(222 days)
Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.
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.
New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device 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 device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen 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. 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.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the "Forsure One Step Multiple (Up to Six) Drug Screen Test Card":
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics. However, the implicit acceptance criteria are that the device is "substantially equivalent" to predicate devices (Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP and GC/MS) for the qualitative determination of specific drugs at defined cut-off concentrations in human urine. The "reported device performance" is the claim of substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Qualitative determination of: | Forsure One Step Multiple Drug Screen Test Card |
| Amphetamine at 1000 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Methamphetamine at 1000 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| THC at 50 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Morphine at 2000 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Benzoylecgonine at 300 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Phencyclidine at 25 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Functioning as a rapid analytical screening procedure | Functioning as a rapid analytical screening procedure |
| Requiring a more specific alternate chemical method (like GC/MS) for confirmation | Explicitly states: "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." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not report specific sample sizes for a test set used to evaluate the Forsure One Step Multiple Drug Screen Test Card. It describes the device and claims substantial equivalence to predicate devices and GC/MS, implying that performance data was collected to justify this claim, but the details of such a study (sample size, data provenance like country of origin, retrospective/prospective) are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth for confirming results is stated to be Gas Chromatography/Mass Spectrometry (GC/MS).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set. This type of device relies on a chemical "ground truth" (GC/MS) rather than expert consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable to the described device. The Forsure One Step Multiple Drug Screen Test Card is a qualitative immunoassay device, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies with human readers would typically be conducted. There is no mention of AI or human-in-the-loop assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of an immunoassay test with visual interpretation. The device's performance is inherently standalone in the sense that the test strip itself produces the result (presence/absence of a line), which is then visually interpreted. There is no complex algorithm involved in 'standalone' performance as understood in AI-driven diagnostics.
7. The Type of Ground Truth Used
The primary ground truth explicitly mentioned for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical method used to identify and quantify substances in a sample, making it a robust reference standard for drug testing.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. As an immunoassay device, it does not involve machine learning or AI that would typically require a "training set" in the computational sense. The device's components and assays are developed based on chemical and biological principles, not statistical training data.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, this question is not applicable. The underlying scientific principles and calibration of the immunoassay are established through chemical and biological validation, rather than a data-driven training process with established ground truth.
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March 30th, 2005 SECTION II 510(k) SUMMARY
APR 2 4 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.
052520 510{k) Number:
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) 602-2929 Facsimile: (760) 602-2999
Preparation Date:
May 30, 2005
Device Information:
Device Classification Name: Immunoassay, Amphetamine, Methamphetamine, Benzoylecgonine, 11-nor-A-9-THC-9-COOH , Morphine, Phencyclidine. Common/Usual Name: Immunoassay Test System for detection of Multiple Drug (up to 6) Screen Test Device in Human Urine Proprietary Name: Rapid Forsure One Step Multiple Drug ( up tp 6 ) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC, Morphine and Phencyclifice Test
Regulation Number: 21 CFR§862.3650 Regulatory Name: Amphetamine, Methamphetamine, Benzoylecgonine, THC Morphine and Phencyclidine test system Product Code: DJG Regulatory Class: Class II
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Predicate Devices:
Rapid One Step Strip Buprenorphine Test is substantially equivalent to Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP of Branan Medical Corporation, cleared by FDA( K004034), and GC/MS for its stated intended use.
Device Description:
New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device 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 device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen 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. 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 and Multiple Drug screen Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine Cassette Test 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. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine 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.
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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) |
|---|---|---|
| Intended Use | Forsure Multiple Drug Screen onestep ImmunochromatographicQualitative test.The assay provides a simple andrapid analytical screeningprocedure to detect up to sixdifferent abuse drug(Amphetamine,Methamphetamine,Benzoylegconine, THC,Morphine,and Phencyclidine) inhuman urine | Monitect Drug ScreenCassette Assay ( K004034)and GC/MSMonitect Multiple DrugScreenimmunochromatographicassay for qualitativedetermination of thepresence of up to fivedifferent drug(Amphetamine,Methamphetamine, THC,Benzoylecgonine,Phencyclidine in humanurine. |
| AnalyteCutoff | Amp,Mamp,BEG,THC,MOR,PCPAmp;1000 ng/ml,Mamp:1000 ng/ml,BEG :300 ng/ml,THC: 50 ng/ml.MOR; 2000 ng/ml.PCP :25 ng/ml. | AMP,Mamp,BEG,THC,PCPAmp: 1000 ng/ml,Mamp;1000ng/mlBEG; 300 ng/mlTHC ; 50 ng/mlPCP ; 25 ng/ml |
| Matrix | Urine | Urine |
| Calibrator | None | None |
| Instrument | None, Visual read single use | None, Visual Read singleuse |
| Calibration of Reagent | None | None |
| Storage | Below 28 °C until expiration | 15°C - 30°C until expirationdate |
Summary:
The information provided in this pre-market notification demonstrates that Forsure Rapid One Step Multiple up to six Drug Screen Test Device is substantially equivalent to Branan's Monitect Drug Screen Cassette Test system 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 Multiple Rapid One Step Drug Screen Test is safe and effective for its stated interded use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized emblem with three curved lines, resembling a person embracing another. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlic New Product Development Director Aventir Biotech, LLC. 3108 Avenida Olmeda Carlsbad, CA 92009
APR 2 4 2006
Re: K052520
Trade/Device Name: Forsure One Step Multiple (Up to Six) Drug Screen Test Card for Amphetamine, Methamphetamine, Bezoylecgonine, 11-nor-A-9 Tetrahydrocannabinal-9-carboxylic acid, Morphine and Phencyclidine. Regulation Number: 21 CFR8862.3100 Regulation Namc: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJC, DJC, DPK, LDJ, LCM Dated: April 18, 2006 Received: April 19, 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 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 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 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 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 Guti
Alberto Guticarez, 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): K052520
Device Name:
Forsure One Step Multiple (Up to Six) Drug Screen Test Card for Amphetamine, Methamphetamine, Bezoylecgonine, 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid, Morphine and Phencyclidine.
Indications for Use:
Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.
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.
Prescription Use (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)
C.C.
Sign-Off
Diagnostic
Evaluation and Safety
Page 1 of 1
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).