicate device) and analytical precision.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. MRMC studies are primarily relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists, pathologists) and where the AI assists or replaces that interpretation. The IMMAGE™ Immunochemistry System is an automated analytical instrument; its performance is compared to other instruments, not human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Method Comparison Study Results" and "Estimated Within-run Imprecision" directly represent the standalone performance of the IMMAGE™ Immunochemistry System, demonstrating its analytical capabilities (accuracy relative to predicates and precision) without human intervention in the result generation or interpretation process beyond operating the instrument. The device itself provides quantitative measurements.

7. Type of Ground Truth Used

The type of ground truth used for the method comparison study is the results obtained from established predicate devices. For analytical precision, the ground truth is statistical measurements based on repeated analyses of control materials or patient samples, where the "true" value is an accepted reference or a statistically derived mean.

8. Sample Size for the Training Set

The document does not provide information on a "training set" or its sample size. This is because the IMMAGE™ Immunochemistry System is an analytical instrument, not a machine learning or AI algorithm in the contemporary sense that would require a distinct "training set" for model development. The data presented relates to the validation of the finalized system.

9. How Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no explicit mention of a "training set" in the context of this device's submission. The "ground truth" for device validation is based on comparison to predicate methods and established analytical principles.

Summary

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IMMAGE™ Immunochemistry System

1.0 Submitted Bv

K962294

Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd. W-337 Brea. California 92622-8000 Telephone: (714) 993-8916 FAX: (714) 961-4457

AUG 21 1996

2.0 Date Submitted

15 June 1996

3.0 Device Name(s)

3.1 Proprietary Names

IMMAGE™ Immunochemistry System

3.2 Classification Names

Nephelometer for clinical use (21 CFR 862.2700) Discrete photometric chemistry analyzer for clinical use (21 CFR 862.2160)

4.0 Predicate Device(s)

Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913. K926272. K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328)

5.0 Description

The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 Major hardware components include a reagent compartment, analytes per sample. and reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies.

6.0 Intended Use

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7.0 Comparison to Predicate(s)

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

Aspect/Characteristic	Comments
SIMILARITIES
Intended for: in vitro diagnostic quantitation ofcomponents of biological fluids by ratenephelometry and nephometric inhibition	same as ARRAY System
Measures nephelometric increase in light scatterdue to immunoprecipitin formation betweenantigen and antibody	same as ARRAY System
Uses nephelometric inhibition immunoassay tomeasure drugs and small molecular weightconstituents	same as ARRAY System
Uses non-linear math models to describe standardcurve determined during reagent manufacturingand a single point calibration for routine instrumentoperation	same as ARRAY System
Uses plastic reaction cuvettes which are washedbetween samples	same as ARRAY System
Measures turbidimetric decrease in transmittedlight due to immunoprecipitin formation betweenantigen and antibody where one is coupled to latexparticles	same as LPIA 100
Mathematically calculated absorbance units fromthe measured transmitted light intensity andcalculated rate of change of absorbance duringreaction	same as LPIA 100
Measures turbidimetric transmitted light scatter inthe forward direction (0°- 15°)	same as LPIA 100
Cuvette light path 7 mm and reaction incubationtemperature controlled at 37°C	same as LPIA 100
DIFFERENCES
IMMAGE System uses visible laser diode at 670nm as the light source for nephelometry	ARRAY System uses a tungstenhalogen lamp at 400-620
IMMAGE System detects light scatter at 90° fromthe incident beam angle	ARRAY System detects lightscatter at 70° angle
IMMAGE System maintains reaction temperatureat 37°C	ARRAY System maintainsreaction temperature at 26.7°C
IMMAGE System uses a LED at 940 nm as lightsource for turbidimetry	LPIA-100 uses a tungstenhalogen light source at 950 nm
IMMAGE uses non-linear math models to describestandard curves during reagent manufacture and asingle point calibration for routine instrumentoperation	LPIA-100 uses linear andquadratic math models with amultipoint calibration duringoperation
IMMAGE uses washable plastic reaction cuvettes	LPIA-100 uses disposableplastic reaction cuvettes

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Summary of Performance Data 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of The duta in the romance to in viro diagnostic test systems already in commercial Substantial Equivalence is demonstrated through method comparison and imprecision distribution: Equiraliencesults obtained from the IMMAGE Immunochemistry System to selected predicate methods.

Analyte	Slope	Intercept	r	Predicate
Apolipoprotein A	0.9958	1.78	0.985	ARRAY System
Complement C3	0.9789	8.05	0.990	ARRAY System
Digoxin	1.0637	-0.02	0.968	Abbott TDx*
Immunoglobulin A	1.0281	-4.61	0.995	ARRAY System
Rheumatoid Factor	1.0545	0.41	0.940	Behring N Latex RF
Theophylline	0.9917	0.12	0.955	Abbott TDx
Transferrin/serum	1.0316	-10.06	0.985	ARRAY System
Transferrin/urine	1.1108	-0.04	0.998	ARRAY System

Method Comparison Study Results IMMAGE Immunochemistry System vs Selected Predicate Methods

*TDx is a registered tradmark of Abbott Diagnostics

Estimated Within-run Imprecision

MATERIAL	MEAN	SD	%CV	N
Apolipoprotein A (mg/dL)
Level 1	56.0	1.92	3.4	80
Level 2	103	2.6	2.5	80
Level 3	163	2.5	1.5	80
Complement C3 (mg/dL)
Level 1	67.1	1.3	1.9	80
Level 2	102	2.2	2.1	80
Level 3	395	8.7	2.2	80
Digoxin (ng/mL)
Level 1	1.18	0.063	5.3	80
Level 2	2.47	0.177	7.2	80
Level 3	4.16	0.109	2.6	80

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Immunoglobulin A (mg/dL)
Level 1	123	2.1	1.7	80
Level 2	261	3.4	1.3	80
Level 3	599	19.2	3.2	80
Rheumatoid Factor (IU/mL)
Level 1	123	1.5	1.2	80
Level 2	290	3.1	1.1	80
Level 3	613	8.7	1.4	80
Theophylline (µg/mL)
Level 1	8.12	0.17	2.2	80
Level 2	19.9	0.30	1.5	80
Level 3	32.4	0.46	1.4	80
Transferrin/serum (mg/dL)
Level 1	241	6.8	2.8	80
Level 2	364	15.2	4.2	80
Level 3	680	17.9	2.6	80
Transferrin/urine (mg/dL)
Level 1	0.38	0.008	2.2	80
Level 2	1.56	0.042	2.7	80
Level 3	3.06	0.124	4.1	80

This summary of safety and effectiveness is being submitted in accordance with the This summary of safety and enectivelless is being Submitted in according regulation 21 CFR 807.92.

Regulation Number and Section

§ 862.2700 Nephelometer for clinical use.

(a)
Identification. A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.(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.