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510(k) Data Aggregation
(189 days)
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.
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. 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.
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. It is for prescription use.
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.
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.
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