First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/ MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/ MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.

For in vitro diagnostic use only. It is for prescription use.

First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Screen Test Cup can consist of any combination of the above listed drug analytes.

For in vitro diagnostic use only. It is for prescription use.

Device Description

The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card and First Sign Multi-Drug Screen Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The Dip Card kits contain a Dip Card device, a package insert and a urine cup for sample collection. The Cup kits contain a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

This document describes the performance of the "First Sign Multi-Drug Test Dip Card", "First Sign Multi-Drug Test Cup", "First Sign Multi-Drug Screen Test Dip Card", and "First Sign Multi-Drug Screen Test Cup" for detecting various drugs in human urine. The information provided focuses on the analytical and comparison studies, as clinical studies were deemed "Not applicable".

Here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner as a pre-defined threshold for device performance (e.g., "accuracy must be >95%"). Instead, it presents the results of performance studies, implicitly demonstrating that the device meets the expected performance for a qualitative drug test. The precision data shows a high degree of correct results at various concentrations relative to the cutoff, and the comparison studies show agreement with LC/MS.

Since explicit acceptance criteria are not provided in the document, the table will present the results as reported, highlighting the percentage of correct results near the cutoff for the "Lay-user study" as a key performance indicator. The precision studies, while not explicitly "acceptance criteria," demonstrate the device's reliability.

Table: Reported Device Performance (Summary from Precision and Lay-User Studies)

Study Type / Drug (Cut-off)	Concentration Relative to Cut-off	Reported Performance (Correct Results / Total)	Percentage of Correct Results	Notes
Precision Study (Propoxyphene 300 ng/mL)	Cut-off	Dip Card: 4-/46+ (Lot 1), 3-/47+ (Lot 2), 4-/46+ (Lot 3) Cup: 3-/47+ (Lot 1), 2-/48+ (Lot 2), 2-/48+ (Lot 3)	Dip Card: 92%, 94%, 92% Cup: 94%, 96%, 96%	This indicates that at the cutoff concentration, there were a few false negatives (e.g., 4 negative results out of 50 for Lot 1 Dip Card), and the remaining were positive. The device is designed to be qualitative, so this level of performance near the cutoff is acceptable for indicating presence. The +/- system indicates `Negative results / Positive results`.
Lay-User Study (AMP 500 ng/mL)	+25% Cut-off	19/20	95%	For samples at 25% above the cutoff, 95% of lay users correctly identified the positive result.
Lay-User Study (BAR 300 ng/mL)	+25% Cut-off	19/20	95%	Similar to AMP 500, 95% correct identification by lay users at +25% cutoff.
Lay-User Study (BZO 300 ng/mL)	+25% Cut-off	20/20	100%	All lay users correctly identified positive results.
Lay-User Study (BUP 10 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	For samples at 25% below the cutoff, 95% of lay users correctly identified the negative result. One false positive occurred.
Lay-User Study (COC 150 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	Similar to BUP 10, 95% correct identification by lay users at -25% cutoff. One false positive occurred.
Lay-User Study (EDDP 300 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	Similar, 95% correct identification at -25% cutoff. One false positive.
Lay-User Study (MDMA 500 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	Similar, 95% correct identification at -25% cutoff. One false positive.
Lay-User Study (MET 500 ng/mL)	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff. One false negative.
Lay-User Study (MOP 300 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff. One false positive.
Lay-User Study (MTD 300 ng/mL)	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff. One false negative.
Lay-User Study (OXY 100 ng/mL)	+25% Cut-off	20/20	100%	All lay users correctly identified positive results.
Lay-User Study (PCP 25 ng/mL)	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff. One false negative.
Lay-User Study (PPX 300 ng/mL)	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff. One false negative.
Lay-User Study (TCA 1000 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff. One false positive.
Lay-User Study (THC 50 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff. One false positive.
Lay-User Study (AMP 1000 ng/mL)	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff. One false positive.
Lay-User Study (BAR 300 ng/mL) - Config 2	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff for Configuration 2. One false positive.
Lay-User Study (BZO 300 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (BUP 10 ng/mL) - Config 2	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff for Configuration 2. One false positive.
Lay-User Study (COC 300 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (EDDP 300 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (MDMA 500 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (MET 1000 ng/mL) - Config 2	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff for Configuration 2. One false positive.
Lay-User Study (OPI 2000 ng/mL) - Config 2	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff for Configuration 2. One false positive.
Lay-User Study (MTD 300 ng/mL) - Config 2	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff for Configuration 2. One false positive.
Lay-User Study (OXY 100 ng/mL) - Config 2	-25% Cut-off	19/20 (Negative)	95%	95% correct identification by lay users at -25% cutoff for Configuration 2. One false positive.
Lay-User Study (PCP 25 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (PPX 300 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (TCA 1000 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.
Lay-User Study (THC 50 ng/mL) - Config 2	+25% Cut-off	19/20	95%	95% correct identification by lay users at +25% cutoff for Configuration 2. One false negative.

2. Sample sizes used for the test set and the data provenance:

Precision Study Test Set: For Propoxyphene (PPX), 50 tests were performed for each of 9 concentrations (from -100% to +100% cut-off) across 3 lots per device type (Dip Card and Cup). This means 50 tests * 9 concentrations * 3 lots * 2 device types = 2700 individual tests for Propoxyphene. The data for other drugs listed (AMP1000, COC300, THC, BUP, BAR, MOP 300, BZO, MET1000, MOP 2000, MTD, PCP, OXY, EDDP, MDMA, TCA, AMP 500, COC150, MET 500) were reported in previously cleared 510(k) submissions (e.g., K142353, K152551), suggesting similar study designs.
Comparison Studies (Clinical Samples) Test Set: 80 "unaltered clinical samples" (40 negative and 40 positive) were used for each drug. The document states this was done "for each device," implying this applies to both Dip Card and Cup formats, and for each drug analyte. These samples were "blind labeled."
Lay-User Study Test Set: 280 lay persons for each device format (Dip Card and Cup). Each participant received 1 blind-labeled sample and 1 device. The urine samples were prepared at 8 concentrations: negative, +/-25%, +/-50%, +/-75%, and -100% of the cutoff. The table for each drug shows 20 samples tested at each of these 8 concentrations. Therefore, for each drug analyte (e.g., AMP 500), 160 samples were tested (20 samples/concentration * 8 concentrations). As there are multiple drugs in each configuration, and multiple configurations, the total number of samples across all drugs and configurations tested by lay users would be substantial (e.g., for Configuration 1 which lists 14 drugs, 14 * 160 = 2240 samples for that configuration).
Data Provenance: Not explicitly stated in terms of country of origin. The comparison studies used "unaltered clinical samples," suggesting they were collected from human subjects. The precision and lay-user studies used "spiked drug in negative urine samples" or "drug free-pooled urine specimens" with added drugs. The studies appear to be quantitative laboratory performance studies rather than field studies with real patients. The document does not specify if the studies were retrospective or prospective, but the description ("prepared by spiking," "samples were tested," "were performed in-house") suggests prospective laboratory studies.

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)

Precision Study: "Each drug concentration was confirmed by LC/MS." LC/MS (Liquid Chromatography-Mass Spectrometry) is an analytical gold standard used for precise drug concentration determination. The "person who prepared the samples" was described as doing so "blindly," but there's no mention of "experts" in the context of interpretation, as LC/MS provides a quantitative, objective ground truth.
Comparison Studies (Clinical Samples): "The samples were blind labeled and compared to LC/MS results." Similar to the precision study, LC/MS serves as the gold standard for ground truth. The "three laboratory assistants" who ran the tests are operators of the device, not experts establishing the ground truth.
Lay-User Study: "The concentrations of the samples were confirmed by LC/MS." Again, LC/MS is the ground truth.

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

None. The ground truth in all studies (precision, comparison, lay-user) was established by LC/MS, which is an objective chemical analysis, not a subjective interpretation requiring human 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

No. This is an in vitro diagnostic device (IVD) for qualitative detection of drugs in urine. It is a rapid diagnostic test (likely a dip card or cup-based immunoassay), not an AI-assisted diagnostic tool that would involve human "readers" interpreting images or complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This device is a physical, lateral flow immunochromatographic assay. It does not have an "algorithm" in the sense of software running independently. Its "standalone" performance is represented by the analytical performance (precision, specificity, interference) and the comparison studies against the LC/MS gold standard, where the device's reading (line presence/absence) is directly compared to the LC/MS result. The "lay-user study" involved human interpretation of the device results (visual inspection of lines), which is the intended use, so it's a human-in-the-loop study in that sense, but not an "algorithm-only" study.

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

The ground truth for all studies was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is considered a highly accurate and quantitative analytical method for confirming drug concentrations in urine.

8. The sample size for the training set

This document describes a diagnostic test (immunoassay strip/cup), not an AI/ML device that typically requires a "training set." The device's underlying "knowledge" is built into the chemical reagents and physical design, not learned from data. Therefore, the concept of a "training set" for an algorithm is not applicable to this type of device. The extensive analytical studies serve to characterize its inherent performance.

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

As the device is not an AI/ML algorithm requiring a training set, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 12, 2021

W.H.P.M., Inc. % Joe Shia Manager LSI Consulting 504E Diamond Ave., Suite I Gaithersburg, Maryland 20877

Trade/Device Name: First Sign Multi-Drug Test Dip Card
First Sign Multi-Drug Test Cup
First Sign Multi-Drug Screen Test Dip Card
First Sign Multi-Drug Screen Test Cup
Regulation Number: 21 CFR 862.3700
Regulation Name: Propoxyphene Test System
Regulatory Class: Class II
Product Code: QBF, NGG, NFY, NFT, NFW, NFV, NGL, PTG, LCM, PTH, QAW
Dated: February 2, 2021
Received: February 4, 2021

Dear Joe Shia:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210327

Device Name

First Sign Multi-Drug Test Dip Card First Sign Multi-Drug Test Cup

Indications for Use (Describe)

First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1.5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.

Drug(Identifier)	Cut-off level
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL

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2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

For in vitro diagnostic use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Indications for Use

510(k) Number (if known)

K210327

Device Name

First Sign Multi-Drug Screen Test Dip Card First Sign Multi-Drug Screen Test Cup

Indications for Use (Describe)

Drug(Identifier)	Cut-off level

Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT)	300 ng/mL
Methamphetamine (MET)	1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000ng/mL or 300 ng/mL
Methadone (MDT)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.

For in vitro diagnostic use only. It is for prescription use.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	D.
Butalbital (BAR)	300 ng/mL
Buprenorphine (BUP)	10 ng/mL
Amphetamine (AMP)	1000ng/mL or 500 ng/mL
Drug(Identifier)	Cut-off level

{5}------------------------------------------------

Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300ng/mL or 150 ng/mL 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) 300 ng/mL 1000ng/mL or 500 ng/mL Methamphetamine (MET) Methylenedioxy-methamphetamine (MDMA) 500 ng/mL Morphine (MOP 300/OPI 2000) 2000ng/mL or 300 ng/mL Methadone (MDT) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL 300 ng/mL Propoxyphene (PPX) Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL

Configuration of the First Sign Multi-Drug Screen Test Cup combination of the above listed drug analytes.

For in vitro diagnostic use only. It is for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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{6}------------------------------------------------

510(k) SUMMARY K210327

August 10, 2021 1. Date: 2. Submitter: W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706
1. Contact person: Joe Shia LSI International Inc 504E Diamond Ave., Suite J Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com.
First Sign Multi-Drug Test Dip Card 4. Device Name: First Sign Multi-Drug Test Cup First Sign Multi-Drug Screen Test Dip Card First Sign Multi-Drug Screen Test Cup

Classification:
Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	862.3100, Amphetamine Test System	Toxicology
NGLBuprenorphine	II	862.3650, Opiate Test System	Toxicology
PTHSecobarbital	II	862.3150, Barbiturate Test System	Toxicology
NFVOxazepam	II	862.3170, Benzodiazepine Test System	Toxicology
NFYCocaine	II	862.3250, Cocaine Test System	Toxicology
PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	II	862.3620, Methadone Test System	Toxicology
NGGMethamphetamine	II	862.3610, Methamphetamine Test System	Toxicology
NGGMethylenedioxymethamphetamine	II	862.3610, Methamphetamine Test System	Toxicology
NGLMorphine	II	862.3650, Opiate Test System	Toxicology
PTGMethadone	II	862.3620, Methadone Test System	Toxicology
NGLOxycodone	II	862.3650, Opiate Test System	Toxicology
LCMPhencyclidine		Unclassified	Toxicology
QBFPropoxyphene	II	862.3700 Propoxyphene test system.	Toxicology

{7}------------------------------------------------

QAWNortriptyline	II	862.3910 Tricyclic antidepressantdrugs test system	Toxicology
NFWCannabinoids	II	862.3870, Cannabinoids TestSystem	Toxicology

1. Predicate Devices: K182701
  Wondfo T-Cup® Multi-Drug Urine Test Cup
1. Intended Use
  First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam. Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital,

{8}------------------------------------------------

Oxazepam. Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenvlpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL

{9}------------------------------------------------

Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only. It is for prescription use.

First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Butalbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL

{10}------------------------------------------------

Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

Configuration of the First Sign Multi-Drug Screen Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. It is for prescription use.

7. Device Description

1. Substantial Equivalence Information
  A summary comparison of features of the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup and the predicate devices is provided in following tables.

Table 1: Features Comparison of First Sign Multi-Drug Test Dip Card and the Predicate Devices

Item	Device	Predicate - K182701
Indication(s) for Use	For the qualitative determination of drugs of abuse in human urine.	Same
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/ml or 500 ng/mLOxazepam (BZO):300 ng/mlCocaine (COC): 300 ng/ml or 150 ng/mL11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/mlMethamphetamine (MET): 1,000 ng/ml or 500 ng/mLMorphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mLOxycodone (OXY) : 100 ng/mlButalbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/ml	Same

{11}------------------------------------------------

	Buprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine (MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP): 300 ng/mlPropoxyphene (PPX): 300 ng/ml
Methodology	Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Dip Card	Cup

	Table 2: Features Comparison of First Sign Multi-Drug Test Cup Tests and the Predicate
Devices

Item	Device	Predicate - K18270
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/ml or 500 ng/mLOxazepam (BZO):300 ng/mlCocaine (COC): 300 ng/ml or 150 ng/mL11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50ng/mlMethamphetamine (MET): 1,000 ng/ml or 500 ng/mLMorphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mLOxycodone (OXY): 100 ng/mlButalbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine (MDMA): 500ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine(EDDP): 300 ng/mlPropoxyphene (PPX): 300 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on the principleof antigen antibody immunochemistry.	Same
Type of Test	Qualitative	Same

{12}------------------------------------------------

Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Cup	Cup

Table 3: Features Comparison of First Sign Multi-Drug Screen Test Dip Card and the Predicate Devices

Item	Device	Predicate - K182701
Indication(s)for Use	For the qualitative determination of drugs of abuse in humanurine.	Same
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/ml or 500 ng/mLOxazepam (BZO):300 ng/mlCocaine (COC): 300 ng/ml or 150 ng/mL11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/mlMethamphetamine (MET): 1,000 ng/ml or 500 ng/mLMorphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mLOxycodone (OXY) : 100 ng/mlButalbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine (MDMA): 500ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP):300 ng/mlPropoxyphene (PPX): 300 ng/ml	Same
Methodology	Competitive binding, lateral flow immunochromatographicassays based on the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For prescription	For over-the-counter
Configurations	Dip Card	Cup

Table 4: Features Comparison of First Sign Multi-Drug Screen Test Cup Tests and the Predicate Devices

Item	Device	Predicate - K18270
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/ml or 500 ng/mLOxazepam (BZO):300 ng/mlCocaine (COC): 300 ng/ml or 150 ng/mL	Same

{13}------------------------------------------------

	11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml
	Methamphetamine (MET): 1,000 ng/ml or 500 ng/mL
	Morphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mL
	Oxycodone (OXY): 100 ng/ml
	Butalbital (BAR): 300 ng/ml
	Methadone (MTD): 300 ng/ml
	Buprenorphine (BUP): 10 ng/ml
	D,L-Methylenedioxymethamphetamine (MDMA): 500 ng/ml
	Phencyclidine (PCP): 25 ng/ml
	Nortriptyline (TCA): 1000 ng/ml
	2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine(EDDP): 300 ng/ml
	Propoxyphene (PPX): 300 ng/ml
	Competitive binding, lateral flowimmunochromatographic assays based on the principleof antigen antibody immunochemistry.
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on the principleof antigen antibody immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For prescription	For over-the-counter
Configurations	Cup	Cup

9. Test Principle

The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, and First Sign Multi-Drug Screen Test Cup are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine,

Methylenedioxymethamphetamine, Tricyclic Antidepressants, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off , +75% cut

{14}------------------------------------------------

off and +100% cut off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Propoxyphene. The data for AMP1000, COC300 and THC were reported in the cleared K142353. The data for BUP, BAR and MOP 300 were reported in the cleared K152551. The data for BZO, MET1000 and MOP 2000 were reported in the cleared K150162. The data for MTD, PCP and OXY were reported in the cleared K151441. The data for EDDP, MDMA and TCA were reported in the cleared K160793. The data for AMP 500, COC150 and MET 500 were reported in the cleared First Sign submission of K171695.

Propoxyphene

Dip Card
	Concentration byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber		0	80.7	165.5	248.1	339.9	416.8	497.2	558.1	677.3
Lot 1		50-/0+	50-/0+	50-/0+	50-/0+	4-/46+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2		50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3		50-/0+	50-/0+	50-/0+	50-/0+	4-/46+	50+/0-	50+/0-	50+/0-	50+/0-

Cup
Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
	0	80.7	165.5	248.1	339.9	416.8	497.2	558.1	677.3
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	3-/47+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	2-/48+	50+/0-	50+/0-	50+/0-	50+/0-

The cut-off value of 300ng/mL is verified for propoxyphene.

b. Linearity

Not applicable.

C. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50°C. Real time stability studies are ongoing.

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed between the Dip Card and the Cup formats.

Acetaminophen	ß-Estradiol	Oxalic acid
Acetophenetidin	Ethanol	Oxolinic acid
N-Acetylprocainamide	Erythromycin	Oxymetazoline

{15}------------------------------------------------

Acetylsalicylic acid	Fenoprofen	Papaverine
Albumin	Furosemide	Penicillin G
Aminopyrine	Gentisic acid	Perphenazine
Amoxicillin	Hemoglobin	Phenelzine
Ampicillin	Hydralazine	Prednisone
Apomorphine	Hydrochlorothiazide	(±)-Propranolol
Ascorbic acid	Hydrocortisone	Pseudoephedrine
Aspartame	O-Hydroxyhippuric acid	Quinine
Atropine	3-Hydroxytyramine	Ranitidine
Benzilic acid	Ibuprofen	Salicylic acid
Benzoic acid	Isoproterenol	Serotonin (5- Hydroxytyramine)
Bilirubin	Isoxsuprine	Sulfamethazine
Chloral hydrate	Ketamine	Sulindac
Chloramphenicol	Ketoprofen	Tetrahydrocortisone 3-(β-
		Dglucuronide)
Chlorothiazide	Labetalol	Tetrahydrocortisone 3-acetate
Chlorpromazine	Loperamide	Tetrahydrozoline
Cholesterol	Meperidine	Thiamine
Clonidine	Meprobamate	Thioridazine
Cortisone	Methoxyphenamine	Triamterene
(-)-Cotinine	Nalidixic acid	Trifluoperazine
Creatinine	Naloxone	Trimethoprim
Deoxycorticosterone	Naltrexone	DL-Tryptophan
Dextromethorphan	Naproxen	Tyramine
Diclofenac	Niacinamide	DL-Tyrosine
Diflunisal	Nifedipine	Uric acid
Digoxin	Norethindrone	Verapamil
Diphenhydramine	Noscapine	Zomepirac
Ecgonine methyl ester	(±)-Octopamine

e. Specificity

To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Propoxyphene. The data for AMP1000, COC300 and THC were reported in the cleared K142353. The data for BUP, BAR and MOP 300 were reported in the cleared K152551. The data for BZO, MET1000 and MOP 2000 were reported in the cleared K150162. The data for MTD, PCP and OXY were reported in the cleared K151441. The data for EDDP, MDMA and TCA were reported in the cleared K160793. The data for AMP 500, COC150 and MET 500 were reported in the cleared First Sign submission of K171695. There were no differences observed between the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.

Propoxyphene(Cut-off=300 ng/mL)	ResultPositive at(ng/ml)	%Cross-Reactivity
d-Propoxyphene	300	100%
Norpropoxyphene	1500	20%

{16}------------------------------------------------

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed between the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.

2. Comparison Studies

Method comparison studies for the First Sign Multi-Drug Test Dip Card and the First Sign Multi-Drug Test Cup were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Propoxyphene. The data for AMP1000, COC300 and THC were reported in the cleared K142353. The data for BUP, BAR and MOP 300 were reported in the cleared K152551. The data for BZO, MET1000 and MOP 2000 were reported in the cleared K150162. The data for MTD, PCP and OXY were reported in the cleared K151441. The data for EDDP, MDMA and TCA were reported in the cleared K160793. The data for AMP 500, COC150 and MET 500 were reported in the cleared First Sign submission of K171695.

Propoxyphene

Dip Card		Negative	Low Negative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	1	19	20
A	Negative	10	15	14	1	0
Viewer	Positive	0	0	1	20	20
B	Negative	10	15	14	0	0
Viewer	Positive	0	0	0	20	20
C	Negative	10	15	15	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	20200406-030	268.2	Positive
Viewer B	20200408-001	277.6	Positive
Viewer A	20200407-003	332.0	Negative

{17}------------------------------------------------

Cup		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	0	19	20
A	Negative	10	15	15	1	0
Viewer	Positive	0	0	1	20	20
B	Negative	10	15	14	0	0
Viewer	Positive	0	0	1	20	20
C	Negative	10	15	14	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	CupViewer Results
Viewer B	20200408-032	292.8	Positive
Viewer C	20200408-032	292.8	Positive
Viewer A	20200406-010	327.4	Negative

Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Typical Results are shown below.

First Sign Multi-Drug Test

Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150):

Assay	Results	Concentration
		-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
AMP 500	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	20	1	0	0
BAR 300	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of	100%	100%	100%	100%	95%	100%	100%
	correct results (%)
BZO 300	Negative	20	20	20	20	0	0	0
	Positive	0	0	0	0	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	100%	100%	100%
BUP 10	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
COC 150	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
EDDP 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
MDMA 500	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
MET 500	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
MOP 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
MTD 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	20	0	0	0
	Positive	0	0	0	0	20	20	20
OXY 100	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	100%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
PCP 25	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
PPX 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
TCA 1000	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
THC 50	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
Assay	Results	Concentration
		-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
AMP 1000	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
BAR 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
BZO 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
BUP 10	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
COC 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
EDDP 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	Negative	20	20	20	20	1	0	0
MDMA 500	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
	MET 1000	Negative	20	20	20	19	0	0
Positive		0	0	0	1	20	20	20
Total		20	20	20	20	20	20	20
Percentage ofcorrect results (%)		100%	100%	100%	95%	100%	100%	100%
OPI 2000	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
MTD 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
OXY 100	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
PCP 25	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
PPX 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ	100%	100%
TCA 1000	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ	100%	100%
THC 50	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો	100%	100%	100%

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Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300):

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Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies

Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card and First Sign Multi-Drug Screen Test Cup are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3700 Propoxyphene test system.

(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).