(14 days)
"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:
d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml
"Rapid Drug Screen" 8-Panel test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., gas chromatography/mass spectrometry (GC/MS)).
"Rapid Drug Screen" 8-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel).
The document provided is a 510(k) clearance letter from the FDA for a device called "Rapid Drug Screen" 8-Panel test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information typically found in a clinical study report or a more comprehensive submission, which would detail acceptance criteria, device performance, sample sizes, ground truth establishment, etc.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory clearance and indications for use.
To illustrate what would be provided if the information were available, here's a hypothetical structure for the answer, assuming the device performance and study details were present:
Acceptance Criteria and Device Performance Study
This document describes the FDA's 510(k) clearance for the "Rapid Drug Screen" 8-Panel test, but it does not contain the detailed study that proves the device meets specific acceptance criteria. Such information is typically found in the full 510(k) submission, specifically in the clinical or analytical performance study sections, which are not included in this letter.
However, based on the Indications For Use and the nature of such qualitative drug screening tests, the acceptance criteria would most likely revolve around the accuracy (sensitivity and specificity) of detecting the specified drugs at or above their respective cut-off concentrations.
Below is a hypothetical example of how the requested information would be presented if it were available in the provided document:
1. A table of acceptance criteria and the reported device performance
| Drug of Abuse | Cut-off Concentration (ng/ml) | Acceptance Criteria (e.g., Sensitivity ≥ X%, Specificity ≥ Y%) | Reported Device Performance (e.g., Sensitivity, Specificity) |
|---|---|---|---|
| d-Amphetamine | 750 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 98.2%, Specificity: 97.5% |
| Barbiturates | 300 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 97.5%, Specificity: 96.8% |
| Benzodiazepines | 300 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 96.0%, Specificity: 98.0% |
| Benzoyl ecgonine | 225 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 97.0%, Specificity: 97.2% |
| Cannabinoids | 50 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 98.5%, Specificity: 96.5% |
| Methamphetamine | 1000 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 97.8%, Specificity: 97.0% |
| Opiates (codeine) | 225 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 96.3%, Specificity: 97.1% |
| Opiates (morphine-3-gluc.) | 225 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 96.5%, Specificity: 97.3% |
| Phencyclidine (PCP) | 19 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 98.0%, Specificity: 96.9% |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): [Information not available in the provided document. A hypothetical example would be: "Approximately 500 urine samples (250 positive, 250 negative) for each drug target."]
- Data Provenance: [Information not available. A hypothetical example would be: "Retrospective collection from clinical laboratories in the United States and Canada."]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: [Information not available. A hypothetical example would be: "Three clinical toxicologists and two laboratory directors."]
- Qualifications of Experts: [Information not available. A hypothetical example would be: "Board-certified clinical toxicologists with 10-15 years of experience in forensic and clinical toxicology, and laboratory directors with extensive experience in drug screening and confirmation methodologies."]
4. Adjudication method for the test set
- Adjudication Method: [Information not available. A hypothetical example would be: "All discrepancies between initial GC/MS results and expert review were resolved by a third independent expert (3+1 adjudication). For qualitative tests, the primary ground truth would be the confirmatory method, not expert adjudication of the test results itself."]
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
- MRMC Study: [Information not available. Given this is a qualitative immunoassay device from 1998, it is highly unlikely an MRMC study with AI assistance would have been conducted or applicable. This type of study is more common for imaging diagnostics with human interpretation.]
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, for this type of qualitative immunoassay, the reported performance would inherently be a standalone, algorithm-only (or device-only) performance, as it provides a direct qualitative result without human interpretation influencing the device's direct output. The human "in-the-loop" would be reading the test strip. The performance detailed in the table above would represent this standalone performance.
7. The type of ground truth used
- Ground Truth Type: [Information not available in the provided document, but for such a device, it would most certainly be:] "Confirmatory analytical methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the indications for use as the preferred confirmatory method."
8. The sample size for the training set
- Sample Size (Training Set): [Information not available. For a qualitative immunoassay, the "training set" might not be a separate dataset in the same way as machine learning. It would refer to the samples used during assay development and optimization. A hypothetical example: "During assay development and optimization, hundreds to thousands of characterized urine samples (spiked and endogenous) were used."]
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): [Information not available. A hypothetical example: "For spiked samples, the concentration was precisely known. For endogenous clinical samples, the ground truth was established by independent laboratory testing using GC/MS."]
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 20 1998
John B. Dubeck, Esq. American Bio Medica Corporation C/O Keller and Heckman LLP 1001 G Street, NW, Suite 500W Washington, D.C. 20001
Re : K980872 "Rapid Drug Screen" 8-Panel Drug Test Regulatory Class: II Product Code: DIO, DKZ, JXM, DJG, LCM, LAF, LDJ, DIS Dated: March 6, 1998 Received: March 6, 1998
Dear Mr. Dubeck:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix C
1 Page of
510(k) NUMBER (IF KNOWN): K980872
"Rapid Drug Screen" 8 Panel test -DEVICE NAME:
INDICATIONS FOR USE:
"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:
| d-Amphetamine | 750 ng/ml |
|---|---|
| Barbiturates | 300 ng/ml |
| Benzodiazepines | 300 ng/ml |
| Benzoyl ecognine | 225 ng/ml |
| Cannabinoids | |
| (11-nor-9-carboxy-delta-9-THC) | 50 ng/ml |
| Methamphetamine | 1000 ng/ml |
| Opiates (codeine) | 225 ng/ml |
| (morphine-3-glucuronide) | 225 ng/ml |
| Phencyclidine (PCP) | 19 ng/ml |
"Rapid Drug Screen" 8-Panel test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., gas chromatography/mass spectrometry (GC/MS)).
"Rapid Drug Screen" 8-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980872
37
§ 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).