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510(k) Data Aggregation
(392 days)
QuickScreen™ Amphetamine 500 Test Model 9058 (dip card): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen™ Amphetamine 500 Test Model 9054 (cassette): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen ™ Multi Drug Screening Test Model 9346T(dip card): The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinquish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen™ Drug Cup Model 9346Z: The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't typically contain detailed "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it presents performance data to show the new device performs similarly to the predicate device and is safe and effective for its intended use. The "acceptance criteria" can be inferred from the reported performance meeting the generally understood expectations for such devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that explicit formal acceptance criteria are not stated in the document, I will infer them based on the context of drug screening tests and the data presented. The primary acceptance criteria for a qualitative drug screening test revolve around its ability to accurately identify positive and negative samples relative to a confirmatory method, especially around the cutoff concentration.
Device: QuickScreen Drug Screening Test System (specifically for Amphetamine 500 ng/ml cutoff)
| Performance Metric (Inferred Acceptance Criterion) | Reported Device Performance (Amphetamine 500 ng/ml) |
|---|---|
| Sensitivity / Precision (Qualitative Agreement around Cutoff): Accurately identify negative samples below cutoff. Accurately identify positive samples above cutoff. | Negative samples: All samples at 100.86 ng/ml, 211.2 ng/ml, 286.22 ng/ml tested negative (60/60 for multi-card, cassette, cup; 80/80 for dipcard at 100.86 ng/ml; 60/60 for dipcard at other concentrations). Positive samples: All samples at 583.3 ng/ml, 878 ng/ml, 1062 ng/ml, 1361 ng/ml tested positive (60/60 for all formats and concentrations). |
| Method Comparison (Clinical Sample Agreement with GC/MS): High concordance with GC/MS for both positive and negative samples, particularly near the cutoff. Minimize false positives and false negatives. | Overall Agreement: For samples above cutoff, the device correctly identified all as positive (22 samples in "Cutoff to +50%" and 20 in "High Positive" categories for all formats). For samples below cutoff, the device correctly identified all as negative (23 samples in "Negative: NO DRUG" and 19 in "Negative < -50% of cutoff" categories for all formats). Discordant Results: 4 samples (421.6 ng/ml, 440.2 ng/ml, 450.1 ng/ml, 454.6 ng/ml) with GC/MS values below the 500 ng/ml cutoff were reported as Positive by the device. These fall within the "Negative -50% to Cutoff" GC/MS range (250 ng/ml to 500 ng/ml). While technically "false positives" relative to the cutoff, these are expected for screening devices and are often described as "cross-cutoff" detections, indicating sensitivity. All these were within 50 ng/ml (~10%) of the cutoff concentration. |
| Cross-reactivity: Limited cross-reactivity with structurally related compounds at physiologically relevant concentrations. No significant interference from unrelated compounds. | Structurally Related: L-amphetamine: 5.0% cross-reactivity at 10,000 ng/ml. MDA: 50% cross-reactivity at 1000 ng/ml. MDMA: 0% cross-reactivity at 100,000 ng/ml. Unrelated Compounds: No interference observed up to 100 µg/ml. |
| Sample pH Effects: Performance should be stable across typical urine pH ranges. | No effect observed from pH 4.5 to 8.5 for samples at 250, 375, 625, and 750 ng/ml. |
| Specific Gravity Effects: Performance should be stable across typical urine specific gravity ranges. | No effect observed from 1.002 to 1.040 for samples at 250, 375, 625, and 750 ng/ml. |
2. Sample Size and Data Provenance for the Test Set
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Sensitivity/Precision Study (around cutoff):
- Sample Size:
- Negative samples (various sub-cutoff concentrations): 60 samples per concentration per format (multi-card, cassette, cup) and 80 for one concentration on dipcard. Totaling: (3 formats * 3 concentrations * 60 samples) + (1 format * 1 concentration * 80 samples) = 540 + 80 = 620 samples for negative range.
- Positive samples (various supra-cutoff concentrations): 60 samples per concentration per format. Totaling: (4 formats * 4 concentrations * 60 samples) = 960 samples for positive range.
- Overall, a significant number of samples were tested multiple times.
- Data Provenance: The study used "standard drug solutions diluted in drug free urine." This suggests controlled laboratory samples, not clinical patient samples. The testing was performed at 3 sites by 2 technicians and repeated over a period of 20 days, indicating internal company studies. The document does not specify countries of origin, but given the manufacturer's location (San Diego, California), it's highly probable it's US-based. It is a prospective study as samples were created and tested for performance evaluation.
- Sample Size:
-
Method Comparison Study (clinical samples):
- Sample Size: 106 unaltered clinical samples.
- Data Provenance: "clinical samples" which implies human urine samples. Since it was conducted for a 510(k) submission in the US, it's likely US-based, although not explicitly stated. The samples were "blinded and sufficiently randomized," indicating a prospective collection and testing for this specific study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Sensitivity/Precision Study: For this study, the "ground truth" was established by the known concentrations of the standard drug solutions prepared in drug-free urine. No human experts were required to establish this ground truth, as it was based on precise laboratory preparation.
- Method Comparison Study: The ground truth for the 106 clinical samples was established by GC/MS (Gas Chromatography/Mass Spectrometry) testing. GC/MS is described as "the preferred confirmatory method" and is considered the gold standard for drug confirmation in toxicology. This is an analytical method, not determined by human experts in the typical sense (e.g., radiologists). While technicians operate GC/MS, their role is to perform the assay and interpret the machine's output, not to make a subjective expert judgment about the presence of a drug.
4. Adjudication Method for the Test Set
- Sensitivity/Precision Study: There was no adjudication method described. The "ground truth" was the known concentration of the samples. The device's qualitative result (positive/negative) was compared directly to this known concentration relative to the 500 ng/ml cutoff.
- Method Comparison Study: The ground truth for the clinical samples was GC/MS testing. There was no adjudication process described beyond comparing the device's qualitative result to the quantitative GC/MS result relative to the 500 ng/ml cutoff. Discordant results were simply listed and not subject to further expert panel review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) rapid test system, not an imaging device typically used by human readers for diagnosis that would benefit from an MRMC study. The "readers" here are laboratory technicians or healthcare professionals at the point of care who visually interpret a color change, not clinical experts evaluating complex data. The performance focuses on the device's accuracy against a gold standard (GC/MS), not on comparing human interpretation with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, the studies presented are representative of standalone performance of the algorithm (the immunoassay). The device (dip card, cassette, cup) directly provides a qualitative result based on its internal chemical reactions, which is then visually read. This is the "algorithm only" performance for such a device, as there isn't a separate algorithmic component that then feeds into human interpretation in a complex way. The results presented directly reflect the device's ability to classify samples as positive or negative. The phrase "typical operators" refers to people performing the test according to instructions; their involvement is in test execution and simple visual interpretation, not complex diagnostic decision-making that would constitute "human-in-the-loop" performance in the sense of advanced AI systems.
7. Type of Ground Truth Used
- Sensitivity/Precision Study: The ground truth was based on known, precisely prepared concentrations of Amphetamine in drug-free urine. This is a form of analytical truth or definitive sample preparation.
- Method Comparison Study: The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) results, which is considered the gold standard confirmatory method for drug detection in urine. This is an analytical truth based on a highly accurate laboratory technique.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay, not a machine learning or AI-driven system that undergoes a separate training phase with data. Its "training" involves the development and optimization of the chemical reagents and test strip design. Therefore, the concept of a separate "training set sample size" as found in AI/ML development is not applicable here. The data presented are for performance evaluation and validation.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and its associated ground truth is not applicable to this type of immunoassay device. The scientific and engineering principles of immunoassay development guide its design, rather than data-driven machine learning training.
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