(335 days)
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No
The summary describes a laboratory process utilizing an ELISA kit and GC-MS for drug detection, with no mention of AI or ML technologies.
No.
The process is for forensic testing and qualitative detection of cocaine in hair samples, not for treating a disease or condition.
Yes
The device is described as a process for the "qualitative detection of cocaine" and provides "preliminary analytical test result" for the purpose of "identifying chronic cocaine use." This aligns with the definition of a diagnostic device, which is used to identify or detect a disease, condition, or, in this case, the presence of a substance indicative of a condition (cocaine use).
No
The description explicitly states the device is a "process that utilizes the IDS One-Step ELISA Cocaine Kit," which is a physical kit containing reagents and likely other hardware components for performing an ELISA test. This indicates the device is not solely software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- In Vitro: The process involves testing a biological sample (head hair) outside of the living body.
- Diagnostic: The intended use is to detect the presence of cocaine in the hair sample for the purpose of identifying chronic cocaine use. While it provides a preliminary result and requires confirmation, the initial test is a diagnostic step in determining the presence of a substance.
The description explicitly states it's a "process that utilizes the IDS One-Step ELISA Cocaine Kit," and ELISA kits are a common type of IVD used for detecting substances in biological samples.
Therefore, the AML HairCheck-DT (Cocaine) process, as described, fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DJO, DLJ, DIF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
head hair samples
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-house professional use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
0
KC236626
510 (k) Number:
Device Name: AML HairCheck-DT (Cocaine)
Indications for use:
-
- Intended Use and Indications for Use of the Subject Device:
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.
- Intended Use and Indications for Use of the Subject Device:
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ズ (Per 21 CFR 801.109) or
Over-The-Counter-Use (Optional Format 1-2-96)
Donald J. R.
(Division Sign-Off)
(Division Sign-Off) Division of Clinical Laboratory 510(k) Number
Image /page/0/Picture/13 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes the letters 'SK' followed by the number '08'. Below 'SK08', there are the letters 'TX' and what appears to be a symbol or character that resembles a hashtag or a double vertical line. The handwriting is somewhat rough and the text is slightly tilted.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol that resembles a human figure or a caduceus, with flowing lines representing movement or connection. The logo is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2004
James Bourland, Ph.D. Quest Diagnostics Incorporated 4230 Burnham Avenue Las Vegas, NV 89119-5410
Re: K023626
Trade/Device Name: Quest Diagnostics HairCheck-DT (Cocaine) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO; DLJ: DIF Dated: July 17, 2003 Received: July 21, 2003
Dear Dr. Bourland
This letter corrects our substantially equivalent letter of September 29, 2003. The trade name stated AML HairCheck-DT is corrected to Quest Diagnostics HairCheck-DT (Cocaine).
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 [{{or 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2- Dr. James Bourland
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-_. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, D.V.M.
Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health