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510(k) Data Aggregation
(189 days)
The Immunalysis Benzodiazepines Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Benzodiazepines in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxazepam. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Benzodiazepines Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and Oxazepam. The calibrators are designed for prescription use with immunoassays.
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Benzodiazepine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Benzodiazepines derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative.
All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles.
Here's an analysis of the acceptance criteria and the studies performed for the Immunalysis Benzodiazepines Urine Enzyme Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for all aspects of the testing. However, we can infer the performance expectations from the study descriptions and reported results. The core acceptance for qualitative and semi-quantitative results (positive/negative determination around the cutoff) is that the device should accurately classify samples at various concentrations relative to the 200 ng/mL cutoff, and not be significantly affected by common interferents or physiological variations. For cross-reactivity, it's expected that related compounds will show a response, ideally correlating with their known activity, and unrelated compounds should not cause false positives.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Precision/Cutoff Characterization (Qualitative) | |
| - Samples ≤ 150 ng/mL (negative region) should be Negative. | Table 3: All 80 determinations at 0, 50, 100, 150 ng/mL were Negative. |
| - Samples ≥ 250 ng/mL (positive region) should be Positive. | Table 3: All 80 determinations at 250, 300, 350, 400 ng/mL were Positive. |
| - Samples at 200 ng/mL (cutoff) should show a mixed result, ideally around 50% positive/negative (reflecting assay variability). | Table 3: At 200 ng/mL, 37 Negative / 43 Positive (46.25% Negative / 53.75% Positive), indicating appropriate cutoff characterization. |
| Precision/Cutoff Characterization (Semi-Quantitative) | |
| - Samples ≤ 150 ng/mL (negative region) should be Negative. | Table 4: All 80 determinations at 0, 50, 100, 150 ng/mL were Negative. |
| - Samples ≥ 250 ng/mL (positive region) should be Positive. | Table 4: All 80 determinations at 250, 300, 350, 400 ng/mL were Positive. |
| - Samples at 200 ng/mL (cutoff) should show a mixed result, ideally around 50% positive/negative. | Table 4: At 200 ng/mL, 34 Negative / 46 Positive (42.5% Negative / 57.5% Positive), indicating appropriate cutoff characterization. |
| Specificity/Cross-Reactivity | |
| - Structurally similar compounds should show cross-reactivity at expected levels. | Tables 5 & 6: Shows varying cross-reactivity (e.g., Lorazepam 333.3%, Diazepam 200%, Clonazepam 111.1%), which is expected for benzodiazepines and their metabolites. Many compounds tested POS. |
| - Structurally unrelated compounds should not interfere (no false positives/negatives at ±25% cutoff). | Table 7: All 109 structurally unrelated compounds tested at 100,000 ng/mL (or 500,000 ng/mL for some) showed Negative results at -25% Cutoff (150 ng/mL) and Positive results at +25% Cutoff (250 ng/mL) for both qualitative and semi-quantitative modes, indicating no interference. |
| - Endogenous compounds should not interfere. | Table 8: All 15 endogenous compounds tested at high concentrations showed Negative results at -25% Cutoff (150 ng/mL) and Positive results at +25% Cutoff (250 ng/mL) for both qualitative and semi-quantitative modes, indicating no interference. |
| - Urine pH range (3.0-11.0) should not interfere. | Table 11: No positive or negative interference observed across the entire pH range of 3.0 to 11.0 at ±25% of the cutoff. |
| - Urine specific gravity range (1.000-1.030) should not interfere. | Table 12: No positive or negative interference observed across the entire specific gravity range of 1.000 to 1.030 at ±25% of the cutoff. |
| Linearity/Recovery | |
| - Device should show consistent recovery across a range of spiked concentrations (typically within ±20% of expected). | Table 13: Recovery ranged from 94.2% to 106.8% across expected concentrations from 100 ng/mL to 1100 ng/mL, demonstrating good linearity and recovery. |
| Method Comparison (Qualitative) vs. LC/MS | |
| - High agreement with LC/MS confirmation for positive and negative samples. | Table 14 & 15: 42 true positives, 0 false positives, 1 false negative, 43 true negatives. Agreement for qualitative positive samples (≥200ng/mL by LC/MS results) was 100% (42/42 samples correctly identified as positive by the device). Agreement for qualitative negative samples (<200ng/mL by LC/MS results) was 98% (43/44 samples correctly identified as negative by the device). |
| Method Comparison (Semi-Quantitative) vs. LC/MS | |
| - High agreement with LC/MS confirmation for positive and negative samples. | Table 16: (Table is identical to qualitative, implying the same results for semi-quantitative in terms of classification) Agreement for semi-quantitative positive samples (≥200ng/mL by LC/MS results) was 100% (42/42 samples correctly identified as positive by the device). Agreement for semi-quantitative negative samples (<200ng/mL by LC/MS results) was 98% (43/44 samples correctly identified as negative by the device). |
| Boric Acid Interference | Boric acid should not cause false negative results (implied from other interference studies not causing issues). |
| Table 9 & 10: Boric Acid at 1% w/v was found to cause false negative results at ±25% and ±50% of the cutoff. This indicates a failure to meet the implied non-interference criteria, leading to a labeling limitation. |
2. Sample Size Used for the Test Set and the Data Provenance
- Precision/Cutoff Characterization (Tables 3 & 4): 80 determinations for each concentration level (0, 50, 100, 150, 200, 250, 300, 350, 400 ng/mL). Given 20 days, 2 runs per day in duplicate, this means 20 days * 2 runs * 2 duplicates = 80 determinations. These were spiked drug-free urine samples.
- Specificity and Cross-Reactivity (Tables 5 & 6): For each of the approximately 30 structurally related compounds, a "Result" (POS/NEG) is reported at a specific "Concentration Tested." The exact number of determinations per compound is not explicitly stated but is typically multiple replicates. The samples were drug-free urine spiked with the respective compounds.
- Interference (Structurally Unrelated Compounds - Table 7): For each of the approximately 109 compounds, tests were performed at two concentrations (-25% and +25% of cutoff). The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at ±25% of the cutoff, spiked with the interferent.
- Interference (Endogenous Compounds - Table 8): For each of the approximately 15 compounds, tests were performed at two concentrations (-25% and +25% of cutoff). The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at ±25% of the cutoff, spiked with the interferent.
- Interference (Boric Acid - Tables 9 & 10): Tests were performed at ±25% and ±50% of the cutoff with 1% w/v Boric Acid. The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at these levels.
- Interference (pH - Table 11): Tests were performed at 9 different pH values (3.0-11.0) at ±25% of the cutoff. The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at these levels.
- Interference (Specific Gravity - Table 12): Tests were performed at 8 different specific gravity values (1.000-1.030) at ±25% of the cutoff. The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at these levels.
- Linearity/Recovery (Table 13): 11 different concentrations were tested, each "in triplicate."
- Method Comparison (Tables 14-16): 80 "unaltered, anonymous and discarded clinical urine samples."
- Data Provenance: The Method Comparison study used "unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This implies retrospective data from (presumably) US clinical labs. All other studies (Precision, Specificity, Interference, Linearity) used artificially prepared samples (drug-free urine spiked with controlled concentrations of analytes/interferents).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of in-vitro diagnostic device (IVD) study does not typically involve human experts to establish ground truth in the way medical imaging or pathology studies do. The ground truth for drug presence and concentration in urine samples is established using analytical gold standards like Mass Spectrometry (MS), specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). These are laboratory techniques, not expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable in the human expert sense. For analytical discrepancies between the device and the reference method (LC/MS in the Method Comparison study), standard laboratory protocols for investigating outliers or re-testing would be followed, but there isn't an "adjudication" by a panel of human experts.
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 device is an automated in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Its primary output is a quantitative or qualitative chemical result, not an image or diagnosis requiring human interpretation with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are all standalone performance studies of the device (an immunoassay performed on an automated clinical chemistry analyzer). Its performance is evaluated directly against spiked samples or a reference method (LC/MS) without human interpretative input influencing the device's result. The output itself (positive/negative, semi-quantitative values) then requires professional judgment for clinical application, as stated in the Indications for Use, but the device's analytical performance itself is standalone.
7. The Type of Ground Truth Used
- Mass Spectrometry (MS): For the Precision/Cutoff Characterization, "The spiked concentrations were confirmed by mass spectrometry (MS)." For the Method Comparison study, "Results were obtained... with LC/MS." This is the primary gold standard for determining the true presence and concentration of drugs/metabolites in urine.
- Spiked Concentrations: For precision, specificity, interference, and linearity studies, known concentrations of pure compounds spiked into drug-free urine served as the ground truth.
8. The Sample Size for the Training Set
The document describes an in-vitro diagnostic assay based on immunoassay technology. Immunoassays are fundamentally different from machine learning algorithms that require "training sets." They are analytical chemical reactions with pre-defined reagents and methodologies. Therefore, the concept of a "training set" in the context of machine learning does not apply here. The device's "training" or optimization would involve chemical formulation, antibody selection, and parameter tuning during its development phase, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" as it relates to AI is not applicable to this immunoassay device. The "ground truth" for the development and optimization of such assays relies on analytical chemistry principles, precise formulation of reagents, and verification with reference methods using samples with known, carefully prepared concentrations of analytes.
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