Search Results
Found 1 results
510(k) Data Aggregation
(25 days)
The modified Multi-Drug Specialty Control Set and the modified Specialty Control Set 1 are intended to be used as quality control material to monitor drugs of abuse assays.
The Multi-Drug Control Set and the Specialty Control Set 1 are manufactured using human urine, multiple drugs of abuse, stabilizers, and preservatives. The drugs are appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by CEDIA.
The provided text is a summary for a 510(k) premarket notification for two quality control devices, the Multi-Drug Control Set and the Specialty Control Set 1. Such summaries focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device.
Therefore, the document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study report would for a diagnostic or therapeutic device. Instead, it aims to show that the new devices are as safe and effective as already marketed predicate devices.
However, based on the information provided, we can infer some "performance characteristics" and "acceptance criteria" related to the substantial equivalence claim.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature (Implied Acceptance Criteria) | Device Performance (Reported) |
|---|---|
| For Multi-Drug Control Set (vs. MAS Liquid Urinalysis Controls): | |
| Same Matrix as Predicate | Yes, "Same matrix." |
| Same Composition as Predicate | Yes, "Same composition" |
| Same Manufacturer as Predicate | Yes, "Same manufacturer." (This refers to both devices being from Boehringer Mannheim, implying consistency in manufacturing processes as compared to the predicate, though the predicate itself is MAS) |
| Same Confirmatory Method as Predicate | Yes, "Same confirmatory method." |
| Same Open Vial Stability Claim as Predicate | Yes, "Same open vial stability claim." |
| Control Target Concentrations | See tables in the original document for detailed comparison. The values are similar but not identical for all analytes and levels, supporting the "modification" aspect. For example, MAS Liquid Urinalysis Controls have an additional "4" level for LSD, and some target concentrations vary slightly (e.g., Benzoylecgonine High: 375 ng/mL for modified Multi-Drug vs. 360 ng/mL for MAS). The claim is likely that the ranges or intended functionality remain equivalent despite slight numeric differences. |
| Intended Use | "Monitoring assays for drugs of abuse." (Modified Multi-Drug) vs. "Multi-analyte Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in a quantitative and qualitative analyses of patient urine specimens for drugs and drug metabolites." (MAS Liquid Urinalysis Controls). The intended uses are functionally very similar. |
| Dose Verification (Accuracy of Spike) | "Confirmation of target doses by GC/MS." (This is a performance characteristic, implying the spiked concentrations were verified to be correct). |
| Open Vial Stability | "Equivalent performance as the predicate device." (This confirms the claim above.) |
| For Specialty Control Set 1 (vs. Multi-Drug Control Set): | |
| Same Matrix as Predicate | Yes, "Same matrix." |
| Same Composition as Predicate | Yes, "Same composition" |
| Same Manufacturer as Predicate | Yes, "Same manufacturer." |
| Same Confirmatory Method as Predicate | Yes, "Same confirmatory method." |
| Same Open Vial Stability Claim as Predicate | Yes, "Same open vial stability claim." |
| Control Target Concentrations | See tables in the original document for detailed comparison. Concentrations differ as Specialty Control Set 1 is a different product with different target levels for the included drugs. For example, Benzoylecgonine Low is 112 ng/mL for Specialty Control Set 1 vs. 225 ng/mL for Multi-Drug Control Set. The claim is substantial equivalence despite different specific concentration targets as both serve as controls. |
| Intended Use | "Monitoring assays for drugs of abuse." (Modified Specialty Control Set 1) vs. "The Multi-Drug Control Set is used as unassayed control material with drugs of abuse assays for amphetamines, barbiturates, benzodiazepines, cocaine metabolite, methadone, methaqualone, opiates, phencyclidine, and propoxyphene." (Multi-Drug Control Set). Both essentially serve the same function of monitoring drugs of abuse assays. |
| Dose Verification (Accuracy of Spike) | "Confirmation of target doses by GC/MS." |
| Open Vial Stability | "Equivalent performance as the predicate device." |
2. Sample size used for the test set and the data provenance:
- The document does not specify a "test set" sample size in terms of number of controls or batches tested for the performance characteristics like "Dose verification" or "Open Vial Stability Study." These are generally internal validation studies, not large clinical trials.
- Data provenance (country of origin, retrospective/prospective) is not mentioned. These are quality control materials, so the provenance of the internal validation data is usually less emphasized than patient data for clinical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided in the context of this 510(k) summary. "Ground truth" in this context refers to the known concentrations of the spiked drugs. This is established chemically during manufacturing and verified by analytical methods like GC/MS, not by human experts interpreting results. The experts involved would be analytical chemists.
4. Adjudication method for the test set:
- Not applicable/provided. Adjudication methods are typically associated with human interpretation tasks or clinical endpoints, which is not the primary focus here. The "dose verification" would involve comparing instrumental measurements to expected values.
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 device is a quality control material for drug assays, not an AI-powered diagnostic or screening tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a reagent/control, not an algorithm.
7. The type of ground truth used:
- The ground truth for the performance characteristics (dose verification, stability) is the known, spiked concentration of each drug within the control material, analytically verified by methods such as GC/MS (Gas Chromatography/Mass Spectrometry). For QC materials, this is a chemical, not an observational, ground truth.
8. The sample size for the training set:
- Not applicable/provided. This device is a quality control material, not a machine learning algorithm that requires a "training set" in the conventional sense. The controls are manufactured to specific concentrations.
9. How the ground truth for the training set was established:
- Not applicable. As explained above, there is no "training set" for an algorithm. The "ground truth" (i.e., the correct concentration values) for the control materials themselves is established during manufacturing by precise spiking and then verified using analytical methods like GC/MS. The document states that the controls are "quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by CEDIA," confirming that the establishment of values is an analytical and calibration process.
Ask a specific question about this device
Page 1 of 1