Search Results
Found 1 results
510(k) Data Aggregation
(55 days)
The PCP Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
The Urine Phencyclidine (PCP) Screen Flex® reagent cartridge is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of phencyclidine in human urine.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Urine Phencyclidine (PCP) Screen Flex® reagent cartridge, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds. However, we can infer the performance metrics evaluated and their reported outcomes:
| Performance Metric | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (Agreement with Predicate) | High percentage agreement with the predicate device (Abbott AxSYM® System Phencyclidine II Assay) at the 25 ng/mL cutoff. | 98% agreement with the predicate method. |
| Qualitative Analysis (Agreement with GC/MS for Discordant Samples) | Discordant samples should have GC/MS values that explain the discrepancy. | 5 discordant samples (positive by PCP method, negative by AxSYM) had GC/MS values of 24, 20, 25, 19, 44 ng/mL. |
| Qualitative Spiked Sample Recovery (Negatives) | Samples spiked at <= 25% of the cutoff (0-18.75 ng/mL) should be consistently negative. | Consistently distinguished as negative. |
| Qualitative Spiked Sample Recovery (Positives) | Samples spiked at >= 25% of the cutoff (31.25-1000 ng/mL) should be consistently positive. | Consistently distinguished as positive. |
| Semiquantitative Spiked Sample Recovery | Quantitated values should be within 10% of the nominal concentration. | Quantitated within 10% of the nominal concentration between 8 and 75 ng/mL. |
| Semiquantitative Precision (Within-run %CV) | Acceptable within-run precision for controls and cutoff concentrations. Specific threshold not given, but industry standards for immunoassays typically aim for low CVs (e.g., <10%). | 2.1 to 5.0% for controls and cutoff concentrations. |
| Semiquantitative Precision (Total %CV) | Acceptable total precision for controls and cutoff concentrations. Specific threshold not given. | 5.5 to 6.5% for controls and cutoff concentrations. |
| Correlation with GC/MS (Semiquantitative) | Good relationship between semiquantitative readings and GC/MS values. | "The comparative analyses demonstrated a good relationship between the semiquantitative analyses and GC/MS values." (No specific correlation coefficient provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Qualitative Comparative Analysis (PCP vs. AxSYM): 213 specimens.
- GC/MS Confirmation (Diconcordant & Selected): 42 samples (all positive by PCP method and a portion of negative samples).
- Spiked Sample Recovery: Not explicitly stated, but performed at various known concentrations.
- Precision Study: Not explicitly stated, but performed at the 25 ng/mL cutoff level and controls at +/- 25% of the cutoff.
- Data Provenance: The document does not specify the country of origin. It appears to be retrospective, utilizing pre-collected specimens for the comparative analysis and GC/MS confirmation, and laboratory-prepared spiked samples for recovery and precision.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth was established by laboratory reference methods (GC/MS) or by the performance of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of expert review. Ground truth was established by a reference method (GC/MS) or comparison to a predicate device. For the comparative analysis, any discrepancies between the test device and the predicate were further investigated by GC/MS.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay, not an imaging-based or clinical decision support AI system where human reader performance would be directly evaluated. Its performance is assessed against analytical methods and predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this entire study represents a standalone performance evaluation. The "Urine Phencyclidine (PCP) Screen Flex® reagent cartridge" on the "Dimension® clinical chemistry system" operates as an automated assay. The results are generated by the device, and its performance is assessed analytically (precision, accuracy against known standards, agreement with predicate/GC/MS), without human interpretation as part of the primary diagnostic output.
7. The Type of Ground Truth Used
- For Qualitative Analysis (Comparative): The predicate device (Abbott AxSYM® System Phencyclidine II Assay) served as an initial "ground truth" for comparison, with Gas Chromatography/Mass Spectrometry (GC/MS) used as the definitive confirmatory ground truth for discordant samples and a portion of positive/negative samples.
- For Spiked Sample Recovery: Known concentrations of phencyclidine in spiked samples.
- For Precision: Known concentrations of controls and cutoff-level samples.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" because this device is a reagent cartridge for an enzyme immunoassay, not a machine learning or AI model that typically requires a distinct training phase. Its performance is intrinsically linked to the chemical reactions and optical detection system designed within the assay.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no explicitly defined "training set" in the context of this traditional immunoassay device. The assay's "design" or "calibration" (analogous to training in ML) would have been established through internal R&D processes using purified analytes and characterized matrices, but this is not detailed in the 510(k) summary.
Ask a specific question about this device
Page 1 of 1