Search Results

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.

Not Found

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.

Ask a specific question about this device