(79 days)
TDx® Carbamazepine Assay
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No
The device description and performance studies describe a standard immunoassay technology and do not mention any AI or ML components.
No
This device is for the quantitative determination of carbamazepine in serum or plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device quantifies carbamazepine levels in serum or plasma, which is a key function of a diagnostic device used to measure substances in the body for medical purposes.
No
The device description clearly outlines a competitive immunoassay using direct chemiluminescent technology with physical components like reagents, antibodies coupled to paramagnetic particles, and a system that detects relative light units (RLUs). This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of carbamazepine in serum or plasma". This indicates the device is used to analyze biological samples (serum or plasma) in vitro (outside the body).
- Device Description: The description details a "competitive immunoassay" that uses "patient sample" and "monoclonal mouse anti-carbamazepine antibody". This further confirms the analysis of biological samples using laboratory techniques.
- Performance Studies: The performance studies describe "Method Comparison" using "303 samples" and "Precision" using "Six samples". These are typical studies performed on devices designed to analyze biological samples.
- Key Metrics: The mention of "Sensitivity" and "Assay Reportable Range" are metrics relevant to the performance of a diagnostic test on biological samples.
- Predicate Device: The mention of a "Predicate Device" (TDx® Carbamazepine Assay) which is also an assay, strongly suggests this device is in the same category, which is IVD.
All these elements point to the device being used to perform a diagnostic test on biological samples in vitro, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
Product codes
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Device Description
Therapeutic drug monitoring of carbamazepine helps the physician to establish the therapeutic dose based on individual response to the drug, to adjust dosage to reduce adverse effects while controlling seizures, and to ensure patient compliance with the established regimen.
The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology. Carbamazepine in the patient sample competes with an acridinium ester-labeled carbamazepine derivative in the Lite Reagent for a limited amount of monoclonal mouse anti-carbamazepine antibody, which is coupled to paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of carbamazepine present in the patient sample and the amount of relative light units (RLUs) detected by the system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison: For 303 samples in the range of 0.87 to 14.06 ug/mL (3.68 to 59.47 umol/L), the relationship between the ACS:180 Carbamazepine assay and an alternate fluorescence polarization method is described by the equation: ACS:180 Carbamazepine = 1.01 (alternate method) + 0.71 ug/mL.
Precision: Six samples were assayed 6 times in 6 assays, on each of 4 systems (n = 144 for each sample), over a period of 3 days. Total precision (%CV) ranged from 5.4 to 6.70.
Key Metrics
Correlation coefficient (r) = 0.96
Sensitivity: The ACS:180 Carbamazepine assay measures carbamazepine concentrations to 20 ug/mL 84.6 umol/L) with a minimum detectable concentration of 0.2 ug/mL (0.8 umol/L). Sensitivity is defined as the concentration of carbamazepine that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 27 replicate determinations of the carbamazepine zero standard.
Assay Reportable Range: The ACS:180 Carbamazepine assay measures carbamazepine concentrations up to 20 ug/mL (84.6 umol/L) with a minimum detectable concentration of 0.2 µg/mL (0.8 umol/L).
Predicate Device(s)
TDx® Carbamazepine Assay.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
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- Submitters Information
FEB 1 4 1997
- Submitters Information
| Contact person: | William J. Pignato
Director of Regulatory Affairs |
|------------------------|-------------------------------------------------------------------------|
| Address: | Chiron Diagnostics Corporation
63 North Street
Medfield, MA 02052 |
| Phone: | 508 359-3825 |
| Date Summary Prepared: | November 22, 1996 |
2. Device Information
| Proprietary Name: | Chiron Diagnostics ACS:180 Carbamazepine Assay |
|---|---|
| Common Name: | Assay for Carbamazepine |
3. Predicate Device Information
| Name: | TDx® Carbamazepine Assay. |
|---|---|
| Manufacturer: | Abbott Laboratories |
4. Device Description
Therapeutic drug monitoring of carbamazepine helps the physician to establish the therapeutic dose based on individual response to the drug, to adjust dosage to reduce adverse effects while controlling seizures, and to ensure patient compliance with the established regimen.
The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology. Carbamazepine in the patient sample competes with an acridinium ester-labeled carbamazepine derivative in the Lite Reagent for a limited amount of monoclonal mouse anti-carbamazepine antibody, which is coupled to paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of carbamazepine present in the patient sample and the amount of relative light units (RLUs) detected by the system.
1
5. Statement of Intended Use
For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
6. Summary of Technological Characteristics
The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology.
7. Performance Characteristics
Expected Results
A therapeutic range of 4 to 10 µg/mL (16.9 to 42.3 µmoVL) has been previously reported for carbamazeoine. As with all therapeutic drug assays, each laboratory should determine the appropriateness of this range for the diagnostic evaluation of patient results.
Sensitivity
The ACS:180 Carbamazepine assay measures carbamazepine concentrations to 20 ug/mL 84.6 umol/L) with a minimum detectable concentration of 0.2 ug/mL (0.8 umol/L). Sensitivity is defined as the concentration of carbamazepine that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 27 replicate determinations of the carbamazepine zero standard.
Assay Reportable Range
The ACS:180 Carbamazepine assay measures carbamazepine concentrations up to 20 ug/mL (84.6 umol/L) with a minimum detectable concentration of 0.2 µg/mL (0.8 umol/L).
Method Comparison
For 303 samples in the range of 0.87 to 14.06 ug/mL (3.68 to 59.47 umol/L), the relationship between the ACS:180 Carbamazepine assay and an alternate fluorescence polarization method is described by the equation:
ACS:180 Carbamazepine = 1.01 (alternate method) + 0.71 ug/mL Correlation coefficient (r) = 0.96
2
Precision
Six samples were assayed 6 times in 6 assays, on each of 4 systems (n = 144 for each sample), over a period of 3 days. The following results were obtained:
Total precision (%CV) ranged from 5.4 to 6.70