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The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic use.

The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (ELA) provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method.

The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva.

The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite.

LabOne Cocaine Metabolite Micro-Plate ELA is a solid phase competitive enzyme immunoassay for the determination of cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device.

The provided text describes the LabOne Cocaine Metabolite Micro-Plate EIA and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a table format with performance metrics as requested, nor does it detail a study proving the device meets specific acceptance criteria in the comprehensive manner implied by the prompt.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (STC Cocaine Metabolite Micro-Plate EIA) through performance characteristic studies.

Here's an attempt to extract and infer the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance. Instead, it states that various performance characteristic studies showed the LabOne device to be substantially equivalent to the predicate device. The key comparison involved using GC/MS/MS as a reference.

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 or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "patent speciale" (likely a typo for patient samples) and "diluted samples," but no numbers or details on their origin are provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method

The document does not describe any adjudication method.

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

No MRMC study is mentioned. This device is an in vitro diagnostic (EIA), not typically subject to MRMC studies like imaging devices that involve human interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was done in the sense that the LabOne device's "performance characteristic studies" were conducted. The comparison was primarily against a predicate device and then against GC/MS/MS as a reference. The document states:

• "Performance characteristic studies on precision, analytical sensitivity, interference and antibody / cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA."
• "Results [from patient samples and diluted samples] also showed that the [agreement] with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference."

This implies a direct evaluation of the device's characteristics, with GC/MS/MS serving as the "gold standard" ground truth for assessing accuracy in a subset of the tests.

7. Type of Ground Truth Used

The primary ground truth used for assessing accuracy was Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS). The document explicitly states: "GC/MS/MS results as reference." It also mentions "patent speciale" (patient samples) and "diluted samples" being tested with both systems.

8. Sample Size for the Training Set

The document does not provide any information about a training set since this is a diagnostic assay, and the "study" described is for validation, not AI/machine learning model training.

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

Not applicable, as no training set for an AI/ML model is described.

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LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only.

The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva.

The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine.

LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay for the qualitative and semi-quantitative analysis of cotinine in oral fluid specimens collected with the OraSure® Oral Specimen Collection Device.

The provided text describes a 510(k) summary for the LabOne Micro-Plate Cotinine EIA, which is a device for detecting cotinine in oral fluid. However, the document does NOT contain detailed information about specific acceptance criteria and the comprehensive study results to "prove" the device meets them in the way described by the requested table and points.

Specifically, the document states:
"Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent to the OraSure Micro-Plate Cotinine EIA."
And:
"Results tested from self-claimed patient specimens and diluted samples with both the LabOne Micro-Plate Cotinine EIA and the OraSure Micro-Plate Cotinine EIA also showed that the sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references."

This indicates that studies were performed, but the actual acceptance criteria (e.g., minimum sensitivity, specificity, or precision values) and the specific reported device performance values for these criteria are not provided in the summary. The core of the submission is to demonstrate "substantial equivalence" to a predicate device (OraSure Micro-Plate Cotinine EIA, K974234), rather than proving it meets standalone, predefined performance metrics with detailed study data.

Therefore, many of your requested points cannot be directly extracted from the provided text.

Here's an attempt to answer what can be inferred from the document, along with explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document focuses on declaring substantial equivalence to the predicate device, K974234. It states that "performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent" and that "sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references." However, the specific quantitative acceptance criteria (e.g., "precision CV < X%") and the actual performance metrics achieved (e.g., "precision CV was Y%") are not reported in this summary.

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

• Sample Size: Not explicitly stated. The document mentions "self-claimed patient specimens and diluted samples" were tested, but the number of these samples is not provided.
• Data Provenance: Not explicitly stated. However, given the context of a US FDA submission, it's highly likely the data would be derived from studies relevant to the US regulatory environment. The terms "self-claimed patient specimens" suggest human biological samples, but their origin (country, etc.) is not specified.
• Retrospective or Prospective: Not explicitly stated.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Explanation: For an in vitro diagnostic (IVD) device like this, ground truth would typically be established through a reference method or clinical status, rather than expert interpretation of images or other subjective data. So, the concept of "experts" in the context of radiologists, for example, is not applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/not mentioned. This type of adjudication is typically for subjective assessments (e.g., reading medical images). For an IVD like this, ground truth is usually objectively determined via a reference standard or clinical outcome.

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 Study: No. This is an in vitro diagnostic device, not an imaging device requiring human reader interpretation in the same way. The device's performance is compared to a predicate device and reference methods, not human readers.
• Effect size of human readers improvement: Not applicable.

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

• Standalone Performance: Yes, in essence. The device itself (LabOne Micro-Plate Cotinine EIA) is a diagnostic test kit that measures cotinine. Its "performance" refers to how accurately it detects or quantifies cotinine, irrespective of human interpretation in the loop in the way AI applications are often discussed. The comparison data described ("Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity") are effectively standalone performance evaluations against established analytical standards and the predicate device.

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

• Type of Ground Truth: The document mentions "using self-claimed specimen results and urine results as references." This implies that the presence or absence of cotinine, or its concentration, was established using:
  • Self-claimed patient information: Patients' own statements about tobacco use.
  • Urine results: Testing of urine samples (likely using a validated reference method for cotinine) as an independent corroborator.
  • Additionally, the "performance characteristic studies" would rely on controlled samples with known cotinine concentrations or known interfering substances, which serve as a form of ground truth for analytical validity.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not mentioned. For a traditional immunoassay kit like this, there isn't a "training set" in the sense of machine learning algorithms. The device's components (reagents, antibodies, etc.) are developed and optimized, but not "trained" on data in the same way.

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

• Ground Truth for Training Set: Not applicable, as there isn't a "training set" in this context. The development of such a kit would involve significant R&D to select and optimize reagents that provide the desired biochemical specificity and sensitivity. The "ground truth" during this development would be the known concentration of cotinine (or other analytes) in characterization samples.

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