Rapid Tox Cup II
Device Facts
| Record ID | K170222 |
|---|---|
| Device Name | Rapid Tox Cup II |
| Applicant | American Bio Medica Corp. |
| Product Code | LAF · Clinical Toxicology |
| Decision Date | Aug 15, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Indications for Use
The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen: Amphetamines (D-amphetamine) (1000 & 500 ng/mL), Barbiturates (Butalbital) (300 ng/mL), Benzodiazepines (Oxazepam) (300 ng/mL), Buprenorphine (12.5 ng/mL), Cocaine (Benzoylecgonine) (300 & 150 ng/mL), MDMA (Methylenedioxymethamphetamine) (500 ng/mL), Methadone (300 ng/mL), Methamphetamine (D-methamphetamine) (1000 & 500 ng/mL), Opiates (Morphine) (2000 & 300 ng/mL), Oxycodone (100 ng/mL), Phencyclidine (25 ng/mL), Marijuana (11-nor-Δ9-THC-9-carboxylic-acid) (50 ng/mL), Tricyclic Antidepressants (Nortriptyline) (1000 ng/mL). The test is intended for over-the-counter use. This assay may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assay is not intended to distinguish between prescription use or abuse of these drugs. Rapid TOX Cup II provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.
Device Story
Rapid TOX Cup II is a urine collection cup with integrated temperature strip and test inserts; designed for qualitative detection of 13 drug classes. Operates via lateral flow immunoassay; urine sample migrates by capillary action across membrane strips containing immobilized drug conjugates and colloidal gold-labeled antibodies. Competitive binding principle: drug in urine competes with immobilized conjugate for antibody binding sites. Two visible lines (control and test) indicate negative result; one line (control only) indicates preliminary positive result. Used by untrained consumers or professionals in point-of-care settings. Provides preliminary screening results; requires follow-up with specific confirmatory methods like GC/MS or LC-MS/MS. Enables rapid initial assessment of drug presence to guide clinical or professional decision-making.
Clinical Evidence
Clinical evidence consists of a consumer user study evaluating performance by untrained individuals. Participants tested prepared samples at various concentrations (negative, low negative, near negative, near positive, high positive). Results demonstrated high concordance with expected outcomes across all 13 drug analytes, confirming that lay users can accurately interpret the qualitative results.
Technological Characteristics
Qualitative lateral flow immunoassay. Materials: Polyethylene cup. Dimensions: 64 mm x 3.5 mm test strips. Sensing: Competitive binding with colloidal gold-labeled antibody. Energy: None (passive capillary action). Connectivity: None. Sterilization: Not stated. Software: None.
Indications for Use
Indicated for qualitative detection of drugs of abuse in human urine specimens for over-the-counter use. Target population includes individuals seeking preliminary screening for amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, MDMA, methadone, methamphetamines, opiates, oxycodone, phencyclidine, THC, and tricyclic antidepressants. Not intended to distinguish between prescription use and abuse.
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine 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
- Rapid TOX Cup (k073078)
Related Devices
- K073078 — RAPID TOX CUP · American Bio Medica Corp. · May 30, 2008
- K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test · Chemtron Biotech, Inc. · Dec 20, 2023
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k170222
B. Purpose for Submission:
Modification to the test strip size of previously cleared Prescription-only device and addition of Over The Counter (OTC) claim.
C. Measurands:
Amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, MDMA, methadone, methamphetamines, opiates, oxycodone, phencyclidine, THC/Cannabinoids, and tricyclic antidepressants.
D. Type of Test:
Qualitative lateral flow immunoassay
E. Applicant:
American Bio Medica Corporation, Inc.
F. Proprietary and Established Names:
Rapid TOX Cup II
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21CFR 862.3100, Amphetamine Test System | Toxicology (91) |
| DIS | Class II | 21 CFR 862.3150, Barbiturates Test System | Toxicology (91) |
| JXM | Class II | 21 CFR 862.3170, Benzodiazepines Test System | Toxicology (91) |
| DJG | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
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| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DIO | Class II | 21 CFR 862.3250, Cocaine and metabolites Test System | Toxicology (91) |
| LAF | Class II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
| DJR | Class II | 21 CFR 862.3620, Methadone Test System | Toxicology (91) |
| LCM | Unclassified, 510(k) required | Enzyme Immunoassay, Phencyclidine | Toxicology (91) |
| LDJ | Class II | 21 CFR 862.3870 Cannabinoid test system | Toxicology (91) |
| LFG | Class II | 21 CFR 862.3910, Tricyclic antidepressant drugs test system | Toxicology (91) |
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H. Intended Use:
1. Intended use(s):
Refer to Indications for Use.
2. Indication(s) for use:
The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen:
| Analyte | Calibrator | Cutoff (ng/mL) |
| --- | --- | --- |
| Amphetamine | D-amphetamine | 1000 |
| Amphetamine | D-amphetamine | 500 |
| Barbiturates (Butalbital) | Butalbital | 300 |
| Benzodiazepines (Oxazepam) | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 12.5 |
| Cocaine | Benzoylecgonine | 300 |
| Cocaine | Benzoylecgonine | 150 |
| MDMA | MDMA (Methylenedioxymethamphetamine) | 500 |
| Methadone | Methadone | 300 |
| Methamphetamine | D-methamphetamine | 1000 |
| Methamphetamine | D-methamphetamine | 500 |
| Opiates | Morphine | 2000 |
| Opiates | Morphine | 300 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencyclidine | 25 |
| Marijuana | 11-nor-Δ9-THC-9-carboxylic-acid | 50 |
| Tricyclic Antidepressants | Nortriptyline | 1000 |
The test is intended for over-the-counter use.
This assay may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assay is not intended to distinguish between prescription use or abuse of these drugs.
Rapid TOX Cup II provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.
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3. Special conditions for use statement(s):
For over-the-counter, in vitro diagnostic use only.
4. Special instrument requirements:
Not applicable, as the devices are visually-read single-use devices.
I. Device Description:
The devices consist of:
- A test cup (and lid) with 3 to 5 drug test strips with each strip testing for either 1 or 4 drugs simultaneously. Configuration 1 provides 5 test strips to test for a total of 14 drugs. Configuration 2 provides 3 test strips to test for a total of 12 drugs. The test cup and lid come in a sealed foil pouch.
- Package insert (instructions for use)
- Pre-addressed mailing box, plastic transport bag and identification label to send the sample for confirmation lab testing.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Rapid TOX Cup
2. Predicate 510(k) number(s):
k073078
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device: Rapid TOX Cup II | Predicate – k073078 Rapid TOX Cup |
| Specimen | Urine | Same |
| Test Format | Cup | Same |
| Intended Use | Qualitative detection of one or more drugs of abuse | Same |
| Methodology | Qualitative one-step lateral flow immunoassay | Same |
| Differences | | |
| --- | --- | --- |
| | Candidate Device: Rapid TOX Cup II | Predicate – k073078 Rapid TOX Cup |
| Use Setting | Over-the-counter use | For professional use only |
| Analytes | Amphetamine 1000 ng/mL | Amphetamine 1000 ng/mL |
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| Differences | | |
| --- | --- | --- |
| | Candidate Device: Rapid TOX Cup II | Predicate – k073078 Rapid TOX Cup |
| | Amphetamine 500 ng/mL
Methamphetamine 1000 ng/mL
Methamphetamine 500 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL
Buprenorphine 12.5 ng/mL
Benzodiazepines (Oxazepam) 300 ng/mL
Barbiturates (Butalbital) 300 ng/mL
Oxycodone 100 ng/mL
Methadone 300 ng/mL
Phencyclidine 25 ng/mL
Opiates 300 ng/mL
Opiates 2000 ng/mL
Cocaine (Benzoylecgonine) 300 ng/mL
Cocaine (Benzoylecgonine) 150 ng/mL
Tricyclic Antidepressants (Nortriptyline) 1000 ng/mL
THC/Cannabinoids (11 norΔ9-THC-9-carboxylic acid) 50 ng/mL | Amphetamine 500 ng/mL
Methamphetamine 1000 ng/mL
Methamphetamine 500 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL
Buprenorphine 12.5 ng/mL
Benzodiazepines (Oxazepam) 300 ng/mL
Barbiturates (Butalbital) 300 ng/mL
Oxycodone 100 ng/mL
Methadone 300 ng/mL
Phencyclidine 25 ng/mL
Propoxyphene 300 ng/mL
Opiates 300 ng/mL
Opiates 2000 ng/mL
Cocaine (Benzoylecgonine) 300 ng/mL
Cocaine (Benzoylecgonine) 150 ng/mL
Tricyclic Antidepressants (Nortriptyline) 1000 ng/mL
THC/Cannabinoids (11 norΔ9-THC-9-carboxylic acid) 50 ng/mL |
| Test Strip size | 64 mm x 3.5 mm | 84 mm x 5 mm |
| Jar and insert size | Insert is a smaller size to accommodate smaller test strips; Jar is same size (8oz) with a wider mouth to facilitate sample collection | Insert accommodates strip size Jar is 8oz. |
| Cup composition | Polyethylene | Polypropylene |
K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
Each Rapid TOX Cup II test device contains test strips for several drugs of abuse. The test
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strip consists of a membrane strip with an immobilized drug conjugate. A colloidal gold-labeled antibody complex is dried at one end of the membrane. The specifically labeled drug (drug conjugate) competes for antibody binding sites with drugs or metabolites that may be present in the urine specimen.
An internal quality control line, comprised of a different antibody/antigen reaction is contained in on each membrane strip. The control line is not influenced by the presence or absence of drug analytes in the urine specimen, and therefore, it should be visible in all samples tested.
In the absence of specified drug(s) in the urine specimen, the colloidal gold-labeled antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of two (2) visible lines (control and test lines) occurs when the test is negative or below the cutoff for the drug.
When a drug analyte is present in the urine specimen, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the antibody binding sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug analyte is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. The formation of a control line, and the absence of a test line is indicative of a preliminary positive result.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Each analyte for the precision study was tested at the following concentrations: Negative, and -75%, -50%, -25%, +25%, +50% and +75% of the specific cutoff for each drug assay. The panels were blinded and randomized prior to testing. Testing was performed using 3 lots of ABMC test strips and was performed once a day by 3 operators over 12 consecutive days, and the results of this testing are summarized as follows for each device.
Amphetamines 1000
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 250 | -75% | 36 neg / 0 pos |
| 500 | -50% | 36 neg / 0 pos |
| 750 | -25% | 33 neg / 3 pos |
| 1250 | +25% | 0 neg / 36 pos |
| 1500 | +50% | 0 neg / 36 pos |
| 1750 | +75% | 0 neg / 36 pos |
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Methamphetamines 1000
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 250 | -75% | 36 neg / 0 pos |
| 500 | -50% | 36 neg / 0 pos |
| 750 | -25% | 31 neg / 5 pos |
| 1250 | +25% | 0 neg / 36 pos |
| 1500 | +50% | 0 neg / 36 pos |
| 1750 | +75% | 0 neg / 36 pos |
Amphetamines 500
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 125 | -75% | 36 neg / 0 pos |
| 250 | -50% | 36 neg / 0 pos |
| 375 | -25% | 27 neg / 9 pos |
| 625 | +25% | 0 neg / 36 pos |
| 750 | +50% | 0 neg / 36 pos |
| 875 | +75% | 0 neg / 36 pos |
Methamphetamines 500
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 125 | -75% | 36 neg / 0 pos |
| 250 | -50% | 36 neg / 0 pos |
| 375 | -25% | 31 neg / 5 pos |
| 625 | +25% | 0 neg / 36 pos |
| 750 | +50% | 0 neg / 36 pos |
| 875 | +75% | 0 neg / 36 pos |
MDMA 500
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 125 | -75% | 36 neg / 0 pos |
| 250 | -50% | 36 neg / 0 pos |
| 375 | -25% | 28 neg / 8 pos |
| 625 | +25% | 0 neg / 36 pos |
| 750 | +50% | 0 neg / 36 pos |
| 875 | +75% | 0 neg / 36 pos |
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Cocaine 300
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 75 | -75% | 36 neg / 0 pos |
| 150 | -50% | 36 neg / 0 pos |
| 225 | -25% | 33 neg / 3 pos |
| 375 | +25% | 0 neg / 36 pos |
| 450 | +50% | 0 neg / 36 pos |
| 525 | +75% | 0 neg / 36 pos |
Cocaine 150
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 37.5 | -75% | 36 neg / 0 pos |
| 75 | -50% | 36 neg / 0 pos |
| 112.5 | -25% | 32 neg / 4 pos |
| 187.5 | +25% | 0 neg / 36 pos |
| 225 | +50% | 0 neg / 36 pos |
| 262.5 | +75% | 0 neg / 36 pos |
Opiates 2000
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 500 | -75% | 36 neg / 0 pos |
| 1000 | -50% | 36 neg / 0 pos |
| 1500 | -25% | 30 neg / 6 pos |
| 2500 | +25% | 0 neg / 36 pos |
| 3000 | +50% | 0 neg / 36 pos |
| 3500 | +75% | 0 neg / 36 pos |
Opiates 300
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 75 | -75% | 36 neg / 0 pos |
| 150 | -50% | 36 neg / 0 pos |
| 225 | -25% | 30 neg / 6 pos |
| 375 | +25% | 0 neg / 36 pos |
| 450 | +50% | 0 neg / 36 pos |
| 525 | +75% | 0 neg / 36 pos |
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Benzodiazepines 300
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 75 | -75% | 36 neg / 0 pos |
| 150 | -50% | 36 neg / 0 pos |
| 225 | -25% | 30 neg / 6 pos |
| 375 | +25% | 0 neg / 36 pos |
| 450 | +50% | 0 neg / 36 pos |
| 525 | +75% | 0 neg / 36 pos |
Barbiturates 300
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 75 | -75% | 36 neg / 0 pos |
| 150 | -50% | 36 neg / 0 pos |
| 225 | -25% | 30 neg / 6 pos |
| 375 | +25% | 0 neg / 36 pos |
| 450 | +50% | 0 neg / 36 pos |
| 525 | +75% | 0 neg / 36 pos |
Methadone 300
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 75 | -75% | 36 neg / 0 pos |
| 150 | -50% | 36 neg / 0 pos |
| 225 | -25% | 34 neg / 2 pos |
| 375 | +25% | 0 neg / 36 pos |
| 450 | +50% | 0 neg / 36 pos |
| 525 | +75% | 0 neg / 36 pos |
PCP 25
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 6.25 | -75% | 36 neg / 0 pos |
| 12.5 | -50% | 36 neg / 0 pos |
| 18.75 | -25% | 33 neg / 3 pos |
| 31.25 | +25% | 0 neg / 36 pos |
| 37.5 | +50% | 0 neg / 36 pos |
| 43.75 | +75% | 0 neg / 36 pos |
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THC 50
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 12.5 | -75% | 36 neg / 0 pos |
| 25 | -50% | 36 neg / 0 pos |
| 37.5 | -25% | 35 neg / 1 pos |
| 62.5 | +25% | 0 neg / 36 pos |
| 75 | +50% | 0 neg / 36 pos |
| 87.5 | +75% | 0 neg / 36 pos |
TCA 1000
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 250 | -75% | 36 neg / 0 pos |
| 500 | -50% | 36 neg / 0 pos |
| 750 | -25% | 30 neg / 6 pos |
| 1250 | +25% | 0 neg / 36 pos |
| 1500 | +50% | 0 neg / 36 pos |
| 1750 | +75% | 0 neg / 36 pos |
Buprenorphine 12.5
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 3.125 | -75% | 36 neg / 0 pos |
| 6.25 | -50% | 36 neg / 0 pos |
| 9.375 | -25% | 33 neg / 3 pos |
| 15.625 | +25% | 0 neg / 36 pos |
| 18.75 | +50% | 0 neg / 36 pos |
| 21.875 | +75% | 0 neg / 36 pos |
Oxycodone 100
| Concentration (ng/mL) | % of cutoff | Results (Neg / Pos) |
| --- | --- | --- |
| 0 | 0 | 36 neg / 0 pos |
| 25 | -75% | 36 neg / 0 pos |
| 50 | -50% | 36 neg / 0 pos |
| 75 | -25% | 35 neg / 1 pos |
| 125 | +25% | 0 neg / 36 pos |
| 150 | +50% | 0 neg / 36 pos |
| 175 | +75% | 0 neg / 36 pos |
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b. Linearity/assay reportable range:
Not applicable. These devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The device has internal process controls. A control line appears in the control region confirming that sufficient sample volume has been applied to the test strip and that the sample has migrated correctly on the test strip. Users are informed that the test is invalid if the colored line does not appear in the control region. There are no external controls supplied with the device.
Device stability has been evaluated through accelerated and real-time studies. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that the devices are stable for two years (24 months) when stored at $2 - 30^{\circ}\mathrm{C}$ . Real-time studies are ongoing.
d. Detection limit:
See precision data in Section M1a above for assay performance around the claimed cutoff concentrations.
e. Analytical specificity:
The cross-reactivity of structurally similar compounds was evaluated in k073078.
Interferences. Potential interference of structurally dissimilar and endogenous compounds was evaluated in k073078. The following additional compounds were also tested for interference, where exogenous and endogenous compounds into samples at - 50% and -50% of the cutoff. No positive or negative interference was observed from any of the following compounds when present at 100,000 ng/mL:
| Acetaminophen | AcetylsalicylicAcid/Aspirin | Albumin |
| --- | --- | --- |
| Amikacin | Ampicillin | Arterenal |
| Atropine | Benzoic Acid | Bilirubin |
| Caffeine | Creatine | Ethanol |
| Glucose | Hemoglobin | Lidocaine |
| Methanol | Oxalic Acid | Penicillin-G |
| Phenylpropanalamine | Ranitidine | Salicylic Acid |
| Thioridazine | Trifluoperazine | Uric Acid |
| Vitamin C | | |
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# Specific gravity and pH
The effect of specific gravity for each analyte was evaluated by testing positive and negative samples at specific gravities ranging from 1.00 to 1.035. No interference was observed for all specific gravities tested.
The effect of pH for each analyte was evaluated by testing positive and negative samples over a range of pH levels. No interference was observed for all pH levels tested.
## f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M.1.a., above.
## 2. Comparison studies:
### a. Method comparison with predicate device:
The sponsor performed a method comparison study using unaltered clinical specimens and compared results from the Rapid TOX Cup II (RTC II) to a reference method. Results are summarized below:
AMP 500
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1* | 6 | 50 |
| Negative | 38 | 4 | 0 | 0 |
*For the single false positive for Amphetamines, the concentration was determined by GC/MS to be 487 ng/mL.
AMP 1000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 43 |
| Negative | 45 | 9 | 0 | 0 |
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BAR 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 37 |
| Negative | 35 | 5 | 0 | 0 |
BZO 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 37 |
| Negative | 54 | 8 | 0 | 0 |
BUP 12.5
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 11 | 46 |
| Negative | 172 | 10 | 0 | 0 |
COC 150
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 5 | 51 |
| Negative | 33 | 7 | 0 | 0 |
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COC 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 37 |
| Negative | 35 | 9 | 0 | 0 |
MDMA 500
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 7 | 33 |
| Negative | 50 | 4 | 0 | 0 |
MTD 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 8 | 41 |
| Negative | 31 | 10 | 0 | 0 |
METH 500
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 5 | 42 |
| Negative | 41 | 4 | 0 | 0 |
{14}
METH 1000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 5 | 39 |
| Negative | 47 | 6 | 0 | 0 |
OPI 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 56 |
| Negative | 152 | 5 | 0 | 0 |
OPI 2000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 40 |
| Negative | 164 | 5 | 0 | 0 |
OXY 100
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 5 | 62 |
| Negative | 35 | 10 | 0 | 0 |
{15}
PCP 25
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1* | 5 | 35 |
| Negative | 30 | 10 | 0 | 0 |
*For the single false positive for PCP, the concentration was determined by GC/MS to be 24.8 ng/mL
TCA 1000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 11 | 29 |
| Negative | 40 | 5 | 0 | 0 |
THC 50
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 35 |
| Negative | 24 | 25 | 0 | 0 |
b. Matrix comparison:
Not applicable. These devices are for use with urine samples only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
{16}
c. Other clinical supportive data (when a. and b. are not applicable):
A consumer study was performed for all analytes to evaluate the ability of untrained users to interpret the devices properly when given only the labeling (package insert) provided with the devices. A total of 430 demographically diverse untrained consumers at three sites took part in the study, with enrollment and testing over the course of five (5) days. Each day, individual participants tested two (2) contrived samples using one of two product configurations. On the last day, 20 participants only tested one (1) contrived sample.
Samples were created by spiking the analyte into drug-free urine pool. Each sample was aliquoted into an individual blind-labeled container. The concentrations analyzed for each analyte and cutoff were negative, 25%, 50%, 75%, 125%, 150%, and 175% of the cutoff, and were confirmed by a reference method. The results are summarized below:
AMP 500
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 5 | 40 | 20 |
| Negative | 40 | 35 | 0 | 0 |
AMP 1000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 40 | 20 |
| Negative | 100 | 39 | 0 | 0 |
BAR 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 40 | 20 |
| Negative | 100 | 37 | 0 | 0 |
{17}
BZO 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 40 | 20 |
| Negative | 80 | 37 | 0 | 0 |
BUP 12.5
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 40 | 20 |
| Negative | 160 | 38 | 0 | 0 |
COC 150
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 40 | 20 |
| Negative | 40 | 38 | 0 | 0 |
COC 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 40 | 20 |
| Negative | 60 | 39 | 0 | 0 |
{18}
MDMA 500
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 4 | 40 | 20 |
| Negative | 40 | 36 | 0 | 0 |
MTD 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 40 | 20 |
| Negative | 60 | 39 | 0 | 0 |
METH 500
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 40 | 20 |
| Negative | 40 | 37 | 0 | 0 |
METH 1000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 40 | 20 |
| Negative | 80 | 38 | 0 | 0 |
{19}
OPI 300
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 40 | 20 |
| Negative | 40 | 37 | 0 | 0 |
OPI 2000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 40 | 20 |
| Negative | 80 | 37 | 0 | 0 |
OXY 100
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 40 | 20 |
| Negative | 100 | 39 | 0 | 0 |
PCP 25
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 40 | 20 |
| Negative | 100 | 38 | 0 | 0 |
20
{20}
21
# TCA 1000
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 40 | 20 |
| Negative | 100 | 38 | 0 | 0 |
# THC 50
| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 40 | 20 |
| Negative | 100 | 39 | 0 | 0 |
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.
