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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

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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.

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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.

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