(203 days)
The Abbott Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
The Carbamazepine Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Carbamazepine Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests.
Here is a summary of the acceptance criteria and the study details for the Abbott Carbamazepine Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Sensitivity (LOQ) | Lowest concentration with inter-assay precision CV at ≤ 7% | 1.9 µg/mL (Meets design acceptance criteria) |
| Precision | Total run %CV ≤ 6.3% | Total run %CV ≤ 6.3% (Meets design acceptance criteria) |
| Spike Recovery | Recovery within ±10% or ±0.4 µg/mL error of HPLC results | All samples recovered within ±10% or ±0.4 µg/mL error of the HPLC results. |
| Method Comparison (vs. HPLC) | Good correlation expected | Relationship: y = 1.093x + 0.372, R = 0.9584 (n=105) - "correlated well" |
| Method Comparison (vs. Predicate) | Good correlation with Abbott Aeroset Carbamazepine Assay (K993028) expected | Relationship: y = 0.905x + 0.564, R = 0.9675 (n=103) - "correlated well" |
| Matrix Comparison | Confirmation of suitability for various matrices | Suitable for use in: serum (glass/plastic), SST (plastic), plasma with sodium fluoride/potassium oxalate (plastic), plasma with sodium heparin (plastic/glass), plasma with lithium heparin (plastic with/without gel), plasma with K3 EDTA (glass/plastic), plasma with K2 EDTA (plastic), and sodium citrate (plastic/glass). |
| Specificity | Minimal to no cross-reactivity to other medications; minimal to no interference from endogenous substances | Showed minimal to no cross-reactivity to other medications. Showed minimal to no interference to endogenous substances up to tested concentrations. |
| Linearity | Linear performance throughout the assay range | Performs in a linear fashion from 0.5 to 20 µg/mL. |
| Onboard Stability | Stable for a specified period on the ARCHITECT cSystem | Reagents stable onboard for up to 45 days. |
| Standard Curve Calibration Stability | Stable for a specified period on the ARCHITECT cSystem | Standard curve calibration stable for up to 7 days. |
| Reagent Shelf Life Stability | Stable for a specified period at 2-8°C | Reagents stable at 2-8°C for 24 months. |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Method Comparison (vs. HPLC): 105 samples
- Sample Size for Method Comparison (vs. Predicate): 103 samples
- Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin of the data. The context of a 510(k) submission for an in vitro diagnostic usually implies controlled laboratory studies.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- This device is an in vitro diagnostic assay, where "ground truth" is typically established by reference methods or instruments rather than expert human interpretation of images/cases.
- For the method comparison studies, the "ground truth" was established by comparing the device's results to:
- HPLC (High-Performance Liquid Chromatography): This is a gold standard analytical chemistry technique for quantifying carbamazepine. The document does not specify human experts or their qualifications for interpreting HPLC results; the HPLC itself serves as the reference.
- Abbott Aeroset® Carbamazepine Assay (K993028): This is the legally marketed predicate device, used as a comparative reference.
4. Adjudication Method for the Test Set
- Not applicable. As described above, "ground truth" for this type of device is established by instrumental reference methods (HPLC) or comparison to a predicate device, rather than human adjudication of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human readers in making diagnostic interpretations. The Abbott Carbamazepine Assay is an in vitro diagnostic for quantitative measurement of a drug in bodily fluids and does not involve human readers interpreting "cases" in the same way.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance assessment was conducted. The "device performance" metrics listed in the summary (Functional Sensitivity, Precision, Spike Recovery, Method Comparison, Linearity, Stability, etc.) directly reflect the performance of the assay system (reagents plus ARCHITECT cSystems instrument) without human-in-the-loop interpretation. The device's output is a quantitative measurement, not an interpretation requiring human assistance.
7. Type of Ground Truth Used
- The ground truth primarily used for evaluating the device's performance was:
- Reference method data (HPLC): For accuracy and recovery studies.
- Predicate device data (Abbott Aeroset® Carbamazepine Assay): For method comparison to demonstrate substantial equivalence.
- Internal analytical standards and controls: For precision, linearity, and stability studies.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" sample size. For an in vitro diagnostic assay, development typically involves extensive characterization and optimization of reagents and assay parameters rather than training a machine learning algorithm with a distinct dataset. The "development" or "optimization" samples are integral to method formulation, but aren't typically referred to as a "training set" in the context of device submission for this type of product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not explicitly described as a "training set" with established ground truth in the traditional sense. For IVD assays, the process involves calibrating the assay using known concentrations of the analyte (carbamazepine calibrators) that serve as a reference for quantifying unknown samples. These calibrators and controls have precisely defined concentrations, which act as the "ground truth" for establishing the assay's curve and performance characteristics during development and ongoing use. The development process itself ensures the assay yields accurate results against these known standards.
§ 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.