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510(k) Data Aggregation
(29 days)
The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off(ng/mL) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 or 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 or 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 |
| FYL | Fentanyl | 1 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 or 1000 |
| MTD | d/l-Methadone | 300 |
| MOP/OPI | Morphine | 300 or 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs.
| Code | Substance | Cut-off(ng/mL) |
|---|---|---|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
| FYL | Fentanyl | 1 |
| MET | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test cup may contain any combination of the drug tests listed in the table above.
This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
The provided FDA 510(k) clearance letter details the performance characteristics of the Deepblue Multi-Drug Urine Test Cup and Deepblue Home Multi-Drug Urine Test Cup. This information allows us to describe the acceptance criteria and the study that proves the device meets these criteria.
It's important to note that this device is a qualitative lateral flow immunoassay for initial drug screening, not a diagnostic imaging AI, so the criteria and study methodology differ significantly from those for an AI-powered diagnostic tool. Specifically, there are no references to AI assistance, human readers, or image adjudication, as these are not relevant to this type of device.
Acceptance Criteria and Device Performance for Deepblue Multi-Drug Urine Test Cups
The acceptance criteria for this type of qualitative immunoassay are primarily based on its analytical performance, specifically its ability to correctly identify the presence or absence of target drugs at specified cutoff concentrations. This is demonstrated through precision/reproducibility studies, analytical specificity (cross-reactivity and interference), and method comparison studies against a gold standard (LC-MS/MS).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the successful demonstration of performance in the analytical and method comparison studies. The goal is to achieve high agreement rates with the confirmatory method (LC-MS/MS) and consistent results at and around the cutoff concentrations.
| Performance Metric Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Consistent results across multiple lots and runs, especially at and near cutoff concentrations. High percentage of correct results for spiked samples at various concentrations. | Across three lots and 25 days of testing (50 runs per concentration), the device showed excellent performance. For concentrations at +50%, +75%, and +100% of cutoff, all results were positive (0-/50+). For concentrations at -50%, -75%, and -100% of cutoff, all results were negative (50-/0+). At the cutoff concentration, there was a mix of positive and negative results, indicating the assay's sensitivity at the threshold (e.g., AMP 1000: Lot 1 had 8-/42+, meaning 8 negatives and 42 positives out of 50 runs). Near the cutoff (e.g., -25% and +25%), expected mixed results were observed, demonstrating the assay's ability to differentiate. |
| Analytical Specificity (Cross-Reactivity) | Minimal cross-reactivity with non-target compounds and sufficient cross-reactivity with known metabolites/analogs to ensure broad detection. | Detailed tables provided showing specific cross-reactivity percentages for various compounds. For example, for AMP 1000, D,L-Amphetamine and D-Amphetamine showed 100% cross-reactivity as expected. For BAR 300, Alphenal showed 200% cross-reactivity, and Phenobarbital showed 150%. For FYL 1, Acetyl fentanyl showed 100%, and Butyryl Fentanyl showed 50%. Norfentanyl showed <0.001%. Many structurally unrelated compounds showed <1% cross-reactivity, demonstrating high specificity. |
| Analytical Specificity (Interference) | No significant interference from common exogenous or endogenous substances (e.g., pH, specific gravity, other medications) that would alter results. | pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 did not affect assay results. Over 100 non-structurally related compounds (e.g., Acetaminophen, Ibuprofen, Caffeine, etc.) showed no interference at 100 µg/mL. |
| Method Comparison (Concordance with LC-MS/MS) | High agreement (concordance) rates with a validated confirmatory method (LC-MS/MS) for both negative and positive samples, especially around the cutoff. | High agreement was observed. For each drug, 80 clinical samples (40 negative, 40 positive based on LC-MS/MS) were tested by three operators. The detailed tables show the number of results identified as positive (+) or negative (-) by each operator compared to the LC-MS/MS classification (Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive). For example, for AMP (1000), Operator A correctly identified 10 drug-free samples as negative, 14 low negative as negative, and 22 high positive as positive. There were discordant results for samples near the cutoff, which is expected for qualitative assays; these are detailed in the "Discordant Results" table. |
| Lay Person Study Acceptance | High agreement rates with expected results when tested by lay users, and clear, easy-to-understand instructions. | High agreement rates were demonstrated across all drug types and concentrations in the lay person study (e.g., AMP 500 showed 90-100% agreement depending on concentration closest to cutoff). All 280 participants found the instructions easy to understand and follow. Flesch-Kincaid read-ability score of Grade 7. |
2. Sample Size Used for the Test Set and Data Provenance
- Analytical Performance (Precision): For each drug, 50 runs were performed per concentration (9 concentrations tested: +100%, +75%, +50%, +25%, cutoff, -25%, -50%, -75%, -100%). This involved using 3 lots of test cups, with 2 runs per day for 25 days. The sample provenance is not explicitly stated as patient data, but rather drug-free urine spiked with controlled concentrations of target drugs. This is typical for analytical validation.
- Analytical Specificity: Urine samples were spiked with various drug metabolites, analogs, and interfering substances. The number of samples per compound tested is not explicitly stated but implied to be sufficient for demonstrating cross-reactivity thresholds.
- Method Comparison Study: For each drug, 80 unaltered urine clinical samples were used (40 negative, 40 positive). The data provenance is "in-house," implying these were from a controlled setting, likely in China where the submitter is located. It is labeled as "clinical samples," suggesting they were derived from human urine. The study was retrospective in nature, as pre-collected samples were tested.
- Lay Person Study: 280 lay persons participated. The samples were prepared by spiking drug-free pooled urine specimens with known drug concentrations and blind-labeled.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For Analytical Performance (Precision & Specificity): The ground truth was established by precise spiking of drugs into drug-free urine samples. The concentrations were confirmed by LC-MS/MS, an advanced analytical chemistry technique. LC-MS/MS is considered a gold standard for quantifying drug concentrations and establishing ground truth in these types of studies, requiring skilled analytical chemists or lab technicians to perform. The number of experts or their specific qualifications (e.g., number of years of experience) are not provided in the document, but the use of LC-MS/MS inherently implies expert execution and interpretation.
- For Method Comparison Study: The ground truth for the 80 clinical urine samples per drug was established by LC-MS/MS results. These results served as the reference against which the device performance was compared. As above, this relies on the expertise of those performing and interpreting LC-MS/MS.
- For Lay Person Study: The ground truth was based on precisely prepared spiked samples with confirmed concentrations by LC-MS/MS.
4. Adjudication Method for the Test Set
- For Analytical Performance (Precision & Specificity): No multi-reader adjudication method (e.g., 2+1, 3+1) is described as relevant. The results are quantitative (spiked concentrations) confirmed by LC-MS/MS, and the device provides a qualitative output (positive/negative) that is directly compared to the expected qualitative outcome from the established concentration and cutoff.
- For Method Comparison Study: Three operators performed the tests. The results from each operator are reported individually ("Operator A," "Operator B," "Operator C"). Discordant results (where the device outcome did not match the LC-MS/MS ground truth, or where operators' results differed) are explicitly listed. There is no explicit mention of an adjudication process among the operators; rather, the data from each operator is presented against the LC-MS/MS reference. This indicates that their individual interpretations are the "reads," and the LC-MS/MS is the adjudication method.
- For Lay Person Study: No explicit adjudication method is described. The results from the lay persons were compared against the known concentrations of the spiked samples.
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
- No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically performed for diagnostic imaging devices where human readers interpret images with and without AI assistance to assess the AI's impact on human performance in a clinical setting. The Deepblue device is a rapid lateral flow immunoassay for drug screening, not an imaging device or an AI-powered system designed to assist human interpretation. Therefore, this section is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence, a "standalone" or "device-only" performance study was done. The "Analytical Performance" section (Precision/Reproducibility and Analytical Specificity/Interference) and portions of the "Method Comparison Study" demonstrate the device's performance based on its inherent physical and chemical properties and its interaction with the sample, irrespective of human interpretation variability (though human operators handle the device and read the result). The "Method Comparison" explicitly compares the device's output to the gold standard (LC-MS/MS) directly. The "Lay Person Study" assesses the ease of use and reads by untrained users, ensuring the device works as intended without specialized human expertise. Since it's a simple qualitative result (presence of a line), "human-in-the-loop" "performance" is primarily about correct reading of a physical characteristic.
7. The Type of Ground Truth Used
The primary type of ground truth used for both the analytical performance and method comparison studies was confirmatory analytical chemistry data, specifically Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS/MS). These methods are considered the gold standard for accurate and quantitative identification of drugs and their metabolites in biological samples.
8. The Sample Size for the Training Set
No specific "training set" or "training" is described, as this device does not use machine learning or AI that requires a distinct data training phase. The development of the immunoassay itself relies on chemical and biological design principles, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML model for this device, a corresponding ground truth establishment process is not applicable. The immunoassay itself is developed and validated through iterative biochemical and engineering processes to ensure sensitivity and specificity to the target analytes.
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