Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels:

Test: Amphetamine, Calibrator: D-Amphetamine, Cutoff: 1000 ng/ml
Test: Methamphetamine, Calibrator: D-Methamphetamine, Cutoff: 1000 ng/ml
Test: Benzodiazepine, Calibrator: Oxazepam, Cutoff: 300 ng/ml
Test: Barbiturate, Calibrator: Secobarbital, Cutoff: 300 ng/ml
Test: Cocaine, Calibrator: Benzoylecgonine, Cutoff: 300 ng/ml
Test: Cannabinoids, Calibrator: 11-nor-delta9-THC-9 COOH, Cutoff: 50 ng/ml
Test: Opiates, Calibrator: Morphine, Cutoff: 2000 ng/ml
Test: Phencyclidine, Calibrator: Phencyclidine, Cutoff: 25 ng/ml
Test: Methadone, Calibrator: Methadone, Cutoff: 300 ng/ml
Test: Oxycodone, Calibrator: Oxycodone, Cutoff: 100 ng/ml
Test: Tricyclic Antidepressant, Calibrator: Nortriptyline, Cutoff: 1000 ng/ml
Test: Propoxyphene, Calibrator: Propoxyphene, Cutoff: 300 ng/ml

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Device Description

Forsure One Step Dip & Read Drug Screen Test 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 PRELIMINARY 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, K061617, describes a 510(k) summary for the Forsure One Step Dip & Read Drug Screen Test. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for training sets is not available in the provided text.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device's ability to detect various drugs at specific cutoff concentrations. While it doesn't explicitly state "acceptance criteria" for a study, these cutoff concentrations define the required performance level for qualitative determination. The "reported device performance" is implicitly that the device does detect these drugs at or above these cutoffs, as demonstrated by its substantial equivalence claim.

Drug	Cutoff Concentration (Acceptance Criteria)	Reported Device Performance
Amphetamine	1000 ng/ml	Detects at/above cutoff
Methamphetamine	1000 ng/ml	Detects at/above cutoff
Benzoylecgonine (Cocaine)	300 ng/ml	Detects at/above cutoff
Benzodiazepine	300 ng/ml	Detects at/above cutoff
Marijuana (THC)	50 ng/ml	Detects at/above cutoff
Morphine (Opiates)	2000 ng/ml	Detects at/above cutoff
Phencyclidine	25 ng/ml	Detects at/above cutoff
Methadone	300 ng/ml	Detects at/above cutoff
Oxycodone	100 ng/ml	Detects at/above cutoff
Tricyclic Antidepressant	1000 ng/ml	Detects at/above cutoff
Barbiturates	300 ng/ml	Detects at/above cutoff
Propoxyphene	300 ng/ml	Detects at/above cutoff

Note: The reported device performance is inferred from the statement that the device is "safe and effective for its stated intended use" and "substantially equivalent" to predicate devices, which implies it meets these detection thresholds. No specific sensitivity/specificity, accuracy rates, or detailed concordance percentages are provided for each drug in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. It is a submission from Tianjin New Bay Bioresearch Co., Ltd., China, but this does not confirm the origin of any test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/not specified. The "ground truth" for drug detection is typically established using a reference chemical method, not human experts in this context.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. The confirmation method mentioned is Gas Chromatography/mass spectrometry (GC/MS).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, an MRMC comparative effectiveness study is not relevant for this type of in-vitro diagnostic device that provides a visual "dip & read" result. The "read" aspect is direct observation of color bands, not interpretation that would require multiple human readers and comparison with AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Was a standalone study done? Yes, the device itself is a "standalone" test. It's an "algorithm only" in the sense that it relies on a chemical reaction to produce a visual result without requiring human interpretation for its primary function. The performance is intrinsically "standalone" as it's a test strip read visually by a single user. The described mechanism ("produces a magenta color band... no color band") indicates a direct chemical outcome.

7. Type of Ground Truth Used

Type of Ground Truth: 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." This indicates that GC/MS is the gold standard used to establish the true presence or absence of drugs, serving as the ground truth.

8. Sample Size for the Training Set

Sample Size: Not specified in the provided text. As this is an immunoassay device, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance validation for such devices generally involves testing a range of known positive and negative samples, and samples spiked at or around the cutoff.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: As above, GC/MS would be the method for establishing the true concentration of drugs in samples used for any validation or "training-like" processes (e.g., cutoff calibration, cross-reactivity studies) for an immunoassay. However, the document does not detail specific "training set" procedures or how their ground truth was established.

Summary

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K061617

SECTION II 510(k) SUMMARY

NOV 2 2 2006

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: Designed K #: K061617

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:

May 18, 2006

Device Information:

Device Classification Name:

Immunoassay of Amphetamine, Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, Benzodiazepine, Barbiturates, Marijuana. Methadone , Oxycodone , Tricyclic Antidepressants and Propoxyphene.

Common/Usual Name: Immunoassay Test System for Detection of Single and Multiple Dip & Read Abuse Drug Screen Test Device in Human Urine.

Proprietary Name: Forsure One Step Dip & Read Drug Screen Test for Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone, Tricyclic Antidepressants, Barbiturates and Propoxyphene.

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Regulation Number:

21CFR862.3100, Amphetamine Test System 21CFR862.3150, Barbiturate Test System 21CFR862.3170, Benzodiazepine Test System 21CFR862.3250, Cocaine and Cocaine Metabolite Test System 21CFR862.3610, Methamphetamine Test System 21CFR862.3620, Methadone Test System 21CFR862.3650, Opiates and Test System (includes Oxycodone) 21CFR862.3700, Propoxyphene Test System 21CFR862.3870, Cannabinoids Test System 21CFR862.3910, Tricyclic Antidepressant Unclassified, Phencyclidine

Regulatory Name:

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

Product Code: DKZ, DIS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM

Regulatory Class: Class II

Predicate Devices:

Forsure One Step Dip & Read Drug Screen Test Device is substantially equivalent to UCP Bioscience Rapid Drug Screening Test Strips cleared by FDA (K050540), or TNB Forsure One Step Drug Screen Test Cup Device cleared by FDA (K052882) and GC/MS for its stated intended use.

Device Description:

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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:

Forsure One Step Dip & Read Drug Screen Test 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 Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Comparison to Predicate Device(s):

Forsure One Step Dip & Read Drug Screen Test is substantially equivalent to UCP Rapid Drug Screening Test strips system cleared by FDA, e.g., the Assay (K050540) or TNB Forsure One Step Drug Screen Test Cup Device urine test ( K 052882 ) and GC/MS for its stated intended use.

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DeviceCharacteristics	Subject Device	Predicate Devicce(s)UCPDrug Screening TestStrip ( K050540)	Predicate Devicce(s) ForsureOne Step Drug Screen TestCup Device ( K052882)
Intended Use	The assay provides asimple and rapidanalytical screeningprocedure to qualitativedetermination of differentabuse drug in humanurine	UCP Multiple Drug Screenassay for qualitativedetermination of thepresence of different drugin human urine.	For qualitative determinationOf the presence of differentdrug in 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, andBarbiturates	Amphetamine,Methamphetamine,Benzoylecgonine,Benzodiazepine, Marijuana,Morphine, Phencyclidine,Methadone, Oxycodone,Tricyclic Antidepressant,Barbiturates and 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,BAR: 300ng/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,BAR: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,BAR:300 ng/ml,TCA:1000 ng/ml,PPX:300 ng/ml.
Test Principle	Immunochromatographic,Lateral Flow	Immunochromatographic,Lateral Flow	Immunochromatographic,Lateral Flow
Matrix	Urine	Urine	Urine
Calibrator	None	None	None
Instrument	None, Visual read singleuse	None, Visual Read singleuse	None, Visual Read single use
Calibration ofReagent	None	None	None
Storage	Below 28 °C untilexpiration	15°C - 30°C untilexpiration date	Below 28 °C until expiration

Summary:

The information provided in this pre-market notification demonstrates that Forsure One Step Dip & Read Drug Screen Test is substantially equivalent to UCP Ravid Drug Screening Test strips system, TNB One Step Drug Screen Test Cup Device 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 One Step Dip & Read Drug Screen Test is safe and effective for its stated intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 2 2 2006

Re: K061617 Trade/Device Name: Forsure Onc Step Dip & Read Drug Screen Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM Dated: September 26, 2006 Received: September 28, 2006

Dear Mr. Berlie:

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 cither 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).

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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 logally 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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Alberto Gutt

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

510(k) Number (if known): K061617

Device Name: Forsure One Step Dip & Read Drug Screen Test

Indications for Use:

Test	Calibrator	Cutoff
Amphetamine	D-Amphetamine	1000 ng/ml
Methamphetamine	D-Methamphetamine	1000 ng/ml
Benzodiazepine	Oxazepam	300 ng/ml
Barbiturate	Secobarbital	300 ng/ml
Cocaine	Benzoylecgonine	300 ng/ml
Cannabinoids	11-nor-Δ9-THC-9 COOH	50 ng/ml
Opiates	Morphine	2000 ng/ml
Phencyclidine	Phencyclidine	25 ng/ml
Methadone	Methadone	300 ng/ml
Oxycodone	Oxycodone	100 ng/ml
Tricyclic Antidepressant	Nortriptyline	1000 ng/ml
Propoxyphene	Propoxyphene	300 ng/ml

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device
Evaluation and Safety

K041617
510(k)

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).