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510(k) Data Aggregation
(337 days)
The Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt ) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (Methadone) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for Methadone drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/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.
LZI's Oral Fluid Methadone Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect methadone in oral fluid with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the saliva sample for a fixed amount of specific antibody. In the absence of free drug from the saliva sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Here's a breakdown of the acceptance criteria and the study details for the LZI Methadone Oral Fluid Homogeneous Enzyme Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Value (LZI Methadone Oral Fluid Homogeneous EIA) | Reported Performance (LZI Methadone Oral Fluid Homogeneous EIA) |
|---|---|---|
| Accuracy (Agreement vs. GC/MS) | Not explicitly stated as an "acceptance criteria" but implied to be high agreement. | 99.2% Agreement (Clinical patient samples, n=119) |
| Precision | Not explicitly stated as numerical acceptance criteria, but implied to be low %CV. | Within Run Precision (%CV): |
- Negative: 0.58%
- 10 ng/mL: 0.56%
- 20 ng/mL: 0.62%
- 30 ng/mL: 0.57%
- 50 ng/mL: 0.54%
Total Precision (%CV): - Negative: 0.70%
- 10 ng/mL: 0.78%
- 20 ng/mL: 0.70%
- 30 ng/mL: 0.68%
- 50 ng/mL: 0.61% |
| Cutoff | 30 ng/mL (for qualitative detection) | Device designed to detect at this cutoff. |
| Intended Use | Qualitative determination of methadone in human saliva. | Meets this intended use. |
| Specimen Collection | Oral fluid collected with Salivette collector and diluted with 1 mL of buffer. | Designed for use with this collection method. |
| Confirmatory Method | A more specific alternative chemical method (GC/MS preferred) must be used for confirmation. | Device provides preliminary results; GC/MS is preferred confirmatory method. |
| Specificity | Not explicitly stated, but implied to have minimal cross-reactivity. | "See attached Assay package insert" (not detailed in this document) |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy Test Set: n=119 clinical patient samples.
- Precision Test Set: n=120 for qualitative (mA/min) and used to calculate precision (%CV).
- Data Provenance: The document does not explicitly state the country of origin. It refers to "Clinical patients samples" without specifying if they are retrospective or prospective. Given the context of a 510(k) submission for an in vitro diagnostic, these are typically clinical samples collected and tested for validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is an in vitro diagnostic (immunoassay) for drug detection. The ground truth is established by a more definitive laboratory method, not by human expert opinion or interpretation of images.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies where human readers interpret data (e.g., medical images) and their agreement is critical. For this immunoassay, comparison is made against a definitive analytical method (GC/MS).
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 is an automated immunoassay for detecting methadone in oral fluid. It does not involve human readers interpreting data or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The "LZI Methadone Oral Fluid Homogeneous Enzyme Immunoassay" is an automated, standalone assay. Its performance is evaluated independently against a reference method (GC/MS) without human intervention in the interpretation of the initial assay result. The assay provides a "preliminary analytical test result" on its own.
7. The Type of Ground Truth Used
- Confirmatory Analytical Method: Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." and "Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry, an independent analytical method."
8. The Sample Size for the Training Set
- The document describes the validation of the device but does not specify a "training set" or its size. Immunoassays are developed through iterative refinement and validation, but the concept of a distinct 'training set' in the machine learning sense is not typically applied or documented in this type of 510(k) submission. The data provided are for performance evaluation.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As no specific "training set" is mentioned in the context of machine learning, the establishment of its ground truth is not detailed. For the overall development of an immunoassay, the "ground truth" (i.e., accurate concentrations of methadone) would be established using validated reference materials and analytical methods (like GC/MS) during the assay's development and optimization phases.
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(122 days)
The Methadone Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of Methadone Metabolite in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Metabolite Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
LZI's Methadone Metabolite Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect Methadone Metabolite (EDDP) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between Methadone Metabolite labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Lin-Zhi International, Inc.'s Methadone Metabolite Enzyme Immunoassay ({0}-{6}):
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it demonstrates substantial equivalence by comparing the performance characteristics of the LZI device to its predicate device (DRI/Microgenics Corp.'s Methadone Metabolite Enzyme Immunoassay) and showing "acceptable results." The criteria are implied by the performance metrics measured.
| Performance Characteristic | Implicit Acceptance Criterion | LZI's Methadone Metabolite EIA Reported Performance |
|---|---|---|
| Precision (Within Run) | Low %CV (indicating consistency) | Qualitative: |
| Negative: %CV = 0.73 | ||
| 225 ng/mL: %CV = 0.69 | ||
| 300 ng/mL: %CV = 0.72 | ||
| 375 ng/mL: %CV = 0.78 | ||
| 1000 ng/mL: %CV = 0.75 | ||
| Semi-quantitative: | ||
| Quantitates accurately | 225 ng/mL: %CV = 3.88 | |
| 300 ng/mL: %CV = 4.50 | ||
| 375 ng/mL: %CV = 3.40 | ||
| Precision (Run-To-Run) | Low %CV (indicating consistency) | Qualitative: |
| Negative: %CV = 0.74 | ||
| 225 ng/mL: %CV = 0.81 | ||
| 300 ng/mL: %CV = 0.47 | ||
| 375 ng/mL: %CV = 0.63 | ||
| 1000 ng/mL: %CV = 0.93 | ||
| Semi-quantitative: | ||
| Quantitates accurately | 225 ng/mL: %CV = 3.59 | |
| 300 ng/mL: %CV = 3.62 | ||
| 375 ng/mL: %CV = 3.19 | ||
| Sensitivity | Low detection limit | 15 ng/mL |
| Accuracy (Qualitative) | High agreement with a reference method | Vs. GC/MS (n=139): |
| Positive: 100 % agreement | ||
| Negative: 100 % agreement | ||
| Analytical Recovery (Qualitative) | 100% accuracy on positive vs. negative tests | 100% accuracy |
| Analytical Recovery (Semi-quantitative) | Quantitation within a specified percentage of nominal concentration | Quantitates within ±15% of nominal concentration between 30 ng/mL and 900 ng/mL. Average 95.0 % recovery at 225 ng/mL, Average 105.4 % recovery at 375 ng/mL. |
| Specificity | Comparable to predicate device | Comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Study: The accuracy study against GC/MS involved n=139 samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied to be laboratory-based validation data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for the test set (specifically for the accuracy study) was established by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is an analytical chemical method, not an expert human interpretation. Therefore, the concept of "number of experts" and their "qualifications" is not applicable in this context.
4. Adjudication Method for the Test Set
- Since the ground truth was established by an objective analytical method (GC/MS), there was no human adjudication reported or necessary for the test set.
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 MRMC study was performed. This device is an in-vitro diagnostic (immunoassay) for methadone metabolites, not an AI-based imaging or interpretive device that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- This device is a standalone algorithm/kit. The performance data presented (precision, sensitivity, accuracy, recovery, specificity) represents the performance of the immunoassay system itself, without direct human interpretive "in-the-loop" performance affecting the result generation, although human operators perform the test and interpret the final qualitative/semi-quantitative output.
7. The Type of Ground Truth Used
- The primary ground truth used for accuracy comparison was Gas Chromatography/Mass Spectrometry (GC/MS). This is an objective, gold-standard analytical method for confirming drug presence and concentration.
8. The Sample Size for the Training Set
- The document does not mention a training set in the context of machine learning or AI. This is a conventional immunoassay where the reagents are formulated and optimized, but not "trained" on data in the same way an AI algorithm is. The development and optimization of the assay likely involved numerous samples during its formulation, but this is distinct from "training data" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm mentioned for this immunoassay device.
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(70 days)
The Methadone Enzyme Immunoassav is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of methadone in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatorv method. Clinical consideration and professional judgement should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.
LZI's Methadone Enzyme Immunoassav is a ready-to-use. liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect methadone in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between methadone labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
The provided text describes the Lin-Zhi International, Inc. Methadone Enzyme Immunoassay, a device for detecting methadone in human urine. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied by Predicate) / Target | Reported Device Performance (LZI Methadone EIA) |
|---|---|---|
| Within Run Precision: | - Low %CV for qualitative results | Qualitative: |
| Negative | (Predicate: SD 1.0, %CV 0.8) | Mean Rate: 209.4, SD: 1.0, %CV: 0.49 |
| 225 ng/mL | (Predicate: 300 ng/mL, SD 1.6, %CV 0.7) | Mean Rate: 272.8, SD: 1.1, %CV: 0.39 |
| 300 ng/mL | (Predicate: 1000 ng/mL, SD 1.5, %CV 0.5) | Mean Rate: 293.4, SD: 0.7, %CV: 0.25 |
| 375 ng/mL | (No direct predicate comparison) | Mean Rate: 308.2, SD: 0.9, %CV: 0.29 |
| 1000 ng/mL | (No direct predicate comparison) | Mean Rate: 344.9, SD: 1.1, %CV: 0.33 |
| Semi-quantitative: | (Predicate: No data available) | Mean Conc. at 225 ng/mL: 229.2, SD: 2.5, %CV: 1.09 |
| Mean Conc. at 300 ng/mL: 308.5, SD: 3.5, %CV: 1.13 | ||
| Mean Conc. at 375 ng/mL: 391.4, SD: 5.4, %CV: 1.37 | ||
| Run-To-Run Precision: | - Low %CV for qualitative results | Qualitative: |
| Negative | (Predicate: No data available) | Mean Rate: 209.5, SD: 1.1, %CV: 0.51 |
| 225 ng/mL | (Predicate: No data available) | Mean Rate: 271.4, SD: 2.0, %CV: 0.74 |
| 300 ng/mL | (Predicate: No data available) | Mean Rate: 292.3, SD: 1.9, %CV: 0.66 |
| 375 ng/mL | (Predicate: No data available) | Mean Rate: 307.2, SD: 2.6, %CV: 0.84 |
| 1000 ng/mL | (Predicate: No data available) | Mean Rate: 344.1, SD: 2.0, %CV: 0.58 |
| Semi-quantitative: | (Predicate: No data available) | Mean Conc. at 225 ng/mL: 228.0, SD: 7.8, %CV: 3.42 |
| Mean Conc. at 300 ng/mL: 305.1, SD: 10.2, %CV: 3.36 | ||
| Mean Conc. at 375 ng/mL: 379.6, SD: 13.2, %CV: 3.47 | ||
| Sensitivity: | Predicate: 10 ng/mL | 15 ng/mL |
| Accuracy: | Predicate: Vs. a commercial EIA, 100% agreement | Vs. GC/MS: 100% agreement for Positive Samples, 100% agreement for Negative Samples |
| Analytical Recovery: | Predicate: No data available | Qualitative: 100% accuracy on positive vs. negative tests. |
| Semi-quantitative: Quantitates within ±15% of the nominal concentration between 30 ng/mL and 750 ng/mL. | ||
| Average 96.6% recovery at 225 ng/mL level (Cutoff -25%). | ||
| Average 93.7% recovery at 375 ng/mL level (Cutoff + 25%). | ||
| Specificity: | Predicate: See attached DRI's Methadone EIA package | Comparable to the predicate device. |
Note on Acceptance Criteria: The document primarily demonstrates substantial equivalence to the predicate device (Methadone Enzyme Immunoassay by DRI/Microgenics Corp., K972526). Therefore, the "acceptance criteria" are generally implied to be comparable performance to the predicate. Where the predicate had "No data available," the new device presents its own performance which is implicitly considered "acceptable" for the purposes of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for precision studies. For accuracy, it states "100% agreement" for positive and negative samples against GC/MS, but the number of samples is not provided. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). It is implied that these are laboratory studies since the product is an in-vitro diagnostic.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an immunoassay for methadone levels. The primary "ground truth" method cited for accuracy is GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical chemical method, not reliant on human expert adjudication in the same way imaging or clinical diagnosis might be.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense. The "ground truth" for reported accuracy is comparison against GC/MS.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this is not an MRMC study. This device is an in vitro diagnostic assay, not an imaging or interpretive diagnostic system requiring human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (precision, sensitivity, accuracy, analytical recovery, specificity) describe the standalone performance of the Methadone Enzyme Immunoassay. It is an automated assay intended for professional use with clinical chemistry analyzers, meaning its performance is evaluated as the algorithm/reagent system working independently without real-time human interpretation within the assay measurement itself. The "human-in-the-loop" would be lab personnel running the test and interpreting the final quantitative or qualitative result.
7. The Type of Ground Truth Used
The primary ground truth used for the accuracy study is GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly specific and sensitive analytical method considered the gold standard for confirming drug presence and concentration in toxicology.
8. The Sample Size for the Training Set
Not applicable. This document describes an enzyme immunoassay, which is a biochemical assay and not an Artificial Intelligence (AI) or machine learning device that requires a "training set" in the computational sense. The device's performance characteristics are inherent to its chemical and enzymatic reactions, not learned from data. Therefore, there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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(195 days)
The Methadone assay is used for the qualitative analysis of methadone in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose.
The Methadone assay is calibrated with methadone and is specific for methadone.
The Methadone assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/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.
Methadone is an in vitro diagnostic assay for the qualitative analysis of methadone in human urine. The assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.
Here's an analysis of the provided text regarding the Methadone assay, outlining the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Emit® II Methadone assay on SYVA®-30R Analyzer) | Demonstrated by 100% agreement in method comparison. |
| Acceptable correlation with GC/MS (confirmatory method) | 99% agreement with GC/MS. |
| Precision (Within-run and total at various control levels) | Total %CV for controls: range from 0.63% to 0.74%. |
| Qualitative analysis of methadone in human urine with a 300 ng/mL cutoff | Device performs qualitative analysis with a 300 ng/mL cutoff. |
| Limit of Detection (Sensitivity) | 20 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "clinical specimens tested ranged from 231.0 to 40,190.0 ng/mL" for the GC/MS comparison, but the exact number of clinical specimens is not explicitly stated. For the comparison with the predicate device, it also does not explicitly state the number of samples used, only that there was 100% agreement.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth was established by laboratory methods, not expert human review.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by laboratory methods (predicate device and GC/MS), not by human adjudication of opinions.
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
- MRMC Comparative Effectiveness Study: No, an MRMC study was not done. This device is an in vitro diagnostic assay, not an AI-based image analysis or diagnostic assist tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the described performance (concordance with predicate and GC/MS, precision, limit of detection) represents the standalone performance of the Methadone assay as an algorithm/device, without human intervention in the result generation.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- Predicate Device Comparison: The Emit® II Methadone assay on the SYVA®-30R Analyzer served as a reference standard for establishing substantial equivalence.
- Confirmatory Method: Gas Chromatography/Mass Spectrometry (GC/MS) was used as the "gold standard" or confirmatory method to establish the accuracy of the device.
8. The Sample Size for the Training Set
- Training Set Sample Size: This information is not provided in the document. The document describes performance studies, but not the development or training of the assay. For an enzyme immunoassay, there isn't typically a "training set" in the same sense as machine learning algorithms. The assay design and calibration are based on known chemical properties and concentrations of methadone.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: This information is not provided and is not directly applicable in the context of a traditional enzyme immunoassay. The "ground truth" for calibrating such an assay would typically involve using precisely quantified standards of methadone.
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(109 days)
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(39 days)
This homogeneous methadone enzyme immunoassay is intended to be used for aualitative and semi-quantitative determination of methadone in human urine. The assay provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. (નેકડ chromatograph/mass spectrometry (GC/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.
Not Found
The provided text is a 510(k) premarket notification response letter from the FDA regarding a Methadone EIA Assay. This document does not describe the acceptance criteria for the device or the study that proves the device meets those criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information because it is not present in the provided text.
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