FIRST SIGN DRUG OF ABUSE SCREENING TEST
Device Facts
| Record ID | K032575 |
|---|---|
| Device Name | FIRST SIGN DRUG OF ABUSE SCREENING TEST |
| Applicant | W.H.P.M., Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | May 19, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: Compound Abbreviation Level Amphetamine (d-amphetamine sulfate) AMP 1000 ng/ml Methamphetamine ((+)methamphetamine HC1) METH 1000 ng/ml Opiates 2000 (morphine-3-P-D glucuronide) OPI 2000 ng/ml Opiates 300 (morphine-3-P-D glucuronide) OPI 300 ng/ml Cocaine (Benzoylecgonine) COC 300 ng/ml Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) THC 50 ng/ml Phencyclidine (phencyclidine HC1) PCP 25 ng/ml First Sign™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained. For professional use only.
Device Story
Lateral flow immunoassay for qualitative detection of drugs of abuse in urine; detects AMP, METH, OPI, COC, THC, and PCP at specified cutoff levels. Device used by professionals in clinical settings; provides preliminary results. Requires confirmation via GC/MS for clinical decision-making. Benefits include rapid screening for substance abuse.
Clinical Evidence
No clinical trials performed. Evidence consists of analytical performance studies including precision/reproducibility (n=40 per concentration), cutoff verification (n=10 per concentration), and analytical specificity/cross-reactivity. Method comparison studies were conducted using clinical and spiked urine samples compared against GC/MS and predicate devices, showing high agreement (>94% across all analytes).
Technological Characteristics
Lateral flow immunochromatographic assay. Components: dye pad with colloidal gold particles coated with mouse monoclonal antibody; test line with drug-protein conjugates; control line with goat polyclonal antibody. Visual readout. Single-use, standalone device. No electronic components or software.
Indications for Use
Indicated for professional use in the qualitative detection of drugs of abuse (Amphetamine, Methamphetamine, Opiates, Cocaine, Cannabinoids, Phencyclidine) in human urine at SAMHSA-recommended cutoff levels.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- Acon Rapid Drug Screens
Related Devices
- K022388 — STARTOX DRUG OF ABUSE SCREENING TEST (4) · Starplex Scientific, Inc. · Feb 27, 2003
- K980153 — DRUG CHECK · Texas Immunology, Inc. · Mar 27, 1998
- K021006 — STARTOX DRUG OF ABUSE SCREENING TEST · Starplex Scientific, Inc. · Jun 10, 2002
- K980865 — QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 · Phamatech · Apr 1, 1998
- K980872 — RAPID DRUG SCREEN' 8 PANEL · American Bio Medica Corp. · Mar 20, 1998
Submission Summary (Full Text)
{0}
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K032575
B. Analyte:
Amphetamine, Methamphetamine, Opiates, Cocaine, Cannabinoids, Phencyclidine
C. Type of Test:
Qualitative immunoassay
D. Applicant:
W.H.P.M. Inc.
E. Proprietary and Established Names:
First Sigh Drug Screening Tests
F. Regulatory Information:
1. Regulation section:
21 CFR § 862.31000 Amphetamine Test System; 21 CFR § 862.3610
Methamphetamine Test System; 21 CFR § 862.3650 Opiate Test System; 21
CFR § 862.3250 Cocaine and Cocaine metabolite Test System; 21 CFR § 862.3870 Cannabinoid Test System; Phencyclidine Enzyme Immunoassay
2. Classification:
Class II
3. Product Code:
DKZ; DJC; DJG; DIO; DKE; LCM
4. Panel:
Toxicology (91)
G. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
First Sign Drugs of Abuse Screening Tests are one-step lateral flow
immunoassay intended for the detection of drug analytes in urine. First Sign
Drugs of Abuse Screening Test are intended for use in the qualitative
detection of drugs of abuse at the following Substance Abuse Mental Health
Services Administration (SAMHSA) recommended levels:
{1}
2
| Amphetamine | 1000 ng/ml |
| --- | --- |
| Methamphetamine: | 1000 ng/ml |
| Cocaine: | 300 ng/ml |
| Cannabinoids: | 50 ng/ml |
| Phencyclidine: | 25 ng/ml |
| Opiates2000: | 2000 ng/ml |
| Opiates300: | 300 ng/ml |
First Sign Drugs of Abuse Screening Tests provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are used.
For professional use only.
3. Special condition for use statement(s):
These assays provide only the preliminary analytical test results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
4. Special instrument Requirements:
Not applicable. The devices are visually read single-use devices.
H. Device Description:
The First Sign Drugs of Abuse Screening Tests are immunoassays based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
Labeled antibody-dye conjugate mixes sample specimen and binds to the free drug present forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the test zone preventing the formation of pink-rose color band when drug concentration in the specimen is above the cut-off concentration. Unbound dye conjugates bind to the reagent in the negative control zone and produces a pink-rose color band, demonstrating that the reagents and device are functioning correctly.
A negative specimen produces two distinct color bands in both the test region and the control region. A positive specimen produces only one color band in the control region.
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.
{2}
3
I. Substantial Equivalence Information:
1. Predicate device name(s):
ACON AMP One Step Amphetamine Test Strip; ACON mAMP One Step Methamphetamine Test Strip; ACON COC One Step Cocaine Test Strip; ACON OPI One Step Opiate Test Strip; ACON THC One Step Marijuana Test Strip; ACON PCP One Step Phencyclidine Test Strip
2. Predicate K number(s):
K011673; K011672; K010841; K013380; k003557; K011730
3. Comparison with predicate:
The devices and their predicates are for the qualitative determination of the same analyte(s) in the same matrix, and utilize the same cutoff concentrations. All are visually-read single use devices.
J. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in this submission.
K. Test Principle:
The tests employ lateral flow immunochromatographic technology.
Drug in the sample and drug-labeled conjugate (containing a chromagen) compete for antibody binding sites in the test area of the test strip. Binding of drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator.
The devices also have an internal process controls which indicate that adequate volume of sample has been added and that the immunochromatographic strip is intact.
The test line contains a membrane striped and coated with drug-protein conjugates on the test strip. A goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with a mouse monoclonal antibody specific to the test drug.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, drug-free urine to give the appropriate concentration. Each specimen, at each concentration of analyte, was tested four times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration. The data are summarized below:
{3}
4
Amphetamine
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 500 | 40 | 40 negative | >99% |
| 750 | 40 | 40 negative | >99% |
| 1000 | 40 | 40 positive | >99% |
| 1500 | 40 | 40 positive | >99% |
Cocaine
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 150 | 40 | 40 negative | >99% |
| 225 | 40 | 40 negative | >99% |
| 300 | 40 | 40 positive | >99% |
| 375 | 40 | 40 positive | >99% |
| 450 | 40 | 40 positive | >99% |
Methamphetamine
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 500 | 40 | 40 negative | >99% |
| 750 | 40 | 40 negative | >99% |
| 1000 | 40 | 40 positive | >99% |
| 1500 | 40 | 40 positive | >99% |
Opiate 300
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 150 | 40 | 40 negative | >99% |
| 225 | 40 | 40 negative | >99% |
| 300 | 40 | 40 positive | >99% |
| 375 | 40 | 40 positive | >99% |
{4}
5
Opiate 2000
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 1000 | 40 | 40 negative | >99% |
| 1500 | 40 | 40 negative | >99% |
| 2000 | 40 | 40 positive | >99% |
| 3000 | 40 | 40 positive | >99% |
Phencyclidine
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 12.5 | 40 | 40 negative | >99% |
| 19 | 40 | 40 negative | >99% |
| 25 | 40 | 40 positive | >99% |
| 37.5 | 40 | 40 positive | >99% |
Marijuana
| Concentration (ng/ml) | Total number of Determinations | Result | Precision |
| --- | --- | --- | --- |
| 0 | 40 | 40 negative | >99% |
| 25 | 40 | 40 negative | >99% |
| 37.5 | 40 | 40 negative | >99% |
| 50 | 40 | 40 positive | >99% |
| 75 | 40 | 40 positive | >99% |
b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.
c. Traceability (controls, calibrators, or method):
Procedural controls are included in the test strip and device. A color line appearing in the control region is considered as an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with these kits; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper
{5}
test performance. Users should follow local, state, and federal guidelines for testing QC materials.
d. Cutoff Studies:
Know concentrations of drug were added to normal, drug free urine. Ten (10) determinations were made at each serial dilution of the single analyte. Cut-off is defined as that concentration which produced positive responses in all replicates. The data are summarized below:
Amphetamine
| Samples | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | | | | | | | | | | |
| 0 | - | - | - | - | - | - | - | - | - | - |
| 500 | - | - | - | - | - | - | - | - | - | - |
| 750 | - | - | - | - | - | - | - | - | - | - |
| 1000 | + | + | + | + | + | + | + | + | + | + |
| 1500 | + | + | + | + | + | + | + | + | + | + |
Cocaine
| Samples | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | | | | | | | | | | |
| 0 | - | - | - | - | - | - | - | - | - | - |
| 150 | - | - | - | - | - | - | - | - | - | - |
| 225 | - | - | - | - | - | - | - | - | - | - |
| 300 | + | + | + | + | + | + | + | + | + | + |
| 375 | + | + | + | + | + | + | + | + | + | + |
| 450 | + | + | + | + | + | + | + | + | + | + |
Methamphetamine
| Samples | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | | | | | | | | | | |
| 0 | - | - | - | - | - | - | - | - | - | - |
| 500 | - | - | - | - | - | - | - | - | - | - |
| 750 | - | - | - | - | - | - | - | - | - | - |
| 1000 | + | + | + | + | + | + | + | + | + | + |
| 1500 | + | + | + | + | + | + | + | + | + | + |
Opiate 2000
| Samples | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | | | | | | | | | | |
| 0 | - | - | - | - | - | - | - | - | - | - |
| 1000 | - | - | - | - | - | - | - | - | - | - |
| 1500 | - | - | - | - | - | - | - | - | - | - |
| 2000 | + | + | + | + | + | + | + | + | + | + |
| 3000 | + | + | + | + | + | + | + | + | + | + |
{6}
7
Phencyclidine
| Samples | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | | | | | | | | | | |
| 0 | - | - | - | - | - | - | - | - | - | - |
| 12.5 | - | - | - | - | - | - | - | - | - | - |
| 19 | - | - | - | - | - | - | - | - | - | - |
| 25 | + | + | + | + | + | + | + | + | + | + |
| 37.5 | + | + | + | + | + | + | + | + | + | + |
Marijuana
| Samples | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Concentration (ng/ml) | | | | | | | | | | |
| 0 | - | - | - | - | - | - | - | - | - | - |
| 25 | - | - | - | - | - | - | - | - | - | - |
| 37.5 | - | - | - | - | - | - | - | - | - | - |
| 50 | + | + | + | + | + | + | + | + | + | + |
| 75 | + | + | + | + | + | + | + | + | + | + |
e. Analytical specificity:
Interference and cross reactivity studies were performed by testing the drug analytes in the First Sign Drugs Screening Tests with various other drugs. Below is a list of drugs that will give a positive result at or above the concentration stated. All the following drugs were added to normal, drug free urine.
Amphetamine
| Drug Compound | Response equivalent to cutoff in ng/ml |
| --- | --- |
| d-amphetamine | 1,000 |
| D,l-amphetamine | 1,000 |
| l-amphetamine | 20,000 |
| Phentermine | 1,250 |
| (+/-)Methylenedioxyamphetamine (MDA) | 1,500 |
Methamphetamine
| Drug Compound | Response equivalent to cutoff in ng/ml |
| --- | --- |
| Procaine (Novocaine) | 60,000 |
| Trimethobenzamine | 20,000 |
| +/-methamphetamine | 1,000 |
| +methamphetamine | 500 |
| 3,4-Methylenedioxyethylamphetamine(MDEA) | 20,000 |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 2,500 |
| Ranitidine (Zantac) | 50,000 |
{7}
8
Opiates 300
| Drug compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| 6-acetylmorphine | 500 |
| Codeine | 100 |
| Heroin | 500 |
| Hydrocodone | 1,250 |
| Hydromorphone | 2,000 |
| Oxycodone | 75,000 |
| Morphine | 300 |
| Morphine-3-β-glucuronide | 75 |
| Ethylmorphine | 100 |
| Thebaine | 13,000 |
| Eserine (Physosotigmine) | 15,000 |
Opiates 2000
| Drug compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| 6-acetylmorphine | 1,000 |
| Codeine | 800 |
| Heroin | 400 |
| Hydrocodone | 10,000 |
| Hydromorphone | 2,000 |
| Oxycodone | 5,000 |
| Morphine | 1,600 |
| Morphine-3-β-glucuronide | 1,000 |
| Ethylmorphine | 50,000 |
| Thebaine | 26,000 |
Cocaine
| Compound | Response equivalent to cutoff in ng/ml |
| --- | --- |
| Benzoylecogonine | 300 |
| Cocaethylene | 300 |
| Cocaine | 300 |
| Metoclopromide | 80,000 |
| procaine | 75,000 |
Cannabinoids (THC)
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| 11-Hydroxy-Δ⁹-Tetrahydrocannabinol | 5,000 |
| 11-Nor-Δ⁸-Tetrahydrocannabinol | 50 |
| 11-Nor-Δ⁹-Tetrahydrocannabinol Glucuronide | 2,5000 |
| Δ⁸-Tetrahydrocannabinol | 20,000 |
| Δ⁹-Tetrahydrocannabinol | 20,000 |
{8}
9
## Phencyclidine
| Compound | Response equivalent to cutoff in ng/ml |
| --- | --- |
| Phencyclidine | 25 |
| 4-hydroxyphencyclidine | 90 |
| Phencyclidine Morpholine | 625 |
## Cross-Reactivity
Studies were conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or dugs positive urine. The list of substances show no cross-reactivity when tested with the First Sign Drugs of Abuse Screening Test at a concentration of 100,000 ng/ml are listed in the package insert.
## f. Assay cut-off:
The First Sign Drugs Screening Test yield a positive result when the drug in urine exceed the specified drug concentrations. The recommended screening cutoff for listed drug positive specimens are the same as those set by the Substance Abuse and Mental Health Services Administration (SAMHSA). Characterization of how the device performs analytically around the claimed cutoff concentration appears in the Cutoff Studies Section, above.
## 2. Comparison studies:
### a. Method comparison with predicate device:
**Amphetamine:**
The First Sign Amphetamine Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon AMP Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
**All samples tested (clinical and spiked)**
| | First Sign | Predicate Device | Between - 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 79 | 79 | 0 | 38 | 43 | 100% |
| Negative | 80 | 80 | 67 | 2 | 0 | 97% |
**First Sign AMP comparison with ACON AMP Rapid Test-Spike Samples**
| Method | | ACON AMP Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign AMP | Results | Positive | Negative | |
| | Positive | 59 | 0 | 59 |
| | Negative | 0 | 61 | 61 |
| Total Results | | 59 | 61 | 120 |
| % Agreement | | 100% | 100% | 100% |
{9}
10
First Sign AMP comparison with GC/MS at cutoff 1000 ng/ml – Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign AMP | Results | Positive | Negative | |
| | Positive | 59 | 0 | 59 |
| | Negative | 1 | 60 | 61 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 98% | 100% | 99% |
First Sign AMP comparison with GC/MS – Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign AMP | Results | Positive | Negative | |
| | Positive | 20 | 0 | 20 |
| | Negative | 1 | 19 | 20 |
| Total Results | | 21 | 19 | 40 |
| % Agreement | | 95.2% | >99% | 97.5% |
Cocaine:
The First Sign Cocaine Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon COC Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
All samples tested (clinical and spiked)
| | First Sign | Predicate Device | Between – 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 88 | 86 | 2 | 56 | 30 | 98% |
| Negative | 72 | 74 | 58 | 1 | 1 | 97% |
First Sign comparison with ACON COC Rapid Test-Spike Samples
| Method | | ACON COC Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 59 | 2 | 61 |
| | Negative | 0 | 59 | 59 |
| Total Results | | 59 | 61 | 120 |
| % Agreement | | 100% | 97% | 98% |
First Sign comparison with GC/MS at cutoff 300 ng/ml – Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 59 | 2 | 61 |
| | Negative | 1 | 58 | 59 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 98% | 97% | 97% |
{10}
11
First Sign comparison with GC/MS at cutoff 300 ng/ml – Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 26 | 0 | 26 |
| | Negative | 1 | 13 | 14 |
| Total Results | | 27 | 13 | 40 |
| % Agreement | | 96.3% | >99% | 97.5% |
## Methamphetamine:
The First Sign Methamphetamine Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon mAMP Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
All samples tested (clinical and spiked)
| | First Sign | Predicate Device | Between – 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 82 | 83 | 0 | 30 | 52 | 100% |
| Negative | 78 | 77 | 58 | 4 | 0 | 94% |
First Sign comparison with ACON mAMP Rapid Test-Spike Samples
| Method | | ACON mAMP Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 57 | 0 | 57 |
| | Negative | 1 | 62 | 63 |
| Total Results | | 58 | 62 | 120 |
| % Agreement | | 98% | 100% | 99% |
First Sign comparison with GC/MS at cutoff 1000 ng/ml – Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 57 | 0 | 57 |
| | Negative | 3 | 60 | 63 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 95% | 100% | 97.5% |
First Sign comparison with GC/MS – Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 25 | 0 | 25 |
| | Negative | 1 | 14 | 15 |
| Total Results | | 26 | 14 | 40 |
| % Agreement | | 96.1% | >99% | 97.5% |
{11}
12
# Opiate:
The First Sign Morphine 300 Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon MOR Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
All samples tested (clinical and spiked)
| | First Sign | Predicate Device | Between - 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 85 | 85 | 0 | 48 | 37 | 100% |
| Negative | 75 | 75 | 41 | 1 | 0 | 98% |
First Sign AMP comparison with ACON MOR 300 Rapid Test-Spike Samples
| Method | | ACON Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 60 | 0 | 60 |
| | Negative | 0 | 60 | 60 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 100% | 100% | 100% |
First Sign comparison with GC/MS at cutoff 300 ng/ml - Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 60 | 0 | 60 |
| | Negative | 0 | 60 | 60 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 100% | 100% | 100% |
First Sign comparison with GC/MS - Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 25 | 0 | 25 |
| | Negative | 1 | 14 | 15 |
| Total Results | | 26 | 14 | 40 |
| % Agreement | | 96.1% | >99% | 97.5% |
# Morphine 2000
The First Sign Amphetamine Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon MOR Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
{12}
13
All samples tested (clinical and spiked)
| | First Sign | Predicate Device | Between – 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 70 | 70 | 1 | 33 | 36 | 99% |
| Negative | 90 | 90 | 61 | 0 | 0 | 100% |
First Sign comparison with ACON MOR 2000 Rapid Test-Spike Samples
| Method | | ACON MOR 2000 Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 60 | 0 | 60 |
| | Negative | 0 | 60 | 60 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 100% | 100% | 100% |
First Sign comparison with GC/MS at cutoff 2000 ng/ml – Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 60 | 0 | 60 |
| | Negative | 0 | 60 | 60 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 100% | 100% | 100% |
First Sign comparison with GC/MS at cutoff 2000 ng/ml– Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 9 | 1 | 10 |
| | Negative | 0 | 30 | 30 |
| Total Results | | 9 | 31 | 40 |
| % Agreement | | >99% | 96.8% | 97.5% |
Phencyclidine:
The First Sign Phencyclidine Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon PCP Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
All samples tested (clinical and spiked)
| | First Sign | Predicate Device | Between – 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 97 | 95 | 2 | 55 | 40 | 98% |
| Negative | 61 | 63 | 46 | 2 | 0 | 96% |
{13}
14
First Sign PCP comparison with ACON PCP Rapid Test-Spike Samples
| Method | | ACON PCP Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 60 | 2 | 62 |
| | Negative | 0 | 58 | 58 |
| Total Results | | 160 | 60 | 120 |
| % Agreement | | 100% | 97% | 98% |
First Sign PCP comparison with GC/MS at cutoff 25 ng/ml – Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 60 | 2 | 62 |
| | Negative | 0 | 56 | 58 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 100% | 97.5% | 98% |
First Sign comparison with GC/MS at cutoff 25 ng/ml – Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign | Results | Positive | Negative | |
| | Positive | 35 | 0 | 35 |
| | Negative | 2 | 1 | 3 |
| Total Results | | 37 | 1 | 38 |
| % Agreement | | 94.6% | >99% | 94.7% |
Marijuana:
The First Sign Marijuana Urine Screening Test was compared to GC/MS at the claimed cut-off levels. Additionally, the performance of the first Sign was compared to marketed device, Acon THC Rapid Test and reference method (GC/MS). A combination of clinical and spiked samples were tested. The following Tables provide a summary of test results.
All samples tested (clinical and spiked)
| | First Sign | Predicate Device | Between - 50% and cutoff | Between cutoff and + 50% | GC/MS Positive (> +50%) | % agreement with GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| Positive | 82 | 83 | 0 | 67 | 15 | 100% |
| Negative | 78 | 77 | 45 | 3 | 0 | 94% |
First Sign comparison with ACON THC Rapid Test-Spike Samples
| Method | | ACON THC Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign THC | Results | Positive | Negative | |
| | Positive | 58 | 0 | 58 |
| | Negative | 1 | 61 | 62 |
| Total Results | | 59 | 61 | 120 |
| % Agreement | | 98% | 100% | 99% |
{14}
15
First Sign comparison with GC/MS at cutoff 50 ng/ml – Spiked Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign THC | Results | Positive | Negative | |
| | Positive | 58 | 0 | 57 |
| | Negative | 2 | 60 | 63 |
| Total Results | | 60 | 60 | 120 |
| % Agreement | | 98% | 100% | 98% |
First Sign comparison with GC/MS at cutoff 50 ng/ml– Clinical Samples
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| First Sign THC | Results | Positive | Negative | |
| | Positive | 24 | 0 | 24 |
| | Negative | 1 | 15 | 15 |
| Total Results | | 25 | 15 | 40 |
| % Agreement | | 96.0% | >99% | 97.5% |
b. Matrix comparison:
Not applicable. The assay is intended for only one sample matrix.
3. Clinical studies:
a. Clinical sensitivity:
Not applicable. Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
M. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalent decision.
