Search Results

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Here's a breakdown of the acceptance criteria and the studies performed for the CLUNGENE drug tests, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with numerical thresholds for performance metrics. Instead, it presents various performance studies (Precision, Cut-off, Interference, Specificity, Method Comparison, and Lay-user studies) and concludes that the device's performance is "acceptable" and "substantially equivalent to the predicate."

However, we can infer the implied acceptance criteria from the reported results, particularly for the precision and comparison studies, which demonstrate high accuracy around the cutoff concentrations. Essentially, the criteria are met if the tests accurately identify negative samples as negative and positive samples as positive, especially around the cutoff values, with minimal false positives or negatives.

Implied Acceptance Criteria and Reported Performance Summary

Cocaine Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): Similar to Amphetamine, 100% correct results were consistently observed for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive) across all lots and formats. Variability in positive/negative calls occurred at the exact cut-off.

Oxazepam Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): Consistently 100% correct results for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive) across all lots and formats. Variability in positive/negative calls occurred at the exact cut-off. |
| Cut-off Verification | The device should correctly identify samples above the specified cut-off as positive and below as negative. | For Amphetamine, Cocaine, and Oxazepam, all results were positive at and above +25% Cut-off and all negative at and below -25% Cut-off. This confirms the functional cut-off. |
| Interference | No interference from common exogenous or endogenous substances that would lead to false positive or false negative results. | Numerous compounds (physiological and pathological conditions, common drugs) were tested at 100µg/mL. The document states, "Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices." |
| Specificity (Cross-reactivity) | Limited or no cross-reactivity with structurally similar compounds or other common substances at concentrations below relevant clinical levels. | Detailed tables provided for Amphetamine, Cocaine, and Oxazepam showing concentrations that cause a positive result. For instance, L-Amphetamine showed 2% cross-reactivity at 50000 ng/mL compared to D-Amphetamine's 100% at 1000 ng/mL. Similarly, other drugs (e.g., Alprazolam, Clonazepam for Oxazepam) showed varying degrees of cross-reactivity at higher concentrations. The levels are generally much higher than the detection levels for the target drug, indicating reasonable specificity. |
| Effect of Urine Specific Gravity and pH | Accurate results are maintained across a physiological range of urine specific gravity (1.000-1.035) and pH (4-9). | For samples spiked at +/- 25% of Cut-Off levels, all results were positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, regardless of specific gravity or pH. "No differences observed for different devices." |
| Method Comparison (Clinical) | High concordance with the GC/MS reference method, especially for samples clearly positive or negative, and reasonable performance around the cut-off. | Amphetamine, Cocaine, Oxazepam (all formats): High agreement with GC/MS. For "Negative", "Low Negative (-50%)" categories, all device results were negative for most viewers across all formats. For "High Positive (+50%)", all device results were positive. Discrepancies primarily occurred in the "Near Cutoff Negative" and "Near Cutoff Positive" ranges (e.g., a few false negatives or false positives just above/below the GC/MS cutoff). For example, Amphetamine Cassette Viewer A had 1 positive result in "Near Cutoff Negative" and 0 negative results in "Near Cutoff Positive", while Viewer B had 0 positive and 1 negative result respectively. This expected variability is seen across all drugs and device formats. |
| Lay-user Study | High percentage of correct results for clearly positive/negative samples when interpreted by lay users, and ease of understanding instructions. | Amphetamine, Cocaine, Oxazepam (all formats): All lay-user studies showed 100% correct results for -100%, -75%, -50% cut-off (negative) and +50%, +75% cut-off (positive). At -25% and +25% cut-off, accuracy ranged narrowly, typically between 90-95% (e.g., 1-2 incorrect results out of 20 samples), indicating high performance even at concentrations closest to the threshold. All lay users found the instructions easy to follow, and the package insert had a Flesch-Kincaid Grade Level of 7. |

2. Sample Sizes and Data Provenance

• Precision Study:

  • Test Set Sample Size: For each drug (Amphetamine, Cocaine, Oxazepam) and each device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), 3 lots were tested. For each lot, 8 concentrations were tested (ranging from -100% cut off to +100% cut off). Each concentration was tested with 50 replicates (2 runs per day for 25 days).
  • Total (per drug per format): 3 lots * 8 concentrations * 50 replicates = 1200 tests.
  • Provenance: Samples were "prepared by spiking drug in negative samples." These were laboratory-prepared samples. The original "negative samples" are not specified as to country of origin, but the overall context of an FDA submission suggests the intent is for global marketability/regulatory compliance. This is a prospective lab study.

• Cut-off Verification Study:

  • Test Set Sample Size: 150 samples were used per drug/device type (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off).
  • Provenance: "prepared by spiking drug in negative samples." This is a prospective lab study.

• Interference Study:

  • Test Set Sample Size: Urine samples (drug-free and spiked with target drugs at -25% and +25% Cut-Off) were tested with 3 batches of each device for numerous potential interfering substances. Specific numbers per substance are not given, but refers to "summarized in the following tables" which list many compounds.
  • Provenance: Laboratory-prepared spiked urine samples. This is a prospective lab study.

• Specificity (Cross-reactivity) Study:

  • Test Set Sample Size: Not explicitly stated as a total number of samples, but "drug metabolites and other components" were tested using three batches of each device. Similar to interference, these were individual compounds tested for cross-reactivity.
  • Provenance: Laboratory-prepared samples. This is a prospective lab study.

• Effect of Urine Specific Gravity and pH Study:

  • Test Set Sample Size: Urine samples with varying specific gravity (1.000-1.035) or pH (4-9) were spiked with target drugs at -25% and +25% Cut-Off levels. These were tested using three lots of each device.
  • Provenance: Laboratory-prepared spiked urine samples. This is a prospective lab study.

• Method Comparison Studies (Clinical):

  • Test Set Sample Size: For each drug (Amphetamine, Cocaine, Oxazepam) and each device format, 80 unaltered clinical samples were used (40 negative and 40 positive).
  • Provenance: These were "unaltered clinical samples." The country of origin is not specified, but they are clearly retrospective samples (collected from a clinical setting).

• Lay-user Study:

  • Test Set Sample Size: 1680 lay persons participated. Each participant tested 1 blind-labeled sample. For each drug and each device format, there were 7 concentration levels tested (0, 75, 150, 225, 375, 450, 525 ng/mL corresponding to percentages of cutoff) with 20 samples per concentration level. So, 7 concentrations * 20 samples = 140 samples tested by lay users for each drug/device format.
  • Provenance: Urine samples were "prepared at the following concentrations... by spiking drug(s) into drug free-pooled urine specimens." The concentrations were confirmed by GC/MS. This makes them laboratory-prepared samples for a prospective lay-user study.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth for these studies was established by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate analytical chemistry technique considered the "gold standard" for confirming the presence and concentration of drugs in urine. It is an objective laboratory method and therefore does not rely on human experts for establishing ground truth in the same way imaging-based diagnostic tests might use radiologists.

• Method Comparison Studies: The ground truth for these studies was also established by GC/MS results. The document states, "The samples were blind labeled and compared to GC/MS results." For these studies, the device results were compared to the GC/MS results. The method comparison studies mention "three laboratory assistants" who ran the devices, but their role was to operate the device and record its output, not to establish the ground truth.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth was established by GC/MS, which is an objective chemical analysis. There was no human expert adjudication method (like 2+1, 3+1, etc.) needed or performed to establish the ground truth for these studies. The determination of positive/negative by the device was compared directly to the quantitative GC/MS value relative to the specified cut-off.

• Method Comparison Studies: The samples were "blind labeled and compared to GC/MS results." This implies a direct comparison, not an adjudication process involving multiple human readers of the ground truth. The "three laboratory assistants" were viewers of the device results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done in the sense of human readers interpreting the raw urine samples with and without AI assistance (the device) to assess an effect size.
• The "Method Comparison Studies" involved "three laboratory assistants" (viewers) interpreting the results of the device and comparing these to GC/MS. This is a multi-reader study of the device's output, not a study of human readers' improvement with AI (the device) versus without it. The device itself is an "immunochromatographic assay," not an AI algorithm in the typical sense of machine learning in medical imaging.

6. Standalone (Algorithm Only) Performance Study

• Yes, the device's performance is inherently a standalone performance. The "CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays..." which produce a visual result (a colored line or its absence). The studies detailed (Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH) all assess the performance of the device itself (the "algorithm" or immunoassay in this context) against a known standard (GC/MS concentrations). The method comparison and lay-user studies also evaluate how human operators read the device's standalone output.

7. Type of Ground Truth Used

• The primary ground truth used for all performance studies was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is an objective, highly accurate analytical chemistry method used to determine the exact concentration of the target drugs in the urine samples.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for an in vitro diagnostic (IVD) test, which is a immunoassay device, not a machine learning or AI algorithm in the common sense that requires a "training set" for model development. Therefore, there is no mention or requirement for a training set in this context. The device's "training" is inherent in its chemical design and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

• As stated in point 8, there is no "training set" for these immunochromatographic assays. The performance is determined by the specific reagents, antibodies, and manufacturing consistency.

Ask a specific question about this device