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The Quest Diagnostics HairCheck-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.

The HairCheck-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free.

The Quest Diagnostics HairCheck-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.
The ELISA Cocaine Kit is based on the competition for a limited number of antibody sites by unlabeled cocaine/cocaine metabolites and enzyme-labeled drug. The two will bind to the antibody in proportion to their concentration in solution.
Once accessioned in the lab, the aluminum foil is opened and the specimen is cut at approxima 3.9 cm from the root end. This specimen is cut into smaller lengths and mixed to ens homogeneity. Ten milligrams of the specimen is weighed out and placed into a properly labeled test tube. The specimen is then washed with methanol, decanted, and then placed in hot methanol containing 0.5% (v/v) trifluoroacetic acid for one hour forty-five minutes. The extracted methanol solution is then transferred to a new tube and evaporated under nitrogen. The tubes are reconstituted with phosphate buffer and assayed using the Cocaine ELISA Kit. This kit is a solid-phase microtiter plate immunoassay in which the microwells are coated with a high affinity capture antibody to cocaine. A hair sample extract is added to the well, followed by the horseradish peroxidase (HRP) enzyme conjugate. During this initial phase, the enzyme conjugate competes with the analyte in the sample for binding sites on the antibody-coated microwells. A wash solution (Tween-20 in phosphate buffered saline solution) is then applied to remove any unbound materials such as excess conjugate and residual sample. Enzyme substrate solution containing 3, 3', 5, 5'-tetramethylbenzidine (TMB) is then added for the final color development process. The reaction is stopped with 1N sulfuric acid and the absorbance is read at 450 nm, with a reference wavelength of 620 nm, using a plate reader. Color intensity is inversely proportional to the amount of analyte present in the sample. Therefore, samples that contain drug or analyte will inhibit binding of the enzyme conjugate to the antibody, resulting in little substrate binding and less color development than in the negative calibrator. For the screening assay an absorbance less than or equal to the absorbance of the 300 pg cocaine/mg hair cutoff calibrator is indicative of the presence of cocaine/cocaine metabolites.

The Quest Diagnostics HairCheck-DT (Cocaine) test system is an in vitro diagnostic device that uses an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine and cocaine metabolites in head hair samples at concentrations at or above 300 pg/mg hair. A positive result from this screening test requires confirmation using a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC/MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml.

The Quest Diagnostics Methamphetamine Micro-Plate EIA 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 (GC/MS) is the recommended confirmatory method.

The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the determination of values in the measurement of methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.

The Ouest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.

Quest Diagnostics Methamphetamine Micro-Plate EIA is a solid phase competitive enzyme immunoassay for the detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device.

The provided text focuses on the 510(k) summary for the Quest Diagnostics Methamphetamine Micro-Plate EIA. It describes the device, its intended use, and states that it is "substantially equivalent" to a predicate device. However, this document does not contain the detailed acceptance criteria or the specific study data that would typically be presented to prove a device meets those criteria.

Generally, for a qualitative diagnostic device like this, acceptance criteria would involve sensitivity and specificity targets, often compared against a gold standard method. The study detailed would describe how these metrics were evaluated.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the given text. The document states that "Performance characteristic studies on precision, analytical sensitivity, interference and antibody crossreactivity showed that the Quest Diagnostics Methamphetamine Micro-Plate EIA is in substantial agreement with the Orasure Methamphetamine Intercept® Micro-Plate EIA." However, specific numerical targets for these performance metrics (e.g., "sensitivity > 95%") and the exact reported performance numbers are absent.

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

This information is not explicitly provided in the given text. The document mentions "Results obtained from patient specimens," but does not specify the number of specimens, the country of origin, or if the data was retrospective or prospective.

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

This information is not provided in the given text. For a device like this, the "ground truth" for methamphetamines is typically established by gas chromatography/mass spectroscopy (GC/MS), not by expert readers.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. As mentioned above, ground truth for methamphetamine detection is established by a definitive chemical method (GC/MS), not by human adjudication of images or other subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers interpret data. For a qualitative immunoassay for drug detection, it's not applicable.

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

Yes, the studies described are inherently "standalone" in the sense that they evaluate the performance of the immunoassay itself in detecting methamphetamine. The device provides a qualitative result based on chemical reactions, not human interpretation. The "Comparison Performance Data" and "Results obtained from patient specimens" refer to the intrinsic performance of the assay.

7. The Type of Ground Truth Used:

The ground truth assumed for validating drug screening tests like this is typically a confirmatory chemical method, specifically Gas Chromatography/Mass Spectroscopy (GC/MS). This is explicitly stated in the "Indications for Use Statement": "To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method."

8. The Sample Size for the Training Set:

This information is not provided in the given text. As a traditional immunoassay, there wouldn't be a "training set" in the machine learning sense. The device is developed based on known chemical reactions and antibody-antigen binding principles. The "performance characteristic studies" would involve various types of samples to characterize the device, but not a "training set" for an algorithm.

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

This information is not applicable. As there is no "training set" in the machine learning context for this type of device, the concept of establishing ground truth for it doesn't apply. Device development involves biochemical engineering and validation against known standards and reference methods (like GC/MS).

In summary, the provided document indicates a determination of "substantial equivalence" based on performance characteristics and patient specimen results being in "substantial agreement" with a predicate device. However, it lacks the detailed quantitative acceptance criteria and the specific study data that would demonstrate how these criteria were met for standalone performance. The focus is on comparing it to an existing, legally marketed device rather than detailing de novo performance against a strict set of predefined acceptance criteria for sensitivity, specificity, etc. This is characteristic of a 510(k) submission where substantial equivalence is the primary pathway to market.

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The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 ng/ml and 150 ng/ml of benzoylecgonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use.

The Quest Diagnostics Urine Cocaine Metabolite EIA 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 (GC/MS) is the recommended confirmatory method.

The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoylecgonine in urine. The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine.

Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the determination of cocaine metabolites in urine specimens.

The provided 510(k) summary describes the Quest Diagnostics Urine Cocaine Metabolite EIA, a competitive homogenous enzyme immunoassay for the qualitative detection of benzoylecgonine in urine specimens.

Here's an analysis of the provided information, focusing on acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for specific performance metrics in a tabular format as one might see for digital health devices. Instead, it demonstrates substantial equivalence to a predicate device by comparing various performance characteristics. The implied acceptance criterion for this type of submission is usually that the new device performs as well as or substantially equivalent to the predicate device, especially when using a reference method like GC/MS.

Notes on Cutoffs: The indications for use specify cutoffs of 300 ng/ml and 150 ng/ml for benzoylecgonine. The performance data would have been evaluated against these cutoffs.

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

The summary states: "Results screened from patient specimens with both the Quest Diagnostics Urine Cocaine Metabolite EIA and the DAT II Cocaine II assay also showed that the qualitative results from this two test systems are substantially equivalent when using GC/MS results as reference."

• Sample Size: The exact number of "patient specimens" used for the test set is not specified in the provided document.
• Data Provenance: The document refers to "patient specimens," implying real-world human samples. However, the country of origin is not specified, nor is it explicitly stated whether the data was retrospective or prospective. Given the context of a 510(k) submission for an in vitro diagnostic, it would typically involve prospective or retrospectively collected de-identified clinical samples.

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

• The ground truth for the test set was established using Gas Chromatography/Mass Spectroscopy (GC/MS).
• GC/MS is an analytical chemical method, not reliant on human expert interpretation in the same way as imaging or clinical diagnosis relies on physicians. Therefore, the concept of "number of experts" or "qualifications of experts" as typically applied to clinical or imaging studies is not directly applicable here. The "experts" would be the technicians or chemists operating the GC/MS equipment, ensuring its proper calibration and interpretation of analytical results, and laboratories performing GC/MS are subject to stringent quality control and accreditation.

4. Adjudication Method for the Test Set:

• Not Applicable. Since GC/MS is an objective analytical method providing a definitive chemical concentration, there is no need for an adjudication method among multiple human readers for establishing ground truth. The GC/MS result itself serves as the unadjudicated "ground truth."

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

• No. This is an in vitro diagnostic device for chemical analysis, not a device requiring human interpretation of medical images or clinical data. Therefore, an MRMC comparative effectiveness study, which typically evaluates improvements in human reader performance with AI assistance, is not relevant or applicable to this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, in essence. The entire study described focuses on the standalone performance of the Quest Diagnostics Urine Cocaine Metabolite EIA (the "algorithm" or device) against a reference standard (GC/MS) and a predicate device. The output of the EIA is a qualitative result (positive/negative based on cutoffs), and its performance is evaluated directly without human intervention needed to interpret the EIA's direct output for the purpose of the study. The "human-in-the-loop" component comes later in clinical practice when a physician interprets the preliminary result in the context of the patient's overall clinical picture, but the device performance itself is standalone.

7. Type of Ground Truth Used:

• The type of ground truth used is analytical chemical confirmation via Gas Chromatography/Mass Spectroscopy (GC/MS). The summary explicitly states: "when using GC/MS results as reference."

8. Sample Size for the Training Set:

• The document does not provide information regarding a separate "training set" or its sample size. This is typical for a traditional immunoassay device. While method development and optimization would have involved extensive testing, the concept of a distinct, labeled "training set" (as in machine learning) is not usually described in 510(k) summaries for these types of IVDs. The "performance characteristic studies" and testing with patient specimens serve as the validation and verification of the final assay.

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

• Since a distinct "training set" with established ground truth, in the context of machine learning, is not described, this question is not applicable as phrased for this device. The development of the assay would have been based on established chemical and immunological principles, and calibration (using calibrators mentioned in the Indications for Use) would be performed using materials with known concentrations, verified by methods like GC/MS.

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QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) is a test system that utilizes the IDS Que-Step ELISA MDMA/Methamphetamine Kit for the qualitative detection of amphetamines at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic methamphetamine use and use of MDMA. This test system has not been evaluated for use with other populations or with hair specimens other than head. It is an in vitro diagnostic device intended exclusively for inhouse professional use only and not intended for sale to anyone.

The QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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This document is a 510(k) clearance letter for a medical device called Quest Diagnostics HairCheck-DT (Amphetamines). The letter indicates that the device has been found substantially equivalent to a legally marketed predicate device. This type of document generally does not contain detailed study results or acceptance criteria in the format requested.

Here's what can be extracted and what cannot:

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

• Cannot be extracted. This document is an FDA clearance letter, not a scientific study report. It does not provide the specific acceptance criteria or detailed performance data from the validation study. It only states that the device was found "substantially equivalent" to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted. The document does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be extracted. This information is not typically included in an FDA clearance letter for a diagnostic test.

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

• Cannot be extracted. This information is not typically included in an FDA clearance letter for a diagnostic test.

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

• Cannot be extracted. This device is an in-vitro diagnostic test for detecting amphetamines in hair, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study with human readers and AI assistance is not applicable.

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

• The device described is a "test system that utilizes the IDS Que-Step ELISA MDMA/Methamphetamine Kit" for "qualitative detection of amphetamines." The "Indications For Use" also state it is an "in vitro diagnostic device intended exclusively for inhouse professional use only." This implies stand-alone performance of the assay kit in a laboratory setting, followed by professional interpretation. However, the exact details of a stand-alone performance study (like sensitivity, specificity, etc.) are not provided in this clearance letter.

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

• The document implies that the ground truth for confirmation of positive results would be established by "A more specific alternate chemical...Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards." This suggests that confirmatory chemical analysis (like GC-MS) is the gold standard/ground truth.

8. The sample size for the training set

• Cannot be extracted. This document does not provide details about a training set, as it is not a machine learning or AI device in the context usually discussed for such sets.

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

• Cannot be extracted. As above, details about a training set are not applicable or provided.

Summary of Extracted Information:

Device Name: Quest Diagnostics HairCheck-DT (Amphetamines)
Regulation Number: 21 CFR 862.3100
Regulation Name: Amphetamines test system
Regulatory Class: Class II

Indications For Use:
QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) is a test system that utilizes the IDS Que-Step ELISA MDMA/Methamphetamine Kit for the qualitative detection of amphetamines at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic methamphetamine use and use of MDMA. This test system has not been evaluated for use with other populations or with hair specimens other than head. It is an in vitro diagnostic device intended exclusively for inhouse professional use only and not intended for sale to anyone.

The QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Breakdown of requested table (with what can be inferred):

This document lacks the detailed performance metrics (sensitivity, specificity, accuracy, etc.) and study design details typically found in a clinical or analytical validation report. It focuses on the FDA's regulatory decision of substantial equivalence based on the provided data that is not detailed in this letter.

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The Quest Diagnostics Hair Check-DT (PCP) is a test system that utilizes the IDS The Quest Diaghoutes Kit for the qualitative detection of Phencyclidine at or above 300 pg/mg in head hair samples. This test system has not been evaluated for use in specific user populations or with hair specimens other than the head. It is an in vitro spoorne asor populations exclusively for in-house professional use only and is not intended for sale to anyone.

The Quest Diagnostics Hair Check-DT (PCP) screening test provides only a I ne Quest Diaghesate ist result. A more specific alternate chemical method must be prominal J analynour a confirmed result. Gas Chromatograph - Mass Spectrometry used in order to obtain a ion monitoring (SIM) mode is the preferred method with operating in the serected inter chemical confirmation methods are available. deateration interiation and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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Here's an analysis of the provided text regarding the Quest Diagnostics HairCheck-DT (PCP) device, addressing your specific points.

It's important to note that the provided documents are a 510(k) summary (or a letter related to it). These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with all the specifics of acceptance criteria, study methodologies, and granular performance data that would be found in a full clinical trial report or validation study. Therefore, some of the information you requested may not be explicitly present or might require inference.

Acceptance Criteria and Device Performance

The provided document (a 510(k) clearance letter and Indications for Use) does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or provide a table of reported device performance in those terms. The clearance states that "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

The key performance characteristic mentioned is the qualitative detection of Phencyclidine (PCP) at or above 300 pg/mg in head hair samples.

However, based on the nature of a 510(k) for a qualitative diagnostic test, acceptance criteria would typically relate to:

• Sensitivity: Ability to correctly identify positive samples (PCP present at or above 300 pg/mg).
• Specificity: Ability to correctly identify negative samples (PCP absent or below 300 pg/mg).
• Accuracy: Overall correct classification rate.
• Precision/Reproducibility: Consistency of results.
• Correlation with a confirmatory method: How well the screening test's preliminary positive results are confirmed by the gold standard (GC-MS).

While actual numerical performance figures or a formal acceptance criteria table are not in the provided text, the core "performance" stated is its ability to qualitatively detect PCP at or above 300 pg/mg.

Study Details from the Provided Text

Given the limited nature of a 510(k) clearance letter, many of the detailed study specifics you requested are not present in the provided document. A 510(k) typically summarizes data submitted, but the full study reports are usually much more extensive.

Here's what can be inferred or explicitly stated:

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

   • Acceptance Criteria: Not explicitly stated as numerical thresholds (e.g., sensitivity > X%, specificity > Y%). The primary "acceptance" is substantial equivalence to a predicate and the ability to detect PCP at/above 300 pg/mg.
   • Reported Device Performance: The primary stated performance characteristic is the "qualitative detection of Phencyclidine at or above 300 pg/mg in head hair samples." No specific sensitivity, specificity, or accuracy figures are provided in this document.

   Performance Metric	Acceptance Criteria (Implied/Typical for 510(k))	Reported Device Performance (from this document)
   Qualitative Detection	Must reliably detect PCP at or above 300 pg/mg threshold and yield valid negative results below threshold; substantially equivalent to predicate.	Qualitatively detects PCP at or above 300 pg/mg in head hair samples. Specific metrics not given.
   Confirmatory Method	Preliminary positive results require confirmation by a more specific alternate chemical method.	Mentions Gas Chromatograph - Mass Spectrometry (GC-MS) in selected ion monitoring (SIM) mode is preferred.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified in the provided documents.
   • Data Provenance: Not specified. It's likely US-based given the FDA clearance, but this isn't explicitly stated.
   • Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Number of Experts: Not specified.
   • Qualifications: For drug testing, the "ground truth" is typically established by confirmatory analytical chemistry methods (e.g., GC-MS) performed by qualified laboratory personnel, not by medical "experts" in the clinical sense (like radiologists). The document explicitly states: "A more specific alternate chemical method must be performed to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry (GC-MS) operating in the selected ion monitoring (SIM) mode is the preferred method..."

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

   • Adjudication Method: Not applicable in the context of analytical drug testing where GC-MS is the gold standard. The GC-MS result forms the objective ground truth. There's no "adjudication" among multiple readers of the primary test as it's an automated or semi-automated qualitative assay.

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:

   • This is not applicable to the Quest Diagnostics HairCheck-DT (PCP). This device is an in vitro diagnostic for drug detection, not an AI-assisted imaging device or a decision support system for human readers. There are no "human readers" to improve in this context. It's a laboratory test.

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

   • Yes, the performance of the "Quest Diagnostics HairCheck-DT (PCP) is a test system..." is inherently a standalone performance evaluated against a confirmed analytical method (GC-MS). It performs the "screening test" qualitatively. Human interaction is for specimen collection, preparation, running the assay, and interpreting the preliminary result, but the "performance" of the device itself is its ability to yield a result.

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

   • The ground truth for this device is based on confirmatory analytical chemistry methods, specifically Gas Chromatograph - Mass Spectrometry (GC-MS) operating in the selected ion monitoring (SIM) mode, for the presence and concentration of PCP in the hair samples. This is the gold standard for drug testing.

8. The sample size for the training set:

   • Training Set Sample Size: Not specified. For in vitro diagnostic assays, the "training set" concept (as used in machine learning) isn't directly applicable in the same way. Development often involves method development, optimization, and internal validation using various panels of known positive and negative samples, and spiked samples. These details are not in the 510(k) letter.

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

   • Similar to the test set, the ground truth for any development or internal validation ("training") would be established through confirmatory analytical chemistry methods (GC-MS), typically against certified reference materials, spiked samples, and clinical samples confirmed by GC-MS.

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The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users. This test system has not been evaluated for use with other user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for sale to anyone

The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document is a 510(k) clearance letter from the FDA for the Quest Diagnostics HairCheck-DT (Opiates) device. It states that the device is substantially equivalent to legally marketed predicate devices. It describes the intended use and indications for use, but it does not detail a study conducted by Quest Diagnostics to establish performance against pre-defined acceptance criteria.

Specifically, the requested information points cannot be extracted from this document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present. The document refers to "head hair samples from chronic heroin users" but does not provide details on the sample size or origin of data from a specific study.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of test system.
6. Standalone performance: The document states the test system "provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed result." This implies it's not truly standalone for a definitive diagnosis.
7. Type of ground truth used: It mentions that GC-MS/MS is the preferred method for confirmation, indicating that this might serve as a form of "ground truth" for confirmed results, but it doesn't detail how ground truth was established for a specific validation study.
8. Sample size for the training set: Not present.
9. How ground truth for the training set was established: Not present.

The document is primarily a regulatory clearance, not a scientific study report. To find the information requested, one would typically need to consult a detailed validation study report submitted as part of the 510(k) application, which is not included in these pages.

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The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens for the purpose of identifying chronic marijuana use. This process is intended exclusively for in-house professional use only. The process has not been evaluated for use with hair specimens other than head. Clinical consideration and professional judgement should be applied to any drug of abuse test result.

The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens.

This document is a 510(k) clearance letter for a drug test, not an AI/ML medical device. Therefore, the questions regarding AI/ML device performance, ground truth, expert involvement, and training/test sets are not applicable to the provided text.

The document discusses the substantial equivalence of the "Quest Diagnostics Haircheck-DT (THC)" device to legally marketed predicate devices for screening and quantifying THC-COOH in hair specimens.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report device performance in a table format. It states that the device is "substantially equivalent" to predicate devices. This implies that its performance is considered acceptable based on comparison to existing, legally marketed tests for the same purpose.

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

Not applicable. This is a 510(k) clearance for a laboratory test, not an AI/ML device requiring a specific test set in the context of algorithm evaluation. The letter refers to the "Indications for Use" which describes what the device does.

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

Not applicable. Ground truth in the context of an AI/ML medical device is not relevant here. The device itself is a test to determine the presence and quantity of THC-COOH.

4. Adjudication method for the test set:

Not applicable.

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 not an AI-assisted device.

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

Not applicable. This is a laboratory test, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" for a drug test would be the actual presence/absence and concentration of the substance in the specimen, as determined by a reference method, but this document does not detail the validation studies beyond stating "substantial equivalence."

8. The sample size for the training set:

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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AML HairCheck-DT (Cocaine) is a process that utilizes the IDS One-Step ELISA Cocaine Kit in which head hair samples undergo forensic testing for the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This process is intended exclusively for in-house professional use only. The process is not intended for sale to anyone.

The AML HairCheck-DT (Cocaine) provides only a preliminary analytical test result. For a quantitative analytical result or for confirmation, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in the selected ion monitoring mode using the deuterated internal standards. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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This document describes the AML HairCheck-DT (Cocaine), a process utilizing the IDS One-Step ELISA Cocaine Kit for the qualitative detection of cocaine in head hair samples.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard). The primary acceptance criterion mentioned is the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine use.

The document refers to the process as providing "only a preliminary analytical test result," with "presumptive positives" requiring confirmation using gas chromatograph-mass spectrometer (GC-MS). This implies the device's performance is gauged by its ability to accurately identify these "presumptive positives" within the specified concentration threshold, which are then subject to a confirmatory method.

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

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The provided text does not mention the number of experts used to establish the ground truth for the test set or their qualifications. Given the nature of drug testing, the "ground truth" would likely be established through a confirmatory analytical method rather than expert consensus on interpretation of the initial ELISA result.

4. Adjudication Method for the Test Set

The provided text does not describe an adjudication method for the test set. Instead, it clearly states that "presumptive positives are analyzed using a gas chromatograph - mass spectrometer," which serves as the confirmatory method rather than an adjudication process between human readers.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a diagnostic test, not a system that assists human readers in interpreting images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is described as "a process that utilizes the IDS One-Step ELISA Cocaine Kit." This implies a standalone performance as the ELISA kit performs the initial qualitative detection. The phrase "in-house professional use only" suggests human intervention in the execution of the test and interpretation of the preliminary result, but the initial detection itself is an algorithmic (chemical reaction-based) process. The subsequent GC-MS confirmation is also a standalone analytical procedure.

7. Type of Ground Truth Used

The ground truth for this device is based on confirmatory analytical testing using a gas chromatograph - mass spectrometer (GC-MS). The text states: "For a quantitative analytical result or for confirmation, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in the selected ion monitoring mode using the deuterated internal standards." This is a highly accurate and widely accepted method for drug confirmation, making it the de facto gold standard for this type of test.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

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

The provided text does not specify how the ground truth for the training set was established. However, it can be inferred that similar to the test set, the ground truth for any training or validation would have been established through robust analytical methods, most likely GC-MS, given its role in confirming presumptive positives.

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