The Forsure One Step Single or Multiple (X) Drug Screen Strip of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene Test device are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml . Phencyclidine at a cutoff concentration of 25 ng/ml, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.

Device Description

New Bay Forsure Rapid One Step Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone, 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

AI/ML Overview

The provided text describes a medical device, the Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup Device, but does not include a study or data proving it meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested details cannot be extracted from the provided input.

Here's a breakdown of what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" or present a table of device performance against such criteria. It lists cutoff concentrations for various drugs, which serve as a de facto performance threshold for the qualitative detection. However, it does not provide sensitivity, specificity, accuracy, or other performance metrics.

Test	Analyte or Metabolite(s) to be Determined	Cut-off (ng/ml) (Implied Acceptance Criteria)	Reported Device Performance (Not Provided)
Amphetamine	D-Amphetamine	1000	Not provided
Methamphetamine	(+) Methamphetamine	1000	Not provided
Cocaine	Benzoylecgonine	300	Not provided
Cannabinoid	(-)11-nor-9-carboxy-delta 9 THC	50	Not provided
Opiate	Morphine	2000	Not provided
Benzodiazepine	Oxazepam	300	Not provided
Phencyclidine	Phencyclidine	25	Not provided
Methadone	(+/-) Methadone Hydrochloride	300	Not provided
Oxycodone	Oxycodone Hydrochloride	100	Not provided
Tricyclic Antidepressant	Nortriptyline Hydrochloride	1000	Not provided
Barbiturates	Secobarbital	300	Not provided
Propoxyphene	(+) Propoxyphene	300	Not provided

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 filing is a 510(k) summary focused on substantial equivalence to existing devices, not a detailed report of clinical study results.

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. The ground truth is established using a Gas Chromatography/Mass Spectrometry (GC/MS) system, which is a laboratory method, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. The ground truth is established by GC/MS, not human interpretation requiring adjudication.

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

This is not applicable. The device is an immunoassay test cup for drug screening, which is visually read. There is no AI component or human reader interpretation in the context of an MRMC study described. The document states "None, Visual read single use" under instrumentation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a standalone immunoassay test that provides a visual reading. The performance described would inherently be "standalone" in that it produces a result without human interpretation of complex data. However, the document does not detail specific performance studies, only cut-off concentrations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."

8. The sample size for the training set

This information is not provided. The document describes an immunoassay device, not an algorithm that would typically have a "training set" in the machine learning sense. If the question implicitly refers to samples used during the development or validation of the immunoassay, that data is not included.

9. How the ground truth for the training set was established

This information is not provided. As above, the concept of a "training set" is not directly applicable in the context of the provided information about this immunoassay device.

Summary

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Sep 23, 2005 SECTION II 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510{k) Number:

KOS 2882

Submitter:

Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District. Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516

Contact Person:

Rodrigo Berlie New Product Development Director Telephone: (760) 822-6517 Facsimile: (760) 602-2999

Preparation Date:

Sep. 28, 2005

Device Information:

Device Classification Name:

Immunoassay Of Amphetamine, Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine. Benzodiazepine, Barbiturates, Marijuana. Methadone , Oxycodon , Tricyclic antidepresant and Propoxyphene.

Common/Usual Name:

Immunoassay Test System for Detection of Single or Multiple(X) Abuse Drug Screen Test Cup Device in Human Urine.

Proprietary Name:

Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup Device for Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene.

Regulation Number: 21 CFR8862.3650

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Regulatory Name:

Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine,Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene test system.

Product Code: DJG Regulatory Class: Class II

Predicate Devices:

Rapid One Step Single and Multiple (X) Abuse Drug Screen Test Cup Device is substantially equivalent to Monitect Multiple Drug Screen Test of Branan Medical Corporation, cleared by FDA( K004034), or Alfa Scientific Design Instant-View Propoxyphene (PPX) urine test cleared by FDA ( K022915 )and GC/MS for its stated intended use.

Device Description:

Intended Use:

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concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml . Phencyclidine at a cutoff concentration of 25 ng/ml, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.

Comparison to Predicate Device(s):

Forsure Multiple Rapid One Step Drug Screen Test is substantially equivalent to Branan's Monitect Drug Screen Cassette Test system cleared by FDA, e.g., the Brana's Monitect Assay (004034 )and GC/MS for its stated intended use.

DeviceCharacteristics	Subject Device	Predicate Devicce(s)	Predicate Device(S)
Intended Use	Forsure Multiple DrugScreen one stepImmunochromatographicQualitative test .The assay provides a simpleand rapid analyticalscreening procedure todetect different abuse drugin human urine	Monitect Drug ScreenCassette Assay ( K004034)and GC/MSMonitect Multiple DrugScreenimmunochromatographicassay for qualitativedetermination of thepresence of different drug inhuman urine.	Instant-View PropoxyphensUrine test(K022915) andGC/MSInstant View Drug ScreenImmunochromatographicAssay for qualitativeDetermination of thepresence of PropoxypheneIn human urine.
Analytes	Amphetamine,Methamphetamine,Benzoylecgonine,Benzodiazepine, Marijuana,Morphine, Phencyclidine,Methadone , Oxycodone ,Tricyclic Antidepressant,Barbiturates andPropoxyphene	Amphetamine,Methamphetamine,Benzoylecgonine,Benzodiazepine, Marijuana,Morphine, Phencyclidine,Methadone, Oxycodone,Tricyclic Antidepressant,and Barbiturates .	Propoxyphene
Cutoff	Amp;1000 ng/ml,Mamp:1000 ng/ml,BEG :300 ng/ml,THC : 50 ng/ml.MOR; 2000 ng/ml.PCP :25 ng/ml.BZD: 300 ng/ml,MAD: 300ng/ml,OXY:100 ng/ml,TCA: 1000 ng/ml,PPX: 300 ng/ml	Amp;1000 ng/ml,Mamp:1000 ng/ml,BEG :300 ng/ml,THC : 50 ng/ml.MOR; 2000 ng/ml.PCP :25 ng/ml.BZD: 300 ng/ml,MAD: 300ng/ml,OXY:100 ng/ml,TCA: 1000 ng/ml,	PPX : 300 ng/ml

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DeviceCharacteristics	Subject Device	Predicate Device(s)Monitect Drug ScreenCassette Assay ( K004034)and GC/MS	Predicate Device(S)Instant-View PropoxyphensUrine test(K022915) andGC/MS
Matrix	Urine	Urine	Urine
Calibrator	None	None	None
Instrument	None, Visual read single use	None, Visual Read Single Use	None, Visual Read Single Use
Calibration ofReagent	None	None	None
Storage	Below 28 °C until expiration	15°C - 30°C until expiration date	15°C — 30 °C untilexpiration date

Summary:

The information provided in this pre-market notification demonstrates that Forsure Rapid One Step single or Multiple (X) Abuse Drug Screen Test Cup Device is substantially equivalent to Branan's Monitect Multiple Drug Screen Cassette Test system or Alfa Scientific design Instant-View Propoxyphene Urine Test and GC/MS.

Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the Forsure Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device is safe and effective for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized abstract symbol resembling three curved lines or strokes, often interpreted as representing the human form or a stylized flame. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20050

Public Health Service

Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlie New Product Development Aventir Biotech, LLC. 3108 Avenida Olmeda Carlsbad, CA 92009

K052882 Re:

K022062
Trade/Device Name: Forsure Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device for Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Cannabinoid, Morphine, Denzoyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates, Propoxyphene.

FEB 1 5 2006

Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Chass II
Product Code: DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, DJG, LCM, JXN, LFH Dated: February 6, 2006 Received: February 7, 2006

Dear Mr. Berlie:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2017-11-11 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 I ou may, morelore, mains 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 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 or any I oderal station and 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).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maneting your maneting your device to a legally prematics notification: "The PDT Intentig cification 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, If you desire specific mornialion and advertising of your device, please contact the Office of In of quostions on the promise Evaluation and Safety at (240) 276-0484. Also, please note the v no Diagnostic DoMeo Lrance to reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the Tou may obtain other general memational 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/industry/support/index.html.

Sincerely vours,

Alberto Guts

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

510(K) Number (If Khowi);
Device name: Forsure Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device for Amphetamine , Methamphetamine , Benzoylecgonine , Benzodiazepine , Device for Amplietanine , Nethampliountine , Donal July , Tricyclic Antidepressant ), Barbiturates and Propoxyphene.

Indications for Use:

Thurcations for Use.
Forsure Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device for Forsure Rapid One Step Billiers of Maniphetamine, Benzoylecgonine , Benzodiazepine, Delection of Ampline, Phenispheanine, Methadone , Tricyclic Antidepressant ,
Cannabinoid , Morphine, Phencyclidine, Methadone , Oxycodone , Tricyclic Antidepressant , Camabilion', Morphille, I heleyondine, institutions and the following cutoff concentrations :

Test	Analytes or metabolitesto be determined	Cut-off (ng/ml)
Amphetamine	D-Amphetamine	1000
Methamphetamine	(+) Methamphetamine	1000
Cocaine	Benzoylecgonine	300
Cannabinoid	(-)11-nor-9-carboxy-delta 9 THC	50
Opiate	Morphine	2000
Benzodiazepine	Oxazepam	300
Phencyclidine	Phencyclidine	25
Methadone	(+/-) Methadone Hydrochloride	300
Oxycodone	Oxycodone Hydrochloride	100
TricyclicAntidepressant	Nortriptyline HydrochlorideSecobarbital	1000
BarbituratesPropoxyphene		300
	(+) Propoxyphenc	300

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas alternatography /Mass spectrometry (GC/MS) is the preferred confirmatory method. The testing and results are intended to be used by medical professional and clinical setting. Over-The-Counter Use AND/OR Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Bowen
__
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): 1< 052882

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).