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510(k) Data Aggregation
(144 days)
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
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.
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.
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.
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