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The Alinity c Tricyclic Antidepressants Reagent Kit is a homogeneous enzyme immunoassay intended for use in the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum or plasma at a cutoff concentration of 300 ng/mL on the Alinity c system in patients suspected of drug overdose.

The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS), or for permitting laboratories to establish control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

For In Vitro Diagnostic Use Only.

The Alinity c Tricyclic Antidepressants Reagent Kit is an automated clinical chemistry assay and a homoqeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses polyclonal antibodies that detect most tricyclic antidepressants in serum or plasma. The assay is based on the competition between an enzyme-labeled drug and the drug from the serum or plasma for a fixed number of specific antibody binding sites. In the absence of drug from the sample, the specific antibody binds to the drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the serum or plasma and the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340/416 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The Alinity c Tricyclic Antidepressants Reagent Kit is supplied as a two liquid reagent kit (R1 and R2). They are included within the same kit, see details below:

• Antibody/Substrate Reagent (R1): Contains polyclonal anti-tricyclics antibodies ● (sheep), glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative.
• Enzyme Conjugate Reagent (R2): Contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with nortriptyline in Tris buffer with sodium azide as a preservative.

Here's the breakdown of the acceptance criteria and study information for the Alinity c Tricyclic Antidepressants Reagent Kit, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate predefined table for each test. Instead, the performance studies themselves imply the acceptance criteria by demonstrating successful results within expected ranges for each analytical parameter. I've synthesized these based on common analytical performance expectations and the reported findings.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies (Repeatability): 80 replicates for each of 7 concentration levels (total 560 samples) for qualitative and semi-quantitative modes.
• Precision Studies (Reproducibility): 75 replicates for each of 7 concentration levels (total 525 samples) for qualitative and semi-quantitative modes.
• Spike Recovery: 20 replicates for Low Control (225 ng/mL) and 20 replicates for High Control (375 ng/mL).
• Dilution Linearity: 5 replicates for each of 9 concentration levels (total 45 samples).
• Method Comparison and Accuracy: 50 negative and 50 positive patient specimens (total 100 patient specimens).
• Matrix Equivalency: 50 patient samples (analyzed in 2 replicates each, across 6 different plasma matrices).
• Specificity (Cross-Reactivity): Varies per compound, generally by spiking known amounts into drug-free serum.
• Interference: Low control (225 ng/mL) and high control (375 ng/mL) samples were spiked with various interfering substances.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the patient specimens were retrospective or prospective. It refers to "patient specimens" without further detail on their origin or collection method.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that the test results were "Compared to LC-MS/MS lab testing." LC-MS/MS (Liquid Chromatography/Tandem Mass Spectrometry) is generally considered the gold standard confirmatory method for drug analyses. Therefore, the ground truth was established by this highly specific and sensitive analytical technique, rather than by human expert consensus or pathology in the traditional sense. The document does not specify the number or qualifications of individuals who performed or interpreted the LC-MS/MS tests; it's assumed to be performed by qualified laboratory personnel.

4. Adjudication Method (for the test set)

Ground truth was established by LC-MS/MS, which is an objective chemical analysis method. Therefore, no human adjudication method (like 2+1 or 3+1) was used or needed for establishing the ground truth. Discordant samples were further investigated using additional LC-MS analysis to assess the root cause, indicating a scientific investigation of discrepancies rather than a consensus-based adjudication.

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

No MRMC comparative effectiveness study was done. This device is an automated clinical chemistry assay, an in vitro diagnostic (IVD) reagent kit, and not an AI-powered diagnostic imaging device involving human readers. Therefore, there's no "human readers improve with AI vs. without AI assistance" effect size to report.

6. Standalone Performance Study

Yes, a standalone performance study was done. All the analytical performance studies (Precision, Spike Recovery, Dilution Linearity, Method Comparison, Matrix Equivalency, Specificity, Interference) evaluate the performance of the Alinity c Tricyclic Antidepressants Reagent Kit (i.e., the algorithm/reagent system) independently. The results reported are the performance of the device without human interpretation affecting the primary quantitative or qualitative output of the assay.

7. Type of Ground Truth Used

The primary ground truth used for performance evaluation, particularly for method comparison and accuracy, was LC-MS/MS (Liquid Chromatography/Tandem Mass Spectrometry) results. LC-MS/MS is considered a definitive confirmatory method for drug concentrations.

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. This device is described as a "homogeneous enzyme immunoassay" using "polyclonal antibodies." This indicates a traditional biochemical assay technology, not a machine learning model that requires a dedicated training set. Therefore, this question is not applicable to the technology described.

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

As noted in point 8, this device does not appear to be an AI/ML-based system requiring a training set. If there were any internal development or calibration processes that involved data, the document does not specify them or their ground truth establishment. For traditional IVD assays, performance is typically validated against reference methods and known standards.

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The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum, plasma, or urine of patients at a cutoff concentration of 300 ng/mL in patients suspected of drug overdose.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

For In Vitro Diagnostic Use Only.

The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay using ready to-use liquid reagents. Specific tricyclic antibodies were used to detect most tricyclic antidepressants in serum, plasma, or urine. The test is based on the competition of an enzyme, glucose-6-phosphate dehydrogenase (G6PDH), labeled-drug and the drug from the sample for a fixed amount of specific antibody binding sites. In the absence of the drug from the sample, the specific antibody binds the enzyme-labeled drug and the enzyme activity is inhibited. This phenomenon creates a direct relationship between drug concentration in the sample and the enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The DRI™ Tricyclics Serum Tox assay is supplied as a two liquid reagent kit (Reagent A and Reagent E). Thev are bottled separately within the same kit, see details below:

• Antibody/Substrate Reagent (Reagent A): Contains polyclonal anti-tricyclics . antibodies (sheep), glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative.
• Enzyme Conjugate Reagent (Reagent E): Contains glucose-6-phosphate ● dehydrogenase (G6PDH) labeled with nortriptyline in Tris buffer with sodium azide as a preservative.

The provided document describes the analytical performance of the DRI™ Tricyclics Serum Tox Assay. It details various studies conducted to demonstrate its performance characteristics, but it does not explicitly state specific pass/fail acceptance criteria for each test. Instead, it presents the results of each study, implying that these results met the internal criteria used by the manufacturer for demonstrating sufficient performance and substantial equivalence to the predicate device.

Here's an analysis of the provided information, addressing your points where possible, and noting when the information is unavailable:

1. A table of acceptance criteria and the reported device performance

As mentioned, explicit acceptance criteria (e.g., "Accuracy must be >95%") are not stated in this document. The tables below summarize the reported device performance for several key analytical studies. The implication is that these reported performances were deemed acceptable for the 510(k) clearance.

• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 80/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 10/70 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/80 (Negative/Positive)

Semi-Quantitative Mode (n=80 for each concentration):

• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 80/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 19/61 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/80 (Negative/Positive)
  | Qualitative Mode (n=80 for each concentration):
• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 80/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 68/12 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/80 (Negative/Positive)

Semi-Quantitative Mode (n=80 for each concentration):

• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 80/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 73/7 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/80 (Negative/Positive)
  |
  | Precision (Reproducibility) | Qualitative Mode (n=75 for each concentration):
• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 75/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 30/45 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/75 (Negative/Positive)

Semi-Quantitative Mode (n=75 for each concentration):

• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 75/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 29/46 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/75 (Negative/Positive)
  | Qualitative Mode (n=75 for each concentration):
• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 75/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 61/14 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/75 (Negative/Positive)

Semi-Quantitative Mode (n=75 for each concentration):

• 0 ng/mL to 225 ng/mL (-100% to -25% Cutoff): 75/0 (Negative/Positive)
• 300 ng/mL (100% Cutoff): 66/9 (Negative/Positive)
• 375 ng/mL to 600 ng/mL (+25% to +100% Cutoff): 0/75 (Negative/Positive)
  |
  | Spike Recovery | Low Control (225 ng/mL, n=20): All 20 Negative (Below Cutoff)
  High Control (375 ng/mL, n=20): All 20 Positive (Above Cutoff) | Low Control (225 ng/mL, n=20): All 20 Negative (Below Cutoff)
  High Control (375 ng/mL, n=20): All 20 Positive (Above Cutoff) |
  | Dilution Linearity (Recovery)| Range 96-115% for expected values 125 ng/mL to 1000 ng/mL (average of 5 replicates) | Range 94-118% for expected values 125 ng/mL to 1000 ng/mL (average of 5 replicates) |
  | Method Comparison (Accuracy) | Qualitative Mode (n=117):
• % Negative Sample Agreement: 98% (60/61)
• % Positive Sample Agreement: 100% (56/56)
• % Total Sample Agreement: 99% (116/117)
  Semi-Quantitative Mode (n=117):
• % Negative Sample Agreement: 97% (59/61)
• % Positive Sample Agreement: 100% (56/56)
• % Total Sample Agreement: 98% (115/117) | Qualitative Mode (n=100):
• % Negative Sample Agreement: 96% (48/50)
• % Positive Sample Agreement: 98% (49/50)
• % Total Sample Agreement: 97% (97/100)
  Semi-Quantitative Mode (n=100):
• % Negative Sample Agreement: 96% (48/50)
• % Positive Sample Agreement: 98% (49/50)
• % Total Sample Agreement: 97% (97/100) |
  | Matrix Equivalency | Serum: 50 patient samples total (25 positive, 25 negative). Full agreement for K2 EDTA Plasma, K3 EDTA Plasma, Lithium Heparin Plasma, Sodium Citrate Plasma, Potassium Oxalate Plasma across qualitative and semi-quantitative modes.
  Sodium Heparin Plasma: 45 patient samples (25 positive, 20 negative). Full agreement across qualitative and semi-quantitative modes. | Not applicable (serum comparison) |
  | Interference | Spiking endogenous/exogenous/physiological substances at high concentrations into low and high controls (225 ng/mL and 375 ng/mL) showed accurate detection of controls (negative for low, positive for high), indicating no interference. (See Table 20 for list of compounds and concentrations tested). | Spiking endogenous/exogenous/physiological substances and pH variations (pH 3-11) at high concentrations into low and high controls (225 ng/mL and 375 ng/mL) showed accurate detection of controls (negative for low, positive for high), indicating no interference. (See Table 21 for list of compounds and concentrations tested). Specific gravity (1.004-1.030) also showed no interference. |
  | Specificity (Cross-Reactivity) | Extensive tables (Table 16, 18, 20) are provided listing cross-reactivity percentages for numerous structurally related and unrelated compounds in serum. The study demonstrated cross-reactivity for various TCA drugs and metabolites (e.g., Amitriptyline 100%, Desipramine 120%, Imipramine 157.9%). Minimal to no cross-reactivity (

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This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.

homogeneous tricyclics serum tox enzyme immunoassay

This document is a 510(k) clearance letter from the FDA for a medical device called the "Tricyclic Serum Tox EIA Assay." This letter grants permission to market the device, indicating that it has been found substantially equivalent to a predicate device.

Unfortunately, the provided document {0}, {1}, and {2} does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on the regulatory clearance process and states the intended use of the device. It does not include a performance study report or any data related to method validation or clinical trials that would detail acceptance criteria and a study proving the device meets them.

Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a separate document detailing the device's performance study, such as a summary of safety and effectiveness, would be needed.

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Immunoassay for the qualitative detection of Tricyclic Immunoassay for the quarteline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.

Not Found

This looks like a 510(k) clearance letter for the AccuSign® TCA device, which is an immunoassay for the qualitative detection of Tricyclic Antidepressants (TCA) in human urine. Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter from the FDA is a notification of substantial equivalence for marketing the device, not a detailed technical report of the device's performance or the studies conducted. It refers to a 510(k) submission (K981801) which would contain the study details, but the submission itself is not provided here.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

To answer your questions, I would need access to the actual 510(k) submission document (K981801) or a similar technical report that describes the device's performance characteristics and the clinical or analytical studies conducted.

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Ask a specific question about this device