(60 days)
The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine). morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:
| COC | Benzoylecgonine | 300 ng/ml |
|---|---|---|
| MOR2000 | Morphine 2000 | 2000 ng/ml |
| MOR300 | Morphine 300 | 300 ng/ml |
| MET1000 | Methamphetamine 1000 | 1000 ng/ml |
| MET500 | Methamphetamine 500 | 500 ng/ml |
| THC | 11-nor- Delta 9 -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| AMP | Amphetamine | 1000 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |
The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
Not Found
This document is a 510(k) premarket notification from the FDA for a diagnostic device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria in the typical format of a clinical trial or algorithm validation study.
However, based on the provided text, we can infer some aspects and extract what information is present, and explicitly state what is missing.
Here's an analysis based on your request, focusing on the available information:
Device Name: QuickTox™ Multiple Drug Dipcard - COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA
Indications For Use: The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
1. A table of acceptance criteria and the reported device performance
The provided document lists "cutoff concentrations" for each drug, which serve as the analytical acceptance criteria for detecting the presence of that drug. The document does not provide specific reported device performance metrics (like sensitivity, specificity, accuracy, positive predictive value, negative predictive value) against a gold standard for these cutoffs in a study. It only states the intended cutoffs.
| Drug / Metabolite | Cutoff Concentration (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| COC (Benzoylecgonine) | 300 ng/ml | Not Reported in document |
| MOR2000 (Morphine 2000) | 2000 ng/ml | Not Reported in document |
| MOR300 (Morphine 300) | 300 ng/ml | Not Reported in document |
| MET1000 (Methamphetamine 1000) | 1000 ng/ml | Not Reported in document |
| MET500 (Methamphetamine 500) | 500 ng/ml | Not Reported in document |
| THC (11-nor-$\Delta^9$-Tetrahydrocannabinol-9-carboxylic acid) | 50 ng/ml | Not Reported in document |
| AMP (Amphetamine) | 1000 ng/ml | Not Reported in document |
| PCP (Phencyclidine) | 25 ng/ml | Not Reported in document |
| BZO (Oxazepam) | 300 ng/ml | Not Reported in document |
| BAR (Secobarbital) | 300 ng/ml | Not Reported in document |
| MTD (Methadone) | 300 ng/ml | Not Reported in document |
| TCA (Nortriptyline) | 1000 ng/ml | Not Reported in document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document is a regulatory clearance letter, not a study report.
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)
This information is not provided in the document. For drug tests, ground truth is typically established by more definitive analytical methods (e.g., GC/MS), not by expert human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for subjective interpretations (e.g., imaging studies), whereas this device provides visual, qualitative results based on a chemical reaction.
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
An MRMC study is not applicable and was not done as described in the document. This device is an in vitro diagnostic test (a chemical assay), not an AI-assisted diagnostic tool that human readers would interpret. The document refers to "visual, qualitative results for multiple drugs-of-abused in human urine" which implies a direct observation of a color change or line on the dipcard, not interpretation by human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device itself is a standalone test, but it is not an "algorithm" in the typical sense of a software-based AI system. It's a chemical immunoassay. The device provides "visual, qualitative results," meaning a human visually interprets the presence or absence of lines on the dipcard. So, while it's a standalone test, it's not "algorithm-only" and does involve human visual interpretation. The document does not describe a study to evaluate this "standalone" performance against a gold standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for any validation study. For drug screening tests, the ground truth is typically established by a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), which provides highly accurate and quantitative measurements of drug concentrations in urine samples.
8. The sample size for the training set
This information is not provided in the document. As an in vitro diagnostic immunoassay, it doesn't typically have a "training set" in the machine learning sense. Its development involves chemical formulation and optimization.
9. How the ground truth for the training set was established
This information is not provided in the document, as the concept of a "training set" with established ground truth is not explicitly mentioned or applicable in the AI/machine learning context for this type of device based on the provided text. The development of such a device involves analytical validation, likely using spiked samples and clinical samples confirmed by reference methods.
{0}------------------------------------------------
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. Inside the circle is a symbol that appears to be three stylized, curved lines stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Chia Her Quality Manager Branan Medical Corporation 10015 Muirlands Road - Suite E Irvine, CA 92618
DEC 1.6 2002
Re: K023489
Trade/Device Name: QuickTox TM Multiple Drug Dipcard -COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO; DJG; DJC; LDJ; DKZ; LCM; JXM; DIS; DJR; LFG Dated: November 21, 2002 Received: December 3, 2002
Dear Ms. Her:
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. Iisting 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).
{1}------------------------------------------------
Page 2 - .
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page 1 of 1
510(k) Number (if known):
Device Name: QuickTox™ Multiple Drug Dipcard -· COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA
Indications For Use:
The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine). morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:
| COC | Benzoylecgonine | 300 ng/ml |
|---|---|---|
| MOR2000 | Morphine 2000 | 2000 ng/ml |
| MOR300 | Morphine 300 | 300 ng/ml |
| MET1000 | Methamphetamine 1000 | 1000 ng/ml |
| MET500 | Methamphetamine 500 | 500 ng/ml |
| THC | 11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| AMP | Amphetamine | 1000 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |
The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use(Per 21 CFR 801.109)✓ | OR | Over-The-Counter Use(Optional Format 1-2-) |
Jean Cooper
510(k) Number: K023489
§ 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).