QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 by BRANAN MEDICAL CORP.

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.

Device Description

AI/ML Overview

The provided document is a 510(k) clearance letter for the QuickTox™ Multiple Drug Dipcard. It describes the device's intended use and the cutoff concentrations for various drugs, but it does not contain a study or data proving the device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the document.
Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method: Not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not provided.
Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable as this is a physical diagnostic device, not an AI algorithm.
Type of ground truth used: Not provided.
Sample size for the training set: Not applicable as this is a physical diagnostic device, not an AI algorithm.
How the ground truth for the training set was established: Not applicable as this is a physical diagnostic device, not an AI algorithm.

What the document does provide:

The document primarily serves as an FDA clearance letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies:

Trade/Device Name: QuickTox™ Multiple Drug Dipcard-COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA
Regulation Number and Name: 21 CFR 862.3250, Cocaine and cocaine metabolite test system (and other product codes for the other drugs)
Regulatory Class: Class II
Indications For Use: 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.
Cutoff Concentrations (which could be considered part of the "acceptance criteria" for qualitative detection thresholds):

Drug	Metabolite/Compound Assessed	Cutoff Concentration
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

Intended Use Details: Used to obtain visual, qualitative results for multiple drugs-of-abuse in human urine. Intended for professional in vitro diagnostic use only, not for over-the-counter sale.

To obtain the detailed study information you requested (like sample sizes, ground truth establishment, performance metrics beyond cutoffs), one would typically need to review the original 510(k) submission summary or associated scientific literature, which is not provided in this document. The FDA clearance letter summarizes the regulatory decision, but not the underlying technical validation studies in detail.

Summary

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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.

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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

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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:

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

(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)

Over-The-Counter Use _

(Optional Format 1-2-96)

Cooper
in Sign-Off)
of Clinical Laboratory Devices
:mber K022355

Regulation Number and Section

§ 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).