QUEST DIAGNOSTICS HAIRCHECK-DT (PCP by QUEST DIAGNOSTICS, INC.

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.

Device Description

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AI/ML Overview

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:

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.

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.
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..."
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.
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.
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.
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.
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.
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.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 8 2005

James A. Bourland, Ph.D. Technical Director Quest Diagnostics Incorporated ---------------4230 Burnham Avenue Las Vegas, NV 89119

K042726 Re: Trade/Device Name: Quest Diagnostics HairCheck-DT (PCP) Regulatory Class: Class II Product Code: LCM Dated: April 4, 2005 Received: May 4, 2005

Dear Dr. Bourland:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to the enactment date of the Medical Device Amendments, or to connine.co phor to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Costine Hot (71ct) that to nevice, subject to the general controls provisions of the Act. The Tou may, dicrororo, maines of the Act include requirements for annual registration, listing of general vonations provincitive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oc found in Title 21, vecements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr o tobains of your device complies with other requirements of the Act that I Drims intact a associations administered by other Federal agencies. You must or any I cacial stututes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will allow you to begin marksting your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equiped this , perm premarked nothication. The PDA midning of bassance of the spermits your device and thus, permits your device to proceed to the market. . . . . . .

If you desire specific information about the application of labeling requirements to your device, If you desire specific information about the appear device, please contact the Office of In
or questions on the promotion and advertising of your and and 100 mloss note the of questions on the promotion and acreening co-years . Also, please note the Vitro Diagnostic Device Lyaluation and Bareey an (217). And States of (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket the Ast from the fegulation entitled, "Misoranonig by reisfered to proposibilities under the Act from the You may obtain other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (k) Number: K042726 Device Name: Quest Diagnostics HairCheck-DT (PCP)

Indications for use:

Intended Use and Indications for Use of the Subject Device:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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510(k).

Regulation Number and Section

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