(335 days)
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.
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This document describes the AML HairCheck-DT (Cocaine), a process utilizing the IDS One-Step ELISA Cocaine Kit for the qualitative detection of cocaine in head hair samples.
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard). The primary acceptance criterion mentioned is the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine use.
The document refers to the process as providing "only a preliminary analytical test result," with "presumptive positives" requiring confirmation using gas chromatograph-mass spectrometer (GC-MS). This implies the device's performance is gauged by its ability to accurately identify these "presumptive positives" within the specified concentration threshold, which are then subject to a confirmatory method.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not mention the number of experts used to establish the ground truth for the test set or their qualifications. Given the nature of drug testing, the "ground truth" would likely be established through a confirmatory analytical method rather than expert consensus on interpretation of the initial ELISA result.
4. Adjudication Method for the Test Set
The provided text does not describe an adjudication method for the test set. Instead, it clearly states that "presumptive positives are analyzed using a gas chromatograph - mass spectrometer," which serves as the confirmatory method rather than an adjudication process between human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a diagnostic test, not a system that assists human readers in interpreting images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is described as "a process that utilizes the IDS One-Step ELISA Cocaine Kit." This implies a standalone performance as the ELISA kit performs the initial qualitative detection. The phrase "in-house professional use only" suggests human intervention in the execution of the test and interpretation of the preliminary result, but the initial detection itself is an algorithmic (chemical reaction-based) process. The subsequent GC-MS confirmation is also a standalone analytical procedure.
7. Type of Ground Truth Used
The ground truth for this device is based on confirmatory analytical testing using a gas chromatograph - mass spectrometer (GC-MS). The text states: "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." This is a highly accurate and widely accepted method for drug confirmation, making it the de facto gold standard for this type of test.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not specify how the ground truth for the training set was established. However, it can be inferred that similar to the test set, the ground truth for any training or validation would have been established through robust analytical methods, most likely GC-MS, given its role in confirming presumptive positives.
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
§ 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).