(11 days)
Not Found
Given the provided text, there are no Reference Device(s) K/DEN numbers mentioned. The section "Reference Device(s)" explicitly states "Not Found".
No
The device description and intended use clearly describe a chromatographic immunoassay for rapid detection of substances in urine, which is a traditional chemical/biological test method and does not involve AI or ML.
No
The device is an in vitro diagnostic test for the detection of drugs in urine, not a device used for therapy or treatment.
Yes
The text explicitly states, "The device is intended for professional in vitro diagnostic use only."
No
The device description clearly states it is an "in vitro screen test that contains chromatographic immunoassays," which are physical components used for chemical analysis, not software.
Yes, based on the provided text, the QuickTox™ Multiple Drug Dipcard is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The device is intended for professional in vitro diagnostic use only."
- Device Description: The "Device Description" also reiterates that it is an "in vitro screen test".
- Nature of the Test: The test involves analyzing a biological sample (human urine) outside of the body ("in vitro") to detect the presence of specific substances (drugs and their metabolites) for diagnostic purposes (screening for drug use).
These points directly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 |
|---|---|---|
| MOR | Morphine | 2000 ng/ml |
| MET | Methamphetamine | 1000 ng/ml |
| THC | 11-nor-Δ9-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.
Product codes
DIO, DJG, DJC, LDJ, DKZ, LCM, JXM, DIS, DJR, LFH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
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
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 3 0 2002
Mr. Raphael Wong President Branan Medical Corporation 10015 Muirlands Road. - Suite E Irvine. CA 92618
Re: K022355
Trade/Device Name: QuickTox™ 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; LFH Dated: July 5, 2002 Received: July 19, 2002
Dear Mr. Wong:
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, 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 such 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 1 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" (21CFR 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 Butman
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
2
510(k) Number (if known):
KO22355
QuickTox™ Multiple Drug Dipcard -Device Name: 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 |
|---|---|---|
| MOR | Morphine | 2000 ng/ml |
| MET | Methamphetamine | 1000 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 1-2-96)
Cooper
in Sign-Off)
of Clinical Laboratory Devices
:mber K022355