(300 days)
LCM
Not Found
No
The summary describes a qualitative chemical detection test for a substance in hair samples. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies.
No.
The device is a test system for the qualitative detection of Phencyclidine in head hair samples, providing a screening test result. It is not designed to treat or alleviate any medical condition, which is the primary function of a therapeutic device.
Yes
The device is described as a "test system that utilizes the IDS The Quest Diaghoutes Kit for the qualitative detection of Phencyclidine" and "screening test provides only a preliminary result. A more specific alternate chemical method must be performed to obtain a confirmed result." This indicates its purpose is to detect the presence of a substance, which is a diagnostic function.
No
The device is described as a "test system" that utilizes a "kit" for the detection of a substance in hair samples. This strongly implies the use of physical reagents, laboratory equipment, and a testing process that is not solely software-based. The description focuses on the analytical method and the sample type, not on software functionality.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states, "It is an in vitro spoorne asor populations exclusively for in-house professional use only". The term "in vitro" is a key indicator of an IVD.
- Nature of the Test: The device is described as a "test system" for the "qualitative detection of Phencyclidine... in head hair samples". This involves testing a biological sample (hair) outside of the body to diagnose or detect a substance, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
LCM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head hair samples
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-house professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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Page 2 -
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
2
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:
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Albert LS
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Office of In Vitro Diagnostic
Device Evaluation and Safety
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510(k).