Search Results

The Psychemedics Microplate EIA For Cotinine in Hair is an in vitro diagnostic device for the qualitative detection of cotinine in human head and body hair as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is intended for a single site and uses a cutoff calibrator of 200 pg cotinine/mg hair. This device is intended exclusively for Psychemedics use only and is not intended for sale to anyone.

The Psychemedics Microplate EIA For Cotinine in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/ MS/MS analysis uses a cutoff, after extensive washing of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.

The Psychemedics Microplate EIA For Cotinine in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Cotinine. The screening portion of the test system consists of (1) microplate wells coated with cotinine conjugated to bovine serum albumin (BSA), polyclonal rabbit anti-cotinine, goat antirabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/MS/MS analysis uses a cutoff, after extensive washing of the hair, of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.

Here's a structured summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Psychemedics Microplate EIA for Cotinine in Hair (K192517)

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicitly stating pre-defined "acceptance criteria" as pass/fail thresholds for specific metrics. However, based on the performance testing results, we can infer the implied acceptance criteria.

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

• Comparison Study (EIA vs. LC/MS/MS): A total of 82 samples were utilized.
  • Data Provenance: The document states "Samples were identified for inclusion in the study by screening with a screening assay for cotinine in serum (K974234)." It doesn't explicitly state the country of origin or if they were retrospectively or prospectively collected human hair samples, but implies they are human hair samples.
• Precision Studies (EIA): Not explicitly stated as "test set," but 10 samples were used for intra-assay and 50 samples for inter-assay precision at various levels around the cutoff. These were "negative hair spiked with previously LC/MS/MS-validated calibrator and control spiking solutions."
• Cosmetic Treatments: Sets of 5 cotinine-negative and 6 cotinine-positive samples (total of 11) were used.
• Environmental Contamination: 7 hair samples were exposed to smoke for this specific test.
• LC/MS/MS Recovery from Hair: 5 authentic samples.
• LC/MS/MS Precision, Linearity, LLOQ/LOD: These studies involved spiked samples rather than a separate "test set" of authentic patient samples, with varying numbers of replicates (e.g., 5 analyses, 5 samples for 5 days).
• Sample Stability during Shipping and Storage: 6 samples for shipping stability and another 6 samples for storage stability.

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

The primary "ground truth" for the comparison study and for confirming the EIA results is the Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) method. This is a laboratory-based analytical method, not directly dependent on expert human interpretation of images or clinical signs. The document does not mention human experts establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth is established by the LC/MS/MS analytical method, which is a quantitative measurement, not subject to human adjudication in the traditional sense of multiple readers interpreting a case. The LC/MS/MS confirms positive cotinine levels above a certain cutoff (100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic assay, not an imaging device or AI algorithm requiring human interpretation. The comparison is between the new EIA screening method and the confirmatory LC/MS/MS method.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, a standalone study of the device (Psychemedics Microplate EIA for Cotinine in Hair) was performed in comparison to the LC/MS/MS confirmatory method, which serves as the "gold standard" ground truth. The EIA itself operates independently without direct human intervention in the interpretation of its results (beyond reading the microplate reader output). The final confirmed analytical result is obtained by LC/MS/MS.

7. The Type of Ground Truth Used:

The ground truth used is an alternative chemical method, specifically Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS), which is considered a highly specific and sensitive analytical technique for cotinine detection. This is a form of laboratory/analytical ground truth. The LC/MS/MS analysis uses a cutoff of 100 pg cotinine/mg hair (after extensive washing) with the presence of hydroxycotinine at or above 10 pg/mg hair.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning. The device is a traditional enzyme immunoassay (EIA). The performance studies involve validation of the assay's characteristics (precision, linearity, cross-reactivity, etc.) using spiked samples, negative controls, and a limited number of authentic samples for comparison studies. There isn't a "training set" in the sense of data used to train an AI model.

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

Not applicable, as there is no specific "training set" for an AI model. The calibrators and control materials for the EIA and LC/MS/MS are prepared using drug stocks from commercial vendors with certificates of analysis, and their concentrations are confirmed by LC/MS/MS.

Ask a specific question about this device

The LZI Cotinine II Enzyme Immunoassay is intended for the quantitative determination of cotinine in human urine at the cutoff value of 200 ng/mL when calibrated against cotinine. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Cotinine II Enzyme Immunoassay is a homogeneous enzyme immunoassay with readyto-use liguid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cotinine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound cotinine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Cotinine II Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The R1 solution contains mouse monoclonal anti-cotinine antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with cotinine in buffer with sodium azide (0.09 %) as a preservative.

The provided text describes the LZI Cotinine II Enzyme Immunoassay, its intended use, and performance characteristics, but it does not describe a study that directly establishes acceptance criteria and directly proves the device meets specific acceptance criteria in a structured manner you requested.

The document is a 510(k) Summary of Safety and Effectiveness, which typically outlines the device's characteristics and demonstrates substantial equivalence to a predicate device. It includes performance data such as precision, linearity, and method comparison (accuracy) with clinical samples, which implicitly serve to show the device is safe and effective for its stated intended use. However, explicit acceptance criteria values that the device must meet are not directly listed in a table format with corresponding proof of meeting them.

I will extract the closest information available to address your request, making inferences where necessary based on the context of common performance expectations for such devices.

Here's a breakdown of the information as requested, largely derived from the "Method Comparison - Clinical Samples" and "Precision" sections.

Acceptance Criteria and Device Performance for LZI Cotinine II Enzyme Immunoassay

Note: The document does not explicitly state "acceptance criteria" in a definitive table format with corresponding proof. Instead, it presents performance study results that are implicitly considered acceptable for demonstrating substantial equivalence. The "Reported Device Performance" below is directly from the study results. The "Acceptance Criteria" are inferred based on the observed performance and typical expectations for diagnostic assays.

1. Table of Acceptance Criteria and Reported Device Performance

• 1 sample (128.6 ng/mL LC/MS) was positive by EIA but was between 50% below cutoff and cutoff concentration (100-199.9 ng/mL). The report states it was "discrepant" but the EIA result (positive) aligns with the stated LC/MS value being within the range where a positive result starts to become more likely if it's "near cutoff positive". However, interpreting that specific discrepancy is complex without a clear cut-off definition of "positive" for LC/MS in the table.
• 1 sample (204.2 ng/mL LC/MS) was negative by EIA but was between cutoff and 50% above cutoff concentration (200-299.9 ng/mL). The report states it was "discrepant". | The accuracy study uses LC/MS as the gold standard. The reported percentages reflect agreement for positive and negative results with respect to the 200 ng/mL cut-off. The discrepancies highlight inherent variability near the cutoff. |
  | Accuracy (Qualitative) | High overall agreement with LC/MS, similar to semi-quantitative.| Overall Agreement: ~96.4% for positive, ~98.7% for negative.
  Discrepant Samples:
• 1 sample (128.6 ng/mL LC/MS) was positive by EIA (146.6 mAU) with a qualitative cutoff rate of 126.4 mAU. This sample was LC/MS positive but between 100-199.9 ng/mL, the EIA result was positive.
• 1 sample (204.2 ng/mL LC/MS) was negative by EIA (93.8 mAU) with a qualitative cutoff rate of 126.4 mAU. This sample was LC/MS positive (204.2 ng/mL) but the EIA result was negative. | Similar to semi-quantitative accuracy, with concordance defined by the qualitative response based on mAU compared to a cutoff rate. |
  | Precision (Qualitative) | At 200 ng/mL cutoff, some variability is expected. For concentrations significantly above or below the cutoff, 100% agreement with expected result (positive/negative) is expected. | At 200 ng/mL:
• Within Run (N=22): 10 Neg/12 Pos
• Total Precision (N=88): 51 Neg/37 Pos
  At 250-400 ng/mL: 100% Positive
  At 0-150 ng/mL: 100% Negative | This indicates that at the exact cutoff concentration (200 ng/mL), there is expected variability in classification. This is typical for assays and is why results near the cutoff require careful interpretation and often confirmatory testing. |
  | Precision (Semi-Quantitative)| Same as qualitative. At 200 ng/mL cutoff, some variability is expected. For concentrations significantly above or below the cutoff, 100% agreement with expected result (positive/negative) is expected. | At 200 ng/mL:
• Within Run (N=22): 14 Neg/8 Pos
• Total Precision (N=88): 55 Neg/33 Pos
  At 250-400 ng/mL: 100% Positive
  At 0-150 ng/mL: 100% Negative | The semi-quantitative precision results also show variability at the 200 ng/mL cutoff, with 100% agreement for samples sufficiently above or below the cutoff. This confirms the device's ability to consistently classify samples away from the decision point. |
  | Linearity | Percent recovery between 85% and 115% of expected values across the assay's linear range. | Range 100 ng/mL to 1000 ng/mL: Recovery ranging from 97.9% to 110.8%.
  At 20 ng/mL: 167.5% recovery.
  At 0 ng/mL: N/A (reported 19.3 ng/mL determined). | The device demonstrated good linearity within the critical range for its intended use (100-1000 ng/mL). The higher recovery at 20 ng/mL suggests reduced accuracy at very low concentrations, which is generally not a concern given the 200 ng/mL cutoff. |
  | Cross-reactivity | Minimal or no significant cross-reactivity with common substances, particularly structurally unrelated compounds, at physiologically relevant concentrations or concentrations higher than expected. | Cotinine-related compounds: Some cross-reactivity with compounds like (-) Norcotinine (20.00%) and (R, S)-Norcotinine (23.53%).
  Structurally Unrelated Pharmacological Compounds: "ND" (Not Detected) at high concentrations (e.g., 100,000 ng/mL) for most tested drugs. Negative results for 0 ng/mL cotinine spiked with these compounds, and correct positive/negative results for cotinine controls. | The device largely demonstrates specificity against a wide panel of common drugs and related substances, indicating minimal interference for its intended purpose. Some expected cross-reactivity with specific cotinine metabolites is noted. |
  | Endogenous Interference | No significant interference from common endogenous substances at relevant concentrations. | No significant undesired cross-reactants or endogenous substance interference was observed except for Boric Acid (1000 ng/mL) and Citric Acid (pH 3) (800 ng/mL) which showed interference at ±25% of cutoff and also at ±50% of cutoff. | Most endogenous substances showed no interference. Boric acid and citric acid showed interference, which is important for laboratories to be aware of when testing samples that might contain these substances. |
  | Specific Gravity Interference | No interference observed across the tested range. | No interference was observed in samples ranging from 1.005 to 1.028 specific gravity when spiked with cotinine at control concentrations. | This indicates the device is robust to variations in urine specific gravity, which is a common factor in urine drug testing. |
  | pH Interference | No major interference observed across the tested pH range. | No major interference between pH 3 to pH 11. | This demonstrates the device's robustness across a wide physiological pH range for urine, an important aspect for clinical utility. |

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

• Accuracy (Method Comparison - Clinical Samples):

  • Sample Size: 104 unaltered clinical samples.
  • Data Provenance: Samples were collected by Lin-Zhi International, Inc. (LZI). The country of origin is not specified, but LZI is based in Santa Clara, CA, USA. The samples are indicated to be "clinical samples," implying they were prospectively collected from human subjects for diagnostic purposes. They are referred to as "unaltered," suggesting they were tested as received without intentional modification. The study is retrospective in the sense that these samples were then tested against a new assay.

• Precision:

  • Sample Size: For each cotinine concentration, 22 determinations were made within a run, and a total of 88 determinations were made across multiple runs (2 runs/day for 22 days).
  • Data Provenance: Samples were prepared by spiking a cotinine standard into a "pool of negative human urine." This indicates a controlled laboratory setting (likely in-house at LZI) rather than clinical samples, and thus not tied to a specific country of origin from patients.

• Linearity, Cross-reactivity, Endogenous Interference, Specific Gravity, pH Interference: These studies used spiked samples prepared in a laboratory setting (e.g., "drug free-urine pool," "pool of negative human urine"). The sample sizes for each condition are detailed in the tables (e.g., "10 replicates" for linearity, "replicates" for others).

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

• For the Accuracy (Method Comparison - Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is an analytical laboratory method, not typically performed by "experts" in the sense of clinicians or radiologists. The result from the LC/MS machine is the ground truth. Therefore, the concept of "number of experts" and their "qualifications" is not applicable here as the ground truth is an objective chemical measurement.

4. Adjudication Method for the Test Set

• For the accuracy study, the "ground truth" was established by LC/MS, which is a definitive analytical method. Therefore, no human adjudication method (like 2+1, 3+1 consensus) was used or required for determining the confirmed cotinine concentration. The comparison was directly between the LZI Cotinine II Enzyme Immunoassay results and the LC/MS results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typical for imaging devices where human readers interpret images, sometimes with and without AI assistance, to assess AI's impact on human performance. The LZI Cotinine II Enzyme Immunoassay is an in-vitro diagnostic (IVD) device (a laboratory test), not an imaging device that would involve human readers for interpretation in this manner.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance studies described are essentially standalone evaluations of the LZI Cotinine II Enzyme Immunoassay. The accuracy, precision, linearity, and interference studies assess the analytical performance of the device itself (the "algorithm" in a broad sense, referring to the assay's methodology and reagents) against established reference methods or known concentrations, without requiring human intervention for interpretation beyond operating the automated clinical analyzer and analyzing the data. The results (e.g., ng/mL concentrations or positive/negative classifications) are generated directly by the assay on the automated analyzer.

7. The Type of Ground Truth Used

• Primary Ground Truth for Clinical Accuracy: LC/MS (Liquid Chromatography/Mass Spectrometry) for cotinine concentrations. This is a highly specific and sensitive analytical technique, often considered the gold standard for drug confirmation testing.
• Ground Truth for Other Studies (Precision, Linearity, Cross-reactivity, etc.): Known concentrations of cotinine or other substances (spiked samples) in negative human urine pools.

8. The Sample Size for the Training Set

• The document describes performance studies for device validation. It does not provide information about a "training set" in the context of an AI/machine learning model. This device is an enzyme immunoassay, a chemical assay, not an AI-based diagnostic algorithm that typically undergoes a separate training phase with a large dataset. The "training" for such an assay would be its initial development and optimization, not a dataset-driven training process 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" for an AI/machine learning model is not applicable to this enzyme immunoassay device. Therefore, how its ground truth was established is not relevant here. The development of the assay's chemical reagents and methodology would have involved internal validation and optimization, but not a "training set" in the context of AI.

Ask a specific question about this device

Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DS ™ Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use. The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.

Status DS'" Nicotine is a simple one step immunochromatographic test for the rapid, qualitative detection of cotinine, a major metabolite of nicotine.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes a qualitative immunoassay for cotinine detection to screen for nicotine exposure. The primary study presented is a substantial equivalence comparison to a predicate device.

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: 94 specimens (50 negative and 44 positive).
• Data Provenance: Not explicitly stated, but common for such studies to use clinical samples. No information on country of origin or if it's retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This study does not establish ground truth using human experts. Instead, it compares the new device's results to those of a legally marketed predicate device (K972481; Auto-Lyte Cotinine EIA).

4. Adjudication method for the test set:

• Not applicable, as the 'ground truth' was based on the predicate device's results, not a consensus among human reviewers.

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 a standalone diagnostic test, not an AI-assisted interpretation tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, this study represents a standalone performance evaluation of the device. The 100% correlation found was the device's performance compared to a predicate device, without human intervention in the interpretation process described in the study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this study was the results obtained from a legally marketed predicate device, the Auto-Lyte Cotinine EIA (K972481).

8. The sample size for the training set:

• Not applicable. This device is an immunoassay, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.

This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.

The Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 50, 500 and 5000ng/ml Cotinine in human urine).

Here's a breakdown of the acceptance criteria and the study details for the Cozart EIA Cotinine Urine Kit, based on the provided text:

Acceptance Criteria and Device Performance

Ask a specific question about this device

The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in serum and plasma. For In Vitro Diagnostic Use.

Not Found

This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria or specific study results.

The letter confirms that the STC Cotinine Micro-Plate EIA (Serum and Plasma) device is substantially equivalent to legally marketed predicate devices. However, it does not detail the studies performed to demonstrate this equivalence or the performance characteristics required for clearance.

Therefore, I cannot provide the requested information from this document. It lacks details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Ask a specific question about this device

The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Not Found

The provided document is a 510(k) clearance letter for the "STC Cotinine Micro-Plate EIA" device. It does not contain the detailed study information required to answer all parts of your request. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for test and training sets.
• Information on MRMC studies or standalone algorithm performance.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the device (K974234).
• The regulatory classification (Class II, Product Code MKU).
• General controls and applicable regulations.
• The intended use of the device.

Therefore, I cannot provide a complete answer to your request based solely on the provided text. I can, however, extract the Indications for Use as this is the only performance-related information explicitly stated:

Indications For Use: The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

To answer your request thoroughly, I would need access to the actual 510(k) submission document (K974234) which details the validation studies conducted for the device.

Ask a specific question about this device

The STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.

Not Found

I am sorry, but the provided text does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting. The document is an FDA 510(k) clearance letter for the STC Auto-Lyte® Cotinine EIA, indicating that it has been found substantially equivalent to a predicate device.

It specifies:

• Device Name: STC Auto-Lyte® Cotinine EIA
• Indications For Use: Homogeneous immunoassay for qualitative and semiquantitative analysis of cotinine in human urine, useful in detecting cotinine after nicotine ingestion or exposure. For In Vitro Diagnostic Use.
• Regulatory Class: II

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication method for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
4. Stand-alone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

This document is a regulatory approval, not a performance study report. To find the information you are looking for, you would typically need to refer to the 510(k) submission itself or related study publications if they exist.

Ask a specific question about this device