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510(k) Data Aggregation
(150 days)
The CEDIA Buprenorphine II Assay is a homogeneous enzyme immunoassay for the qualitative and/or semiquantitative determination for the presence of buprenorphine and its metabolites in human urine at a cut-off concentration of 10 ng/ mL. The assay is intended to be used in laboratories and provides a simple and rapid analytical screening procedure to detect buprenorphine and its metabolites in human urine. The assay is designed for use with a number of clinical chemistry analyzers.
The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid chromatography/tandem mass spectrometry (LC-MS/ MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
CEDIA Buprenorphine II Calibrators:
The CEDIA Buprenorphine II calibrators and CEDIA Negative Calibrator II are intended for the calibration of the CEDIA Buprenorphine II Assay in human urine. For In Vitro Diagnostic Use Only.
CEDIA Buprenorphine II Control Set:
The CEDIA Buprenorphine II controls are used to validate the CEDIA Buprenorphine II Assay calibration in human urine. For In Vitro Diagnostic Use Only.
The assay consists of buffers (1 and 2) and lyophilized reagents (1a and 2a). The components include mouse monoclonal anti-buprenorphine antibody, recombinant microbial "enzyme donor'' - buprenorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives. Calibrators and controls are sold separately.
Here's a breakdown of the acceptance criteria and study information for the CEDIA Buprenorphine II Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance (CEDIA Buprenorphine II Assay) |
|---|---|---|
| Precision (Qualitative Mode) | -100% to -25% spiked samples: 100% Negative | -100% to -25% spiked samples: 100% Negative (80/80) |
| +25% to +100% spiked samples: 100% Positive | +25% to +100% spiked samples: 100% Positive (80/80) | |
| At 100% cutoff (10 ng/mL): Mix of Negative/Positive results expected around cutoff | At 100% cutoff (10 ng/mL): 27 Negative / 53 Positive (80 determinations) | |
| Precision (Semi-Quantitative Mode) | -100% to -25% spiked samples: 100% Negative | -100% to -25% spiked samples: 100% Negative (80/80) |
| +25% to +100% spiked samples: 100% Positive | +25% to +100% spiked samples: 100% Positive (80/80) | |
| At 100% cutoff (10 ng/mL): Mix of Negative/Positive results expected around cutoff | At 100% cutoff (10 ng/mL): 35 Negative / 45 Positive (80 determinations) | |
| Spike Recovery (Semi-Quantitative) | Spiked 7.5 ng/mL sample: Negative | 100% (20/20) Negative |
| Spiked 12.5 ng/mL sample: Positive | 100% (20/20) Positive | |
| Recovery within 80-120% of nominal values | Achieved for spiked samples | |
| Analytical Recovery and Dilution Linearity | (Implicit: Acceptable linearity and recovery across range for accurate quantification) | Refer to table for specific levels; e.g., 5 ng/mL - 119.8%, 100 ng/mL - 104.7% |
| Method Comparison and Accuracy (Qualitative) | (Implicit: High agreement with LC-MS/MS, especially outside near-cutoff zones) | High agreement in "Negative" (<50% cutoff) and "High Positives" (>50% cutoff) categories. Discordant samples detailed. |
| Method Comparison and Accuracy (Semi-Quantitative) | (Implicit: High agreement with LC-MS/MS, especially outside near-cutoff zones) | High agreement in "Negative" (<50% cutoff) and "High Positives" (>50% cutoff) categories. Discordant samples detailed. |
| Specificity (Cross-reactivity with Buprenorphine metabolites) | (Implicit: Detect target analytes effectively) | Buprenorphine, Norbuprenorphine, Norbuprenorphine-ß-D-glucuronide: ≥ 100% cross-reactivity. Buprenorphine-ß-D-glucuronide: 76.9% cross-reactivity. |
| Specificity (Cross-reactivity with other compounds) | (Implicit: Negligible cross-reactivity with structurally related/unrelated opiates and other commonly co-administered drugs) | Negligible cross-reactivity (< 0.01% - < 0.1%) for all tested compounds at high concentrations (e.g., 100,000 ng/mL, 500,000 ng/mL) |
| Interference (pH and Endogenous Substances) | (Implicit: No significant interference with assay results) | Low and High controls detected accurately across various pH levels and in presence of numerous endogenous substances (e.g., Acetone, Creatinine, Glucose, Hemoglobin) |
| Interference (Specific Gravity) | (Implicit: No significant interference with assay results) | Low and High controls detected accurately across specific gravity range of 1.000 to 1.030 |
| Open Vial Stability | (Implicit: Maintain performance for claimed duration) | Supports 60 days at 2-8°C for qualitative and semi-quantitative modes |
| Reagent On-Board Stability | (Implicit: Maintain performance for claimed duration) | Supports 60 days on-board clinical analyzer for qualitative and semi-quantitative modes |
| Reconstituted Reagent Stability | (Implicit: Maintain performance for claimed duration) | Supports 60 days at 2-8°C for qualitative and semi-quantitative modes |
| Real Time Stability | (Implicit: Demonstrate long-term stability) | Ongoing, carried out for up to six months. |
| Accelerated Stability (Reagents, Calibrators, Controls) | (Implicit: Predict long-term stability based on accelerated conditions) | Low and High Controls detected as Negative/Positive respectively for 6 months at 23±2°C (equivalent to 19 months based on 010 math model); recoveries within 80-120%. |
2. Sample Sizes and Data Provenance:
- Precision Study: n=80 (80 determinations for each spiked concentration)
- Analytical Recovery and Dilution Linearity: 10 intermediate levels, each run in replicates of five.
- Method Comparison and Accuracy: 153 urine patient samples.
- Specificity (Cross-reactivity): Known amounts of analytes added to drug-free urine.
- Interference (pH and Endogenous Substances): Known compounds of potentially interfering substances spiked into controls.
- Interference (Specific Gravity): Drug-free urine samples with specific gravity ranging from 1.000 to 1.030, spiked with controls.
- Stability Studies: Two lots for open vial, on-board, and reconstituted reagent stability. Three lots for real-time and accelerated stability.
Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be retrospective as it uses "urine patient samples" and "drug-free urine," implying previously collected samples, but it doesn't definitively state whether they were specifically collected for this study (prospective) or were pre-existing (retrospective). Given the context of 510(k) submissions, retrospective data is common for analytical validation using clinical specimens.
3. Number of Experts and their Qualifications for Ground Truth:
- Method Comparison and Accuracy: The ground truth for the 153 urine patient samples was established using LC-MS/MS (Liquid chromatography/tandem mass spectrometry).
- Number of Experts/Qualifications: The document does not specify the number of experts or their qualifications for interpreting the LC-MS/MS results. LC-MS/MS is a highly precise analytical method, and its results are generally considered the "gold standard" or definitive ground truth in toxicology. The interpretation of these results is typically performed by trained laboratory personnel.
4. Adjudication Method:
- Not applicable as the ground truth is established by a definitive analytical method (LC-MS/MS), not by expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic assay (laboratory test), not an imaging AI or diagnostic support system where human readers interpret results. The performance is evaluated analytically against a gold standard method.
6. Standalone (Algorithm Only) Performance:
- Yes, the study primarily describes standalone performance. The "Immunoassay Results" (both qualitative and semi-quantitative) are compared directly against the LC-MS/MS ground truth. There is no human-in-the-loop performance described. The device, an enzyme immunoassay, operates as a standalone analytical system.
7. Type of Ground Truth Used:
- The primary ground truth used for performance validation is definitive analytical method results, specifically LC-MS/MS (Liquid chromatography/tandem mass spectrometry), which is considered highly accurate for drug quantification in urine.
8. Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set. This is typical for a 510(k) submission for an IVD device like this, as the validation data presented ("Summary of Supporting Data") focuses on the final product's performance against a test set, rather than the development or training of the assay itself. The assay's development likely involved iterative testing and optimization, but specific training set sizes are not disclosed here.
9. How the Ground Truth for the Training Set was Established:
- As the training set information is not provided, the method for establishing its ground truth is also not described in this document.
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