The JMMAGE Immunochemistry System (TDM) CAR. PHE. PHY. and THE Reagents in conjunction with Beckman Drug Calibrator 1, are intended for use in the quantitative determination of carbamazepine. phenobarbital, phenytoin, and theophylline concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

The IMMAGE Immunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma bv rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenobarbital in human serum or plasma bv rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Phenytoin (PHY) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenytoin in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Theophylline (THE) reagent when, used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of theophylline in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE™ Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, and Theophylline test systems.

Device Description

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Device: IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents [Carbamazepine (CAR), Phenobarbital (PHE), Phenytoin (PHY), and Theophylline (THE)]

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in this document are primarily related to method comparison (correlation with a predicate device), stability, and imprecision. However, explicit numerical acceptance criteria are not stated; instead, the reported performance is presented, demonstrating equivalence to already marketed devices.

Analyte	Acceptance Criteria (Implicit)	Reported Device Performance (Slope)	Reported Device Performance (Intercept)	Reported Device Performance (r-value)	Reported Device Performance (n, samples)
Carbamazepine	Substantial equivalence to predicate	0.982	0.17	0.992	111
Phenobarbital	Substantial equivalence to predicate	0.998	-1.18	0.996	103
Phenytoin	Substantial equivalence to predicate	1.051	-0.76	0.996	107
Theophylline	Substantial equivalence to predicate	0.992	0.12	0.995	144

Reagent	Acceptance Criteria (Implicit)	Reported Device Performance
IMMAGE CAR, PHE, PHY, and THE	Substantial equivalence to predicate, demonstrating claimed stability	24 month shelf-life
IMMAGE CAR, PHE, PHY, and THE	Substantial equivalence to predicate, demonstrating claimed stability	14 day open container stability
IMMAGE CAR, PHE, PHY, and THE	Substantial equivalence to predicate, demonstrating claimed stability	14 day calibration stability

Note: The document only provides "Estimated Within-Run Imprecision" without specific numerical values, making it impossible to directly compare to acceptance criteria in a table format. It states generally: "These reagents exhibit acceptable imprecision for the intended use."

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

Sample Size (Method Comparison - Test Set):
- Carbamazepine (CAR): 111 samples
- Phenobarbital (PHE): 103 samples
- Phenytoin (PHY): 107 samples
- Theophylline (THE): 144 samples
Data Provenance: Not specified. It is likely internal data generated by Beckman Instruments, Inc. The document does not mention external sources or specific geographic locations for the samples.
Retrospective or Prospective: Not specified. Standard practice for method comparison studies like these would typically involve prospective testing of patient samples against the predicate method, but this is not explicitly stated.

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

Not applicable. This is a diagnostic device for quantitative determination of drug concentrations, not an AI or imaging device requiring human expert consensus for ground truth. The "ground truth" for the method comparison study is established by the results from the predicate device (Abbott TDx reagents).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI or imaging device requiring human adjudication. The comparison is directly between the new device's measurements and the predicate device's measurements.

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

Not applicable. This is not an AI device or an imaging device involving human readers.

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

The studies described are standalone performance studies. The IMMAGE™ Immunochemistry System, including these reagents, performs the quantitative determination of drug concentrations without human-in-the-loop interaction for result generation. The performance data presented (method comparison, stability, imprecision) reflects the device's intrinsic analytical capabilities.

7. The Type of Ground Truth Used

The ground truth for the method comparison studies was established by the predicate device's measurements. For example, for Carbamazepine, the Abbott TDx Carbamazepine reagent was used as the reference method.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI-based system that requires a "training set." It is a chemical immunoassay system where reagents react to determine concentrations.

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

Not applicable, as there is no training set for this type of device.

Summary

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BECKMAN

K963673

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents [Carbamazepine (CAR), Phenobarbital (PHE), Phenytoin (PHY), and Theophylline (THE)]

FEB - 4 1997

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:

12 September 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Carbamazepine (CAR) Reagent IMMAGE™ Immunochemistry System Phenobarbital (PHE) Reagent IMMAGE™ Immunochemistry System Phenytoin (PHY) Reagent IMMAGE™ Immunochemistry System Theophylline (THE) Reagent IMMAGE™ Immunochemistry Systems Drug Calibrator 1

3.2 Classification Names

Carbamazepine Test System (Not Classified) Phenobarbital Test System (21 CFR §862.3660) Phenytoin Test System (Not Classified) Theophylline Test System (21 CFR §862.3880) Calibrator (21 CFR §862.1150)

Predicate Device(s): 4.0

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
Carbamazepine (CAR)Reagent	TDx®** CarbamazepineReagent	Abbott* Laboratories,Inc.	K904226
Phenobarbital (PHE)Reagent	TDx Phenobarbital IIReagent	Abbott Laboratories,Inc.	K904226
Phenytoin (PHY)Reagent	TDx PhenytoinReagent	Abbott Laboratories,Inc.	K904226
Theophylline (THE)Reagent	TDx Theophylline IIReagent	Abbott Laboratories,Inc.	K922991

*Abbott Laboratories, Abbott Park, IL 60064

** Trademark of Abbott Laboratories

Beckman Instruments, Inc.

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5.0 Description:

6.0 Intended Use:

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Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System TDM (CAR, PHE, PHY, & THE) Reagents Summary of Safety & Effectiveness

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 System(CAR, PHE, PHY,THE) Reagents	Intended use.	Same as Abbott TDxReagents
	Liquid stable reagents.
	Initial analytic ranges.
DIFFERENCES
IMMAGE System(CAR, PHE, PHY,THE) Reagents	IMMAGE utilizes nephelometricinhibition immunoassay	Abbott TDx reagents utilizefluorescence polarizationimmunoassay
IMMAGE System(CAR, PHE, PHY)Reagents	Antibody source for IMMAGE CAR,PHE, and PHY reagents is mouse.	Antisera source for TDxCarbamazepine, Phenytoin,and Phenobarbital is sheep.

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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 companson, stability, and imprecision experiments that relate results obtained from the Abbott TDx Reagents to the IMMAGE System Reagents.

Analyte	Slope	Intercept	r	n	Predicate Method
Carbamazepine	0.982	0.17	0.992	111	Abbott TDxCarbamazepine
Phenobarbital	0.998	-1.18	0.996	103	Abbott TDxPhenobarbital II
Phenytoin	1.051	-0.76	0.996	107	Abbott TDxPhenytoin
Theophylline	0.992	0.12	0.995	144	Abbott TDxTheophylline II

Method Comparison* Study Results IMMAGE System CAR. PHE. PHY, and THE Reagents

Deming Regression statistics used

Stability Study Results

Reagent	Product Claim
IMMAGE CAR, PHE, PHY, and THE	24 month shelf-life14 day open container stability14 day calibration stability

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Estimated Within-Run Imprecision

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The Comments of Children of Children

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

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.