Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chromatographic immunoassay, which is a chemical reaction-based test. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.

Therapeutic

No
The device is a diagnostic device used to screen for the presence of illicit drugs in urine, not a therapeutic device for treating an illness or condition.

Diagnostic

Yes

The device performs a "qualitative determination of the presence" of various substances in human urine, which is a form of diagnostic screening. It screens for multiple drugs and drug metabolites, which falls under the umbrella of diagnostic testing for the presence of specific conditions (drug use).

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical chromatographic immunoassay strip or cup device that uses chemical reactions and visual interpretation of color bands to detect drugs in urine. There is no mention of software as a component of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative determination of the presence of [various drugs] in human urine." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide diagnostic information (presence of drugs).
Device Description: The description details a "Chromatographic immunoassay" that analyzes a "test sample" (urine) using antibodies and conjugates to detect the presence of specific substances. This is a common methodology for IVD tests.
Intended User / Care Setting: The intended users are "medical professional and clinical setting," which aligns with the typical use of IVD devices.

The fact that it analyzes a biological sample (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs) is the key indicator that it is an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Indications for Use:
Forsure Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device for Detection of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Cannabinoid, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene, is a rapid visual immunoassay for the qualitative detection of Amphetamine, Methamphetamine, Benzoylecgonine, Cannabinoid, Morphine, Phencyclidine, Methadone, Benzodiazepine, Phencyclidine, Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene at the following cutoff concentrations :

Test	Analytes or metabolites to 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
Tricyclic Antidepressant	Nortriptyline Hydrochloride	1000
Barbiturates	Secobarbital	300
Propoxyphene	(+) 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 chromatography /Mass spectrometry (GC/MS) is the preferred confirmatory method. The testing and results are intended to be used by medical professional and clinical setting.

Product codes (comma separated list FDA assigned to the subject device)

DJG, DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, LCM, JXN, LFH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professional and clinical setting.

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K004034, K022915

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

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:

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.

Intended Use:

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

2

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.

| Device

Characteristics	Subject Device	Predicate Devicce(s)	Predicate Device(S)
Intended Use	Forsure Multiple Drug
Screen one step
Immunochromatographic
Qualitative test .
The assay provides a simple
and rapid analytical
screening procedure to
detect different abuse drug
in human urine	Monitect Drug Screen
Cassette Assay ( K004034)
and GC/MS
Monitect Multiple Drug
Screen
immunochromatographic
assay for qualitative
determination of the
presence of different drug in
human urine.	Instant-View Propoxyphens
Urine test(K022915) and
GC/MS
Instant View Drug Screen
Immunochromatographic
Assay for qualitative
Determination of the
presence of Propoxyphene
In human urine.
Analytes	Amphetamine,
Methamphetamine,
Benzoylecgonine,
Benzodiazepine, Marijuana,
Morphine, Phencyclidine,
Methadone , Oxycodone ,
Tricyclic Antidepressant,
Barbiturates and
Propoxyphene	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

3

| Device
Characteristics | Subject Device | Predicate Device(s)
Monitect Drug Screen
Cassette Assay ( K004034)
and GC/MS | Predicate Device(S)
Instant-View Propoxyphens
Urine test(K022915) and
GC/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 of
Reagent | None | None | None |
| Storage | Below 28 °C until expiration | 15°C - 30°C until expiration date | 15°C — 30 °C until
expiration 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.

4

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).

5

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

6

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 metabolites
to 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 |
| Tricyclic
Antidepressant | Nortriptyline Hydrochloride
Secobarbital | 1000 |
| Barbiturates
Propoxyphene | | 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