(144 days)
No
The document describes a standard immunochemistry system and reagents for quantitative determination of drug concentrations using rate nephelometric inhibition immunoassay, with no mention of AI or ML.
No
Explanation: The device is intended for the quantitative determination of drug concentrations in human serum and plasma samples, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative determination of drug concentrations (carbamazepine, phenobarbital, phenytoin, and theophylline) in human serum and plasma samples, which is a common function of diagnostic devices for monitoring drug levels for patient care.
No
The device description explicitly states it includes "Reagents" and "Drug Calibrator 1," which are physical components, not software. It also refers to use on "Beckman's IMMAGE Immunochemistry System," which is a hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of specific drug concentrations (carbamazepine, phenobarbital, phenytoin, and theophylline) in human serum and plasma samples. This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples taken from the human body to provide information about a person's health status or drug levels.
- Device Description: The device description reiterates the intended use of determining drug concentrations in human serum and plasma samples.
- Methodology: The description mentions "rate nephelometric inhibition immunoassay," which is a laboratory technique used to measure substances in biological fluids.
- Performance Studies: The performance studies involve "method comparison" and "imprecision experiments" using human samples, further indicating its use in a laboratory setting for diagnostic purposes.
- Predicate Devices: The predicate devices listed are also IVD reagents (TDx Reagents), which supports the classification of this device as an IVD.
Therefore, based on the provided information, the JMMAGE Immunochemistry System (TDM) CAR. PHE. PHY. and THE Reagents and Beckman Drug Calibrator 1 are intended for use as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Abbott TDx Reagents to the IMMAGE System Reagents.
Method Comparison Study Results:
- Carbamazepine: Slope 0.982, Intercept 0.17, r 0.992, n 111, Predicate Method Abbott TDx Carbamazepine
- Phenobarbital: Slope 0.998, Intercept -1.18, r 0.996, n 103, Predicate Method Abbott TDx Phenobarbital II
- Phenytoin: Slope 1.051, Intercept -0.76, r 0.996, n 107, Predicate Method Abbott TDx Phenytoin
- Theophylline: Slope 0.992, Intercept 0.12, r 0.995, n 144, Predicate Method Abbott TDx Theophylline II
Stability Study Results:
- IMMAGE CAR, PHE, PHY, and THE: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
BECKMAN
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 System
Reagent | Predicate | Manufacturer | Docket
Number |
|--------------------------------|---------------------------------|-------------------------------|------------------|
| Carbamazepine (CAR)
Reagent | TDx®** Carbamazepine
Reagent | Abbott* Laboratories,
Inc. | K904226 |
| Phenobarbital (PHE)
Reagent | TDx Phenobarbital II
Reagent | Abbott Laboratories,
Inc. | K904226 |
| Phenytoin (PHY)
Reagent | TDx Phenytoin
Reagent | Abbott Laboratories,
Inc. | K904226 |
| Theophylline (THE)
Reagent | TDx Theophylline II
Reagent | Abbott Laboratories,
Inc. | K922991 |
*Abbott Laboratories, Abbott Park, IL 60064
** Trademark of Abbott Laboratories
Beckman Instruments, Inc.
1
5.0 Description:
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.
6.0 Intended Use:
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.
2
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 TDx |
| Reagents | ||
| Liquid stable reagents. | ||
| Initial analytic ranges. | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| (CAR, PHE, PHY, | ||
| THE) Reagents | IMMAGE utilizes nephelometric | |
| inhibition immunoassay | Abbott TDx reagents utilize | |
| fluorescence polarization | ||
| immunoassay | ||
| IMMAGE System | ||
| (CAR, PHE, PHY) | ||
| Reagents | Antibody source for IMMAGE CAR, | |
| PHE, and PHY reagents is mouse. | Antisera source for TDx | |
| Carbamazepine, Phenytoin, | ||
| and Phenobarbital is sheep. |
3
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 TDx |
| Carbamazepine | |||||
| Phenobarbital | 0.998 | -1.18 | 0.996 | 103 | Abbott TDx |
| Phenobarbital II | |||||
| Phenytoin | 1.051 | -0.76 | 0.996 | 107 | Abbott TDx |
| Phenytoin | |||||
| Theophylline | 0.992 | 0.12 | 0.995 | 144 | Abbott TDx |
| Theophylline 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-life |
| 14 day open container stability | |
| 14 day calibration stability |
4
4
Estimated Within-Run Imprecision
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