Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
Device Facts
| Record ID | K151348 |
|---|---|
| Device Name | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) |
| Applicant | Healgen Scientific,, LLC |
| Product Code | LFG · Clinical Toxicology |
| Decision Date | Aug 18, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3910 |
| Device Class | Class 2 |
Indications for Use
Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. 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 is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. 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 is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.
Device Story
Lateral flow immunochromatographic assays for qualitative detection of Propoxyphene, Nortriptyline, and EDDP in human urine; competitive binding principle using monoclonal mouse antibodies. Available in strip, cassette, dip card, and cup formats. Used in clinical or home settings by healthcare professionals or lay users. Urine sample migrates via capillary action; target drug competes with drug-conjugate for antibody binding sites. Absence of test line indicates drug presence above cutoff; presence of line indicates drug absence or concentration below cutoff. Control line confirms proper test performance. Results are preliminary; require GC/MS confirmation. Assists in identifying potential drug use; clinical judgment required for interpretation.
Clinical Evidence
Bench testing only. Precision studies (25 days, 3 operators) and method comparison studies (80 clinical samples vs GC/MS) performed. Lay-user study (n=1680) conducted across three sites with diverse demographics (ages 21->50) confirmed performance across all formats. Interference and specificity testing verified no cross-reactivity with common substances.
Technological Characteristics
Lateral flow chromatographic immunoassay; monoclonal anti-mouse antibody-dye conjugate with gold chloride; fixed drug-protein conjugates; anti-mouse IgG polyclonal antibody; visual readout; no instrumentation required; shelf life 24 months at 4-30°C.
Indications for Use
Indicated for qualitative detection of Propoxyphene (300 ng/mL), Nortriptyline (1000 ng/mL), and EDDP (300 ng/mL) in human urine. Intended for prescription and OTC use to provide preliminary screening results. Not for distinguishing between prescription use and abuse.
Regulatory Classification
Identification
A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). A tricyclic antidepressant drugs 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
- Co-Innovation Biotech One Step Single/Multi-drug Test (k140748)
Related Devices
- K152495 — Wondfo Propoxyphene Urine Test · Guangzhou Wondfo Biotech Co., Ltd. · Nov 23, 2015
- K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) · W.H.P.M., Inc. · Aug 17, 2016
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k151348
B. Purpose for Submission:
New device
C. Measurand:
Propoxyphene, Nortriptyline and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine)
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Healgen Scientific, LLC.
F. Proprietary and Established Names:
Healgen Propoxyphene Test, Healgen Nortriptyline Test, Healgen EDDP (Methadone Metabolite) Test
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JXN | Class II | 21 CFR 862.3700, Propoxyphene test system | Toxicology (91) |
| DJR | Class II | 21 CFR 862.3620, Methadone test system | Toxicology (91) |
| LFG | Class II | 21 CFR, 862.3910 Tricyclic antidepressant drugs Test System | Toxicology (91) |
H. Intended Use:
1. Intended use(s):
Refer to Indications for Use below
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2. Indication(s) for use:
Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.
Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when the prescription drug Nortriptyline is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.
Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.
3. Special conditions for use statement(s):
For over the counter (OTC) and prescription use.
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4. Special instrument requirements:
Not applicable. The device is a visually read single-use device.
I. Device Description:
Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP Test are immunochromatographic assays for Propoxyphene, Nortriptyline and EDDP. Each assay test is a lateral flow system for the qualitative detection of Propoxyphene, Nortriptyline and EDDP (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch. The test is intended for use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding confirmatory testing – the second step in the process is provided in the instructions for use.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Co-Innovation Biotech One Step Single/Multi drug Test
2. Predicate 510(k) number(s):
k140748
3. Comparison with predicate:
| Item | Healgen Propoxyphene Test (Candidate Device) | k140748 |
| --- | --- | --- |
| Intended Use | For the qualitative determination of Propoxyphene in human urine. | Same |
| Drug Analyte | Propoxyphene | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Cutoff Values | 300 ng/mL | Same |
| Intended Use Population | For over-the-counter and prescription uses. | Same |
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| Item | Healgen Propoxyphene Test (Candidate Device) | k140748 |
| --- | --- | --- |
| Configuration | Strip, Cassette, Dip Card, Cup | Cup |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Item | Healgen Nortriptyline Test (Candidate Device) | k140748 |
| --- | --- | --- |
| Intended Use | For the qualitative determination of Nortriptyline in human urine. | Same |
| Drug Analyte | Nortriptyline | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Cutoff Values | 1000 ng/mL | Same |
| Intended Use Population | For over-the-counter and prescription uses. | Same |
| Configuration | Strip, Cassette, Dip Card, Cup | Cup |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Item | Healgen EDDP Test (Candidate Device) | k140748 |
| --- | --- | --- |
| Intended Use | For the qualitative determination of EDDP in human urine. | Same |
| Drug Analyte | EDDP | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Cutoff Values | 300 ng/mL | Same |
| Intended Use Population | For over-the-counter and prescription uses. | Same |
| Configuration | Strip, Cassette, Dip Card, Cup | Cup |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
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K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP Test are rapid tests for the qualitative detection of Propoxyphene, Nortriptyline and EDDP in urine samples. Each assay test is a lateral flow chromatographic immunoassay. Each assay uses a monoclonal anti-mouse antibody -dye conjugate against the drugs containing gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in the test membranes.
When the absorbent end of the test is immersed into the urine specimen, the urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane. When sample drug levels are zero or below the target Cut-Off, antibody-dye conjugate binds to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored Test line that, regardless of its intensity, indicates a negative result.
When sample drug levels are at or above the target Cut-Off, the free drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly because of the antibody-dye conjugate binding to anti-mouse IgG immobilized in the Control Region(C) of the device.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
The precision performance of the Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP was evaluated using 3 lots for each format (Strip, Cassette, Cup, Dip Card) of the device by three operators. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format of devices. The testing consisted of analyzing samples in 2 runs per day for 25 days (n = 50 per lot) and by spiking drug free urine samples to achieve 100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off drug concentrations. Each drug concentration was confirmed by GC/MS. Results are summarized below for each lot and device.
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# Propoxyphene
Strip Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cassette Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CUP Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Nortriptyline
Strip Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Cassette Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CUP Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# EDDP
Strip Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cassette Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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# Dip Card Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# CUP Format
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## b. Linearity/assay reportable range:
Not applicable.
## c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control materials are not supplied with the devices; however, the package inserts list information on how to obtain control materials.
Stability protocols and acceptance criteria of all test formats were reviewed and deemed acceptable. The shelf life stability information supports the claimed shelf life of 24 months at 4 to 30 °C.
## d. Detection limit:
Not applicable.
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e. Analytical specificity:
Cross-reactivity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine. Samples were tested using three lots of each device for all formats. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross-reactivity of those compounds is listed below:
| Propoxyphene (Cut-off=300 ng/mL) | Result | % Cross-Reactivity |
| --- | --- | --- |
| Propoxyphene | Positive at 300 ng/mL | 100% |
| Norpropoxyphene | Positive at 300 ng/mL | 100% |
| Nortriptyline (Cut-off=1000 ng/mL) | Result | % Cross-Reactivity |
| --- | --- | --- |
| Nortriptyline | Positive at 1000 ng/mL | 100% |
| Amitriptyline | Positive at 1500 ng/mL | 67% |
| Clomipramine | Positive at 50000 ng/mL | 2% |
| Desipramine | Positive at 5000 ng/mL | 20% |
| Doxepine | Positive at 10000 ng/mL | 10% |
| Imipramine | Positive at 10000 ng/mL | 10% |
| Maprotiline | Positive at 100000 ng/mL | 1% |
| Nordoxepin | Positive at 10000 ng/mL | 10% |
| Promazine | Positive at 50000 ng/mL | 2% |
| Promethazine | Positive at 2500 ng/mL | 40% |
| Trimipramine | Positive at 50000 ng/mL | 2% |
| Cyclobenzaprine Hydrochloride | Positive at 5000 ng/mL | 20% |
| Norclomipramine | Positive at 50000 ng/mL | 2% |
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Interference studies were performed using 100 µg/mL of commonly administered or OTC compounds (endogenous compounds, drugs, drug metabolites) that are commonly found in urine. These compounds were tested in urine containing ±25% cutoff concentration for each analyte using three lots of each device for all formats. The following compounds were found not to interfere when tested at 100 µg/mL concentration.
## Propoxyphene
| Acetophenetidin | Ethyl-p-aminobenzoate | Perphenazine |
| --- | --- | --- |
| N-Acetylprocainamide | Fenoprofen | Phencyclidine |
| Acetylsalicylic Acid (Aspirin) | Furosemide | Phenelzine |
| Aminopyrine | Gentisic acid | Phenobarbital |
| Amitriptyline | Hemoglobin | Phentermine |
| Amoxicillin | Hydralazine | Phenylephrine-L |
| Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Phenylethylamine |
| D-Amphetamine | Hydrochlorothiazide | Phenylpropanolamine |
| EDDP (Cut-off=300 ng/mL) | Result | % Cross-Reactivity |
| --- | --- | --- |
| EDDP (2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine) | Positive at 300ng/mL | 100% |
| EMDP (2-Ethyl-5-methyl-3,3- diphenylpyrroline) | Positive at 500 ng/mL | 60% |
| Disopyramide | Positive at 50000 ng/mL | 1% |
| Methadone | Negative at 100000 ng/mL | <0.3% |
| LAAM (Levo-alpha-acetylmethadol) HCl | Negative at 100000 ng/mL | <0.3% |
| Alpha Methadol | Negative at 100000 ng/mL | <0.3% |
| Doxylamine | Negative at 100000 ng/mL | <0.3% |
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| L-Amphetamine | Hydrocodone | Prednisolone Acetate |
| --- | --- | --- |
| Amphetamine Sulfate | Hydrocortisone | Prednisone |
| Ampicinine(Ampicillin) | a-Hydroxyhippuric acid | Procaine(Novocaine) |
| Apomorphine | p-Hydroxymethamphetamine | Promazine |
| L-Ascorbic Acid | Ibuprofen | Promethazine |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
| Benzoic Acid | Labetalol | Ranitidine(Zantac) |
| Bilirubin | Levorphanol | Salicylic Acid |
| Caffeine | Loperamide | Secobarbital |
| Chloramphenicol | Maprotiline | Serotonin |
| Chlordiazepoxide HCL | Meprobamate | Sulfamethazine |
| Chloroquine | Methadone | Sulindac |
| Chlorothiazide | Methoxyphenamine | Temazepam |
| Chlorpheniramine | (+/-)Methylenedioxyamphetamine (MDA) | 11-Nor-Δ9-Tetrahydrocannabinol |
| Chlorpromazine | Methylphenidate | Tetracycline |
| Cholesterol | Nalbuphine | Tetrahydrozoline |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | Thioridazine Hydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine Hydrochloride |
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | Noscapine | Tryptamine |
| Diflunisal | Oxazepam | DL-Tryptophan |
| Digoxin | Oxymetazoline | Tyramine |
| Doxylamine | Papaverine | D/L-Tyrosine |
| Ecgonine methylester | Penicillin | Uric Acid |
| R(-)-Epinephrine | Pentobarbital | Verapamil |
| Erythromycin | Perphenazine | Zomepirac |
| Estrone-3-sulfate | Phencyclidine | |
{11}
14
# Nortriptyline
| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
| --- | --- | --- |
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid (Aspirin) | Furosemide | Phenobarbital |
| Aminopyrine | Gentisic acid | Phentermine |
| Amoxicillin | Hemoglobin | Phenylephrine-L |
| Amobarbital | Hydralazine | Phenylethylamine |
| D-Amphetamine | (+/-)-4-Hydroxyamphetamine HCL | Phenylpropanolamine |
| L-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| Amphetamine Sulfate | Hydrocodone | Prednisone |
| Ampicinine(Ampicillin) | Hydrocortisone | Procaine(Novocaine) |
| Apomorphine | α-Hydroxyhippuric acid | Propoxyphene,d- |
| L-Ascorbic Acid | p-Hydroxymethamphetamine | Propranolol |
| Aspartame | Ibuprofen | Pseudoephedrine HCL |
| Atropine | Isoxsuprine | Quinidine |
| Benzilic acid | Isoproterenol-(+/-) | Quinine |
| Benzphetamine | Ketamine | Ranitidine(Zantac) |
| Bezoic Acid | Labetalol | Salicylic Acid |
| Bilirubin | Levorphanol | Secobarbital |
| Caffeine | Loperamide | Serotonin |
| Chloramphenicol | Meprobamate | Sulfamethazine |
| Chlordiazepoxide HCL | Methadone | Sulindac |
| Chloroquine | Methoxyphenamine | Temazepam |
| Chlorothiazide | (+/-)Methylenedioxyamphetamine (MDA) | 11-Nor-Δ9-Tetrahydrocannabinol |
| Chlorpheniramine | Methylphenidate | Tetracycline |
| Chlorpromazine | Nalbuphine | Tetrahydrozoline |
| Cholesterol | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine Hydrochloride |
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Tryptamine |
{12}
EDDP
| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
| --- | --- | --- |
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid (Aspirin) | Furosemide | Phenobarbital |
| Aminopyrine | Gentisic acid | Phentermine |
| Amitriptyline | Hemoglobin | Phenylephrine-L |
| Amoxicillin | Hydralazine | Phenylethylamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Phenylpropanolamine |
| D-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| L-Amphetamine | Hydrocodone | Prednisone |
| Amphetamine Sulfate | Hydrocortisone | Procaine(Novocaine) |
| Ampicinine(Ampicillin) | a-Hydroxyhippuric acid | Promazine |
| Apomorphine | p-Hydroxymethamphetamine | Promethazine |
| L-Ascorbic Acid | Ibuprofen | Propoxyphene,d- |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
| Bezoic Acid | Labetalol | Ranitidine(Zantac) |
| Bilirubin | Levorphanol | Salicylic Acid |
| Caffeine | Loperamide | Secobarbital |
| Chloramphenicol | Maprotiline | Serotonin |
| Chlordiazepoxide HCL | Meprobamate | Sulfamethazine |
| Chloroquine | Methadone | Sulindac |
| Chlorothiazide | Methoxyphenamine | Temazepam |
| Chlorpheniramine | (+/-)-Methylenedioxyamphetamine (MDA) | 11-Nor-Δ9-Tetrahydrocannabinol |
{13}
| Chlorpromazine | Methylphenidate | Tetracycline |
| --- | --- | --- |
| Cholesterol | Nalbuphine | Tetrahydrozoline |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | Thioridazine Hydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine Hydrochloride |
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | Norpropoxyphene | Tryptamine |
| Diflunisal | Noscapine | DL-Tryptophan |
| Digoxin | Oxazepam | Tyramine |
| Doxylamine | Oxymetazoline | D/L-Tyrosine |
| Ecgonine methylester | Papaverine | Uric Acid |
| R(-)-Epinephrine | Penicillin | Verapamil |
| Erythromycin | Pentobarbital | Zomepirac |
| Estrone-3-sulfate | Perphenazine | |
Specific Gravity and pH studies:
Twelve urine samples with specific gravity ranges (1.000-1.035) were collected and spiked with each drug at 25% below and 25% above cutoff levels. Each sample was tested using three lots of each format of the test devices. The results showed that a specific gravity range of 1.000 to 1.035 does not affect the accuracy of the tests.
A negative urine pool was adjusted to a pH range of 4.00 to 9.00 in 1 pH unit increments and was spiked with each drug at 25% below and 25% above cutoff levels. Samples were tested using three lots of each format of the devices, and results showed that urine pH range of 4.00 to 9.00 does not affect the accuracy of the tests.
f. Assay cut-off:
The characterization of how the device performs analytically around the claimed cutoff concentration of 300 ng/mL Propoxyphene, 1000 ng/mL Nortriptyline, and 300 ng/mL EDDP is described in the precision section, M.1.a. above.
{14}
2. Comparison studies:
a. Method comparison with predicate device:
The method comparison for the Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP Test was performed internally against the reference method, GC/MS. Operators ran 80 unaltered urine samples on each format of the devices, where each device format was tested by an independent set of three operators. The samples were masked and randomized prior to testing and device results were compared to GC/MS. The results are presented in the table below:
Propoxyphene
| Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of Propoxyphene Strip
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |
17
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18
| Cassette format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of Propoxyphene Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |
| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
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19
# Discordant Results of Propoxyphene Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer B | PPX66 | 304 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
# Discordant Results of Propoxyphene Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | PPX67 | 301 | Negative |
| Viewer A | PPX66 | 304 | Negative |
| Viewer B | PPX67 | 301 | Negative |
| Viewer B | PPX66 | 304 | Negative |
| Viewer C | PPX67 | 301 | Negative |
| Viewer C | PPX66 | 304 | Negative |
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20
# Nortriptyline
| Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
# Discordant Results of Nortriptyline Strip
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | TCA27 | 1011 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA27 | 1011 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA27 | 1011 | Negative |
| Cassette format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
{18}
Discordant Results of Nortriptyline Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | TCA51 | 1025 | Negative |
| Viewer A | TCA34 | 1232 | Negative |
| Viewer A | TCA52 | 1123 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA34 | 1232 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA34 | 1232 | Negative |
| Viewer C | TCA52 | 1123 | Negative |
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of Nortriptyline Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | TCA51 | 1025 | Negative |
| Viewer A | TCA27 | 1011 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA27 | 1011 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA27 | 1011 | Negative |
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22
| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
## Discordant Results of Nortriptyline Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | TCA51 | 1025 | Negative |
| Viewer A | TCA27 | 1011 | Negative |
| Viewer A | TCA38 | 1097 | Negative |
| Viewer B | TCA51 | 1025 | Negative |
| Viewer B | TCA27 | 1011 | Negative |
| Viewer B | TCA38 | 1097 | Negative |
| Viewer C | TCA51 | 1025 | Negative |
| Viewer C | TCA27 | 1011 | Negative |
| Viewer C | TCA38 | 1097 | Negative |
## EDDP
| Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
{20}
23
# Discordant Results of EDDP Strip
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | EDDP28 | 308 | Negative |
| Viewer A | EDDP02 | 302 | Negative |
| Viewer A | EDDP72 | 303 | Negative |
| Viewer B | EDDP02 | 302 | Negative |
| Viewer B | EDDP72 | 303 | Negative |
| Viewer C | EDDP28 | 308 | Negative |
| Viewer C | EDDP02 | 302 | Negative |
| Viewer C | EDDP72 | 303 | Negative |
| Cassette format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
# Discordant Results of EDDP Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | EDDP28 | 308 | Negative |
| Viewer A | EDDP02 | 302 | Negative |
| Viewer A | EDDP72 | 303 | Negative |
| Viewer B | EDDP02 | 302 | Negative |
| Viewer B | EDDP72 | 303 | Negative |
| Viewer C | EDDP28 | 308 | Negative |
| Viewer C | EDDP02 | 302 | Negative |
| Viewer C | EDDP72 | 303 | Negative |
{21}
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of EDDP Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | EDDP02 | 302 | Negative |
| Viewer A | EDDP72 | 303 | Negative |
| Viewer B | EDDP28 | 308 | Negative |
| Viewer B | EDDP02 | 302 | Negative |
| Viewer B | EDDP72 | 303 | Negative |
| Viewer C | EDDP02 | 302 | Negative |
| Viewer C | EDDP72 | 303 | Negative |
| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
{22}
25
# Discordant Results of EDDP Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
| --- | --- | --- | --- |
| Viewer A | EDDP02 | 302 | Negative |
| Viewer A | EDDP72 | 303 | Negative |
| Viewer B | EDDP02 | 302 | Negative |
| Viewer B | EDDP72 | 303 | Negative |
| Viewer C | EDDP02 | 302 | Negative |
| Viewer C | EDDP72 | 303 | Negative |
b. Matrix comparison:
Not applicable. The assays are intended to be used with urine samples only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
A lay user study was performed at three intended user sites with 560 lay persons testing each of the Propoxyphene, the Nortriptyline and the EDDP devices. Total of 1680 individuals performed the study. A total of 204 females and 356 males tested the Propoxyphene samples, 213 females and 347 males tested the Nortriptyline samples and 209 females and 351 males tested the EDDP samples. They had diverse educational and professional backgrounds and ranged in age from 21 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 GC/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. The results are summarized below.
{23}
Comparison between GC/MS and Lay Person Results (Propoxyphene Strip)
| % of Cutoff | Number of samples | Propoxyphene Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Propoxyphene Cassette)
| % of Cutoff | Number of samples | Propoxyphene Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Propoxyphene DipCard)
| % of Cutoff | Number of samples | Propoxyphene Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
26
{24}
Comparison between GC/MS and Lay Person Results (Propoxyphene Cup)
| % of Cutoff | Number of samples | Propoxyphene Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Nortriptyline Strip)
| % of Cutoff | Number of samples | Nortriptyline Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Nortriptyline Cassette)
| % of Cutoff | Number of samples | Nortriptyline Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 1250 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
27
{25}
Comparison between GC/MS and Lay Person Results (Nortriptyline DipCard)
| % of Cutoff | Number of samples | Nortriptyline Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Nortriptyline Cup)
| % of Cutoff | Number of samples | Nortriptyline Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (EDDP Strip)
| % of Cutoff | Number of samples | EDDP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
28
{26}
Comparison between GC/MS and Lay Person Results (EDDP Cassette)
| % of Cutoff | Number of samples | EDDP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (EDDP Dipcard)
| % of Cutoff | Number of samples | EDDP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (EDDP Cup)
| % of Cutoff | Number of samples | EDDP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
29
{27}
The labeling is rated at 7th grade reading level per Flesch-Kincaid Methodology. All participants (100%) indicated on the questionnaire that the labeling instructions were clear or very clear and that they did not find the tests difficult to operate.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
30
