QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) by QUEST DIAGNOSTICS, INC.

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.

Device Description

Not Found

AI/ML Overview

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.

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

Acceptance Criteria Category	Acceptance Criteria (from document, or inferred)	Reported Device Performance (from document, or inferred)
Analyte Detected	Amphetamines (MDMA/Methamphetamine)	Qualitative detection of amphetamines
Cut-off Concentration	≥ 300 pg/mg hair	Detects concentrations at or above 300 pg/mg hair
Specimen Type	Head hair specimens only	Evaluated for use with head hair specimens only
Intended Use	Identifying chronic methamphetamine use and MDMA use	Supports identification of chronic methamphetamine use and MDMA use
Test Output	Preliminary analytical test result	Provides only a preliminary analytical test result
Confirmatory Method	Followed by a specific alternate chemical confirmation	Requires confirmation by methods like GC-MS or GC/MS/MS
Substantial Equivalence	Device is substantially equivalent to a legally marketed predicate device	FDA found the device substantially equivalent to a legally marketed predicate device (Implicitly, the device's performance met criteria comparable to the predicate).

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.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The text is in all capital letters and is oriented to follow the curve of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 2 2005

Mr. James Bourland, Ph.D., DABFT Quest Diagnostics Incorporated 4230 Burnham Ave. Las Vegas, NV 89119-5410

Re: K051161

Trade/Device Name: Quest Diagnostic HairCheck-DT (Amphetamines) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamines test system Regulatory Class: Class II Product Code: DKZ Dated: October 31, 2005 Received: November 1, 2005

Dear Mr. Bourland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Alberto G

Alberto Gutierrez, Ph.D. 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 (if known): K051161

Device Name: Quest Diagnostics HairCheck-DT (Amphetamines)

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(k) Ko 5116.1

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).