← Product Code [LAG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAG) · K073078

# RAPID TOX CUP (K073078)

_American Bio Medica Corp. · LAG · May 30, 2008 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAG/K073078

## Device Facts

- **Applicant:** American Bio Medica Corp.
- **Product Code:** [LAG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAG.md)
- **Decision Date:** May 30, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3610
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels: Amphetamine 1000 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 (Butabarbital) 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 (Amitriptyline) 1000 ng/mL THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) 50 ng/mL ‘Rapid Tox Cup’ is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS). The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. ‘Rapid Tox Cup’ 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 is a one-step lateral flow immunoassay for simultaneous qualitative detection of multiple drugs of abuse in human urine. Device consists of a polypropylene cup containing up to 8 multi-drug strips (up to 5 drugs per strip). Principle of operation: competitive binding immunoassay; drug/metabolite in urine competes with immobilized drug conjugate for limited antibody binding sites on colloidal gold-labeled antibody complex. Absence of color line in test area indicates positive result; presence of line indicates negative result. Control line confirms proper migration. Used in professional settings; operated by healthcare professionals. Provides preliminary screening results; requires confirmation by GC/MS. Benefits include rapid, simultaneous screening for multiple substances to guide clinical decision-making regarding confirmatory testing.

## Clinical Evidence

Bench testing only. Reproducibility evaluated using control urines at concentrations above/below cut-offs. Samples tested 4 times daily for 5 days. Results verified by GC/MS. Cross-reactivity tested against over 500 substances.

## Technological Characteristics

Lateral flow immunoassay; polypropylene cup housing; colloidal gold-antibody complex; capillary action; visual readout; no calibration required; 2-year shelf life; 5 mL minimum sample volume.

## Regulatory 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 Tec 4 ([K041712](/device/K041712.md))
- Rapid Tec 5 ([K023869](/device/K023869.md))
- Rapid Tox ([K053359](/device/K053359.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k073078

B. Purpose for Submission:
New device

C. Measurand:
Amphetamine, methamphetamine, 3,4-methylenediozymethamphetamine (MDMA), buprenorphine, benzodiazepines, barbiturates, oxycodone, methadone, phencyclidine, propoxyphene, opiates, cocaine, tricyclics antidepressants and THC.

D. Type of Test:
Qualitative Lateral Flow Immunoassay

E. Applicant:
American Bio Medica Corporation

F. Proprietary and Established Names:
Rapid Tox Cup

G. Regulatory Information:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LAG | II | 862.3610
Methamphetamine test system | 91 (Tox)  |
|  DJG | II | 862.3650, Enzyme Immunoassay, Opiates | 91 (Tox)  |
|  DIO | II | 862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites | 91 (Tox)  |
|  DKE | II | 862.3870 | 91 (Tox)  |

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|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|   |  | Cannabinoid test system |   |
|  LCM | Unclassified | 862.3100 Enzyme immunoassay, Phencyclidine | 91 (Tox)  |
|  DKZ | II | 862.3100 Amphetamine test system | 91 (Tox)  |
|  JXM | II | 862.3170 Enzyme immunoassay, Barbiturate | 91 (Tox)  |
|  DJR | II | 862.3620 Methadone test system | 91 (Tox)  |
|  LFI | II | 862.3910 Tricyclic antidepressant drugs test system | 91 (Tox)  |
|  JXN | II | 862.3700 Propoxyphene test system | 91 (Tox)  |

H. Intended Use:

1. Intended use(s):

See indications for use section below.

2. Indication(s) for use:

Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:

Amphetamine 1000 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 (Butabarbital) 300 ng/mL
Oxycodone 100 ng/mL
Methadone 300 ng/mL
Phencyclidine 25 ng/mL

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|  Propoxyphene | 300 | ng/mL  |
| --- | --- | --- |
|  Opiates | 300 | ng/mL  |
|  Opiates | 2000 | ng/mL  |
|  Cocaine (Benzoylecgonine) | 300 | ng/mL  |
|  Cocaine (Benzoylecgonine) | 150 | ng/mL  |
|  Tricyclic Antidepressants (Amitriptyline) | 1000 | ng/mL  |
|  THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) | 50 | ng/mL  |

‘Rapid Tox Cup’ is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS).

The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine.

‘Rapid Tox Cup’ 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.

3. Special conditions for use statement(s):

The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine.

‘Rapid Tox Cup’ 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.

4. Special instrument requirements:

Not applicable

I. Device Description:

The Rapid Tox Cup kit contains directions for use/package insert, 25 individually

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foil-pouched test devices. Each device consists of up to 8 multi drug strips that contain up to 5 drugs per strip. Strips are produced in many configurations The cups are preassembled and the drugs contained within are tamper proof and are not interchangeable.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

Amedica Bio Medica Rapid Tec 4, Rapid Tec 5, and Rapid Tox

2. Predicate K number(s):

k041712, k023869 and k053359, respectively

3. Comparison with predicate:

|  Similarities  |   |   |   |
| --- | --- | --- | --- |
|   | Rapid Tox Cup | Rapid Tox | Rapid Tec (4 and 5)  |
|  Device Test Strips | Identical Strips | Identical Strips | Identical Strips  |
|  Results Reading | Identical | Identical | Identical  |
|  Confirmation | Sample can be sent in the cup itself or in a separate container. | Sample sent out in separate container. | Sample sent out in separate container.  |
|  Quality Control | Control Line Observation for valid test | Control Line Observation for valid test | Control Line Observation for valid test  |
|  Storage | Identical | Identical | Identical  |
|  Shelf Life | 2 years | 2 years | 2 years  |
|  Rapid Reader compatible | No | Yes | Yes  |
|  Calibration Required | No | No | No  |
|  Cross Reactivity | Over 500 drugs tested, same results | Over 500 drugs tested, same results | Over 500 drugs tested, same results  |
|  Drug ID being tested | Drug abbreviation adjacent to test line | Drug abbreviation adjacent to test line | Drug abbreviation adjacent to test line  |
|  Differences  |   |   |   |
|  Device Housing | Cup Format | Cassette Format | Card Format  |
|  Sampling Method | Fill Cup | Dip or Pipette | Dip or Pipette  |
|  Time to Results | 3-5 minutes | 3-5 minutes | 5-7 minutes  |
|  Drug Testing Quantity | Can test to14 drugs | Can test up to 10 drugs | Can test up to 5 drugs  |
|  Rapid Reader | No | Yes | Yes  |

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|  compatible |  |  |   |
| --- | --- | --- | --- |
|  Stability Test Result | 8 hours | 8 hours | 1 hour  |
|  Minimum Sample Volume | 5 mL | 100 μl | 100 μl  |

## K. Standard/Guidance Document Referenced (if applicable):

None referenced

## L. Test Principle:

The immunoassays employed in each test strip of the ‘Rapid Tox Cup’ are based on the reaction between antigens and antibodies. Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all “test” areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled drug. When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color line in any of the test areas is indicative of a positive result. A control line, comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of a drug in the urine, and therefore, should be present in all reactions. Negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Reproducibility was evaluated using commercially available control materials. Each sample, at each concentrations of each drug, was tested 4 times a day, twice a day for 5 days. A total of 40 determinations, at each concentration, were made.

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Amphetamine-500 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  250 | 40 | 40 negative  |
|  400 | 40 | 38 negative  |
|  500 | 40 | 40 positive  |
|  625 | 40 | 40 positive  |

Amphetamine- 1000 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  500 | 40 | 40 negative  |
|  850 | 40 | 39 negative  |
|  1000 | 40 | 40 positive  |
|  1250 | 40 | 40 positive  |

Barbiturates- 300 ng/mL of butalbital

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  150 | 40 | 40 negative  |
|  225 | 40 | 40 negative  |
|  300 | 40 | 40 positive  |
|  375 | 40 | 40 positive  |

Benzodiazepines- 300 ng/mL of oxazepam

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  150 | 40 | 40 negative  |
|  225 | 40 | 40 negative  |
|  300 | 40 | 40 positive  |
|  375 | 40 | 40 positive  |

Methamphetamine-500 ng/mL

|  Conc. (ng/ml) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  250 | 40 | 40 negative  |
|  375 | 40 | 36 negative  |
|  500 | 40 | 40 positive  |
|  625 | 40 | 40 positive  |

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Methamphetamine- 1000 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  500 | 40 | 40 negative  |
|  750 | 40 | 40 negative  |
|  1000 | 40 | 40 positive  |
|  1250 | 40 | 40 positive  |

Buprenorphine- 12.5 ng/mL

|  Concentration (ng/mL) | Total Number of Determinations | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  3.2 | 40 | 40 negative  |
|  6.3 | 40 | 40 negative  |
|  9.4 | 40 | 40 negative  |
|  12.5 | 40 | 40 positive  |
|  15.6 | 40 | 40 positive  |

Cocaine- 150 ng/mL

|  Concentration (ng/mL) | Total Number of Determinations | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  75 | 40 | 40 negative  |
|  120 | 40 | 38 negative  |
|  150 | 40 | 40 positive  |
|  187 | 40 | 40 positive  |

Cocaine- 300 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  150 | 40 | 40 negative  |
|  225 | 40 | 40 negative  |
|  300 | 40 | 40 positive  |
|  375 | 40 | 40 positive  |

THC- 50 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  25 | 40 | 40 negative  |
|  38 | 40 | 40 negative  |
|  50 | 40 | 40 positive  |
|  75 | 40 | 40 positive  |

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Opiates-300 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  150 | 40 | 40 negative  |
|  225 | 40 | 39 negative  |
|  300 | 40 | 40 positive  |
|  375 | 40 | 40 positive  |

Opiates-2000 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  1000 | 40 | 40 negative  |
|  1500 | 40 | 40 negative  |
|  2000 | 40 | 40 positive  |
|  2500 | 40 | 40 positive  |

Oxycodone-100 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No Drug Present | 40 | 40 negative  |
|  25 | 40 | 40 negative  |
|  50 | 40 | 40 negative  |
|  75 | 40 | 40 negative  |
|  100 | 40 | 40 positive  |
|  125 | 40 | 40 positive  |

Methadone- 300 ng/mL

|  Conc. (ng/mL) | # | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  150 | 40 | 40 negative  |
|  225 | 40 | 40 negative  |
|  300 | 40 | 40 positive  |
|  375 | 40 | 40 positive  |

MDMA-500 ng/mL

|  Conc. (ng/mL) | Total Determinations | Results  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  250 | 40 | 40 negative  |
|  375 | 40 | 40 negative  |
|  500 | 40 | 40 positive  |
|  625 | 40 | 40 positive  |

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MDMA- 1000 ng/mL

|  Conc. (ng/mL) | Total Determinations | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  500 | 40 | 40 negative  |
|  750 | 40 | 40 negative  |
|  1000 | 40 | 40 positive  |
|  1250 | 40 | 40 positive  |

TCA- 1000 ng/mL of nortriptyline

|  Conc. (ng/mL) | Total Determinations | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  500 | 40 | 40 negative  |
|  750 | 40 | 39 negative  |
|  1000 | 40 | 40 positive  |
|  1250 | 40 | 40 positive  |

Propoxyphene- 300 ng/mL

|  Conc. (ng/mL) | Total determinations | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  150 | 40 | 40 negative  |
|  225 | 40 | 40 negative  |
|  300 | 40 | 40 positive  |
|  375 | 40 | 40 positive  |

PCP- 25 ng/mL

|  Conc. (ng/mL) | Total Determinations | Result  |
| --- | --- | --- |
|  No drug present | 40 | 40 negative  |
|  13 | 40 | 40 negative  |
|  19 | 40 | 39 negative  |
|  25 | 40 | 40 positive  |
|  38 | 40 | 40 positive  |

b. Linearity/assay reportable range:

Not applicable. The assay is for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

This device has internal process controls. A colored line appearing in the control region confirms that sufficient sample volume has been applied and that the sample has migrated correctly on the test strip. Users are informed that the test is invalid if a line fails to appear in the control region. External controls are not supplied with this device.

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d. Detection limit:

See cutoff section below.

e. Analytical specificity:

The Rapid Tox Cup was evaluated for interference. A high concentration stock solution of each analyte was serially diluted (1:1) until negative results were obtained. The lowest concentrations that gave positive results are listed as the cross-reacting concentration in the package insert.

Amphetamine-500 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  d-amphetamine | 500  |
|  d,l-amphetamine | 500  |
|  l-amphetamine | 20,000  |
|  Phentermine (α,α-dimethiphenethylamine) | 1250  |
|  (+/-)-Methyenedioxyamphetamine | 750  |

Amphetamine -1000 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  d-amphetamine | 1000  |
|  d,l-amphetamine | 1000  |
|  l-amphetamine | 20,000  |
|  Phentermine (α,α-dimethiphenethylamine) | 1250  |
|  (+/-)-Methyenedioxyamphetamine | 750  |

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Barbiturates- 300 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Allobarbital | 300  |
|  Amobarbital | 1000  |
|  Aprobarbitol | 150  |
|  Barbital | 1250  |
|  Butabarbital | 750  |
|  Butalbital | 300  |
|  Butehal | 500  |
|  5,5 Diphenylhydantoin | 2500  |
|  Pentobarbital | 300  |
|  Secobarbital | 150  |
|  Tabutal | 75  |

Benzodiazepines- 300 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Alph-hydroxyalprazolam | 10,000  |
|  Alprazolam | 75  |
|  Bromazepam | 400  |
|  Chlordiazepoxide | 150  |
|  Clobazam | 100  |
|  Clonazepam | 300  |
|  Clorazepate | 100  |
|  Desalkylfurazepam | 500  |
|  Desmethyliazepam | 100  |
|  N-desmethylflunitrazepam | 50  |
|  Diazepam | 100  |
|  Estazolam | 100  |
|  Flunitrazepam | 150  |
|  2-hydroxyethylflurazepam | 5000  |
|  4-hydroxynordiazepam | 4000  |
|  Lorazepam | 2200  |
|  Lorazepam glucuronide | 250  |
|  Lormetazepam | 500  |
|  Nitrazepam | 75  |
|  Nordiazepam | 150  |
|  Oxazepam | 300  |
|  Oxazepam glucuronide | 250  |
|  Sulindac | 7500  |
|  Temazepam | 100  |
|  Temazepam Glucuronide | 75  |
|  Triazolam | 1500  |

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Methamphetamine- 500 ng/mL

|  Compound | Conc. (ng/ml)  |
| --- | --- |
|  (+)- methamphetamine | 500  |
|  (+/-)- methamphetamine | 725  |
|  (+/-)-3,4-methylenedioxymethamphetamine (MDMA) | 725  |
|  (+/-)-methylene-n-ethylmethamphetamine (MDEA) | 20,000  |
|  Procaine | 60,000  |
|  Ranitidine | 50,000  |
|  Trimethobezamide | 20,000  |

Methamphetamine 1000 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  (+)- methamphetamine | 500  |
|  (+/-)- methamphetamine | 1000  |
|  (+/-)-3,4-methylenedioxymethamphetamine (MDMA) | 2500  |
|  (+/-)-methylene-n-ethylmethamphetamine (MDEA) | 20,000  |
|  Procaine | 60,000  |
|  Ranitidine | 50,000  |
|  Trimethobezamide | 20,000  |

Buprenorphine 12.5 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Buprenorphine | 12.5  |
|  Buprenorphine glucuronide | 10  |
|  Codeine | 10000  |
|  Hydrocodone | 25000  |
|  Lysergic Acid Diethylamide (LSD) | 50000  |
|  Metoclopramide | 50000  |
|  Morphine | 25000  |
|  Nalmefene | 75000  |
|  Nalophine | 100  |
|  Norbuprenorphine | 10000  |
|  Norbuprenorphine glucuronide | 10000  |

Cocaine- 150 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Benzoylecgonine | 300  |
|  Cocaethylene | 300  |
|  Cocaine | 100  |
|  Metoclopromide | 80,000  |
|  Procaine | 75,000  |

Cocaine 300 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Benzoylecgonine | 300  |

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Cocaethylene 300
Cocaine 100
Metoclopromide 80,000
Procaine 75,000

THC 50 ng/mL
**Compound** Conc. (ng/mL)
11-hydoxy-delta-9-THC 5000
11-nor-D8-carboxy-delta-9-THC 50
11-nor-D9-carboxy-delta-9-THC 50
11-nor-D9-tetrahydrocannabinol-9-carboxylic acid glucuronide 2500
Delta-8-tetrahydrocannabinol 20,000
Delta-9-tetrahydrocannabinol 20,000

Opiates- 300 ng/mL
**Compound: Opiates 300** Conc. (ng/mL)
6-acetyl morphine 500
Codeine 100
Eserine 15,000
Ethylmorphine 100
Heroin 500
Hydromorphone 2000
Hydrocodone 1250
Morphine 300
Morphine-3-Glucuronide 75
Nalorphine 500
Norcodeine 35,000
Oxycodone 75,000
Thebaine 13,000

Opiates- 2000 ng/mL
**Compound: Opiates 2000** Conc. (ng/mL)
6-acetyl morphine 1000
Codeine 800
Ethylmorphine 400
Heroin 10,000
Hydromorphone 2000
Hydrocodone 5000
Morphine 1600
Morphine-3 Glucuronide 2000
Oxycodone 50,000
Thebaine 26,000

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Oxycodone-100 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  6-Acetylcodeine | 25,000  |
|  6-Acetylmorphine | 75,000  |
|  Codeine | 12,000  |
|  Dihydromorphone | 3,125  |
|  Hydromorphone | 2,500  |
|  Hydrocodone | 625  |
|  Morphine | 6250  |
|  Noroxycodone | 50,000  |
|  Oxycodone | 100  |
|  Oxymorphone | 100  |
|  Thebaine | 25,000  |

Methadone- 300 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Benzotropine Methane Sulfonate | 30,000  |
|  Diphenhydramine | 50,000  |
|  Disopyramide | 60,000  |
|  Isopropamide | 500  |
|  Methadone | 300  |
|  (-)-alpha-Methadol | 300  |
|  (-)-alpha-Acetylmethadol (LAAM) | 2,500  |
|  Procyclide | 50,000  |
|  Suxibuzone | 25,000  |

MDMA- 500 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  (+/-)-3,4-methylenedioxymethamphetamine MDMA | 500  |
|  (+/-)-methamphetamine | 500  |
|  (+)-methamphetamine | 500  |
|  (+/-)-3,4-methylene-n-ethylmethaphetamine (MDEA) | 20,000  |
|  Procaine | 50,000  |
|  Ranitidine | 40,000  |
|  Trimethobenzamide | 20,000  |

MDMA 1000 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  (+)- methamphetamine | 500  |
|  (+/-)- methamphetamine | 1000  |
|  (+/-)-3,4-methylenedioxymethamphetamine (MDMA) | 1000  |
|  (+/-)-methylene-n-ethylmethamphetamine (MDEA) | 20,000  |
|  Procaine | 60,000  |
|  Ranitidine | 50,000  |
|  Trimethobezamide | 20,000  |

{14}

15

TCA 1000 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Amitriptyline | 1000  |
|  Clomipramine | 75000  |
|  Cyclobenzaprine | 8000  |
|  Cyproheptadine | 50,000  |
|  Desipramine | 1000  |
|  Doxepin | 5000  |
|  Imipramine | 1000  |
|  Norclomipramine | 2500  |
|  Nordoxepin | 500  |
|  Nortriptyline | 1000  |
|  Promazine | 12,500  |
|  Protriptyline | 2000  |
|  Trimipramine | 3000  |

Prophoxyphene/Norpropoxyphene- 300 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Propoxyphene | 300  |
|  Norpropoxyphene | 300  |

Phencyclidine- 25 ng/mL

|  Compound | Conc. (ng/mL)  |
| --- | --- |
|  Phencyclidine | 25  |
|  4-hydroxyphencyclidine | 90  |
|  Phencyclidine Morpholine | 625  |

f. Assay cut-off:

The Rapid Tox Cup is designed to detect the concentrations listed in the indications for use section H.2. Ten determinations were made at each concentration of each single analyte. Sensitivity was defined as the lowest concentration of drug that produced positive results in all 10 replicates.

Amphetamine- 500 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  250 | 10 | 0 | 10  |
|  400 | 10 | 1 | 9  |
|  500 | 10 | 10 | 0  |
|  625 | 10 | 10 | 0  |

{15}

16

Amphetamine-1000 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  500 | 10 | 0 | 10  |
|  850 | 10 | 1 | 9  |
|  1000 | 10 | 10 | 0  |
|  1250 | 10 | 10 | 0  |

Barbiturates- 300 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  150 | 10 | 0 | 10  |
|  225 | 10 | 0 | 10  |
|  300 | 10 | 10 | 0  |
|  375 | 10 | 10 | 0  |

Benzodiazepines- 300 ng/mL of oxazepam

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  150 | 10 | 0 | 10  |
|  225 | 10 | 0 | 10  |
|  300 | 10 | 10 | 0  |
|  375 | 10 | 10 | 0  |

Methamphetamine-500 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  250 | 10 | 0 | 10  |
|  375 | 10 | 0 | 10  |
|  500 | 10 | 10 | 0  |
|  625 | 10 | 10 | 0  |

Methamphetamine- 1000 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  500 | 10 | 0 | 10  |
|  750 | 10 | 0 | 10  |
|  1000 | 10 | 10 | 0  |
|  1250 | 10 | 10 | 0  |

{16}

Buprenorphine- 12.5 ng/mL of buprenorphine

|  Conc. ng/mL | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No Drug | 10 | 0 | 10  |
|  2.5 | 10 | 0 | 10  |
|  5.0 | 10 | 0 | 10  |
|  7.5 | 10 | 0 | 10  |
|  10.0 | 10 | 1 | 9  |
|  12.5 | 10 | 10 | 0  |
|  15.0 | 10 | 10 | 0  |

Cocaine-150 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  75 | 10 | 0 | 10  |
|  120 | 10 | 1 | 9  |
|  150 | 10 | 10 | 0  |
|  187 | 10 | 10 | 0  |

Cocaine- 300 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  150 | 10 | 0 | 10  |
|  225 | 10 | 0 | 10  |
|  300 | 10 | 10 | 0  |
|  375 | 10 | 10 | 0  |

THC- 50 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  25 | 10 | 0 | 10  |
|  38 | 10 | 0 | 10  |
|  50 | 10 | 10 | 0  |
|  75 | 10 | 10 | 0  |

Opiates- 300 ng/mL

|  Conc. Morphine (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  150 | 10 | 0 | 10  |
|  225 | 10 | 0 | 10  |
|  300 | 10 | 10 | 0  |
|  375 | 10 | 10 | 0  |

{17}

Opiates 2000 ng/mL

|  Conc. Morphine (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  1000 | 10 | 0 | 10  |
|  1500 | 10 | 0 | 10  |
|  2000 | 10 | 10 | 0  |
|  2500 | 10 | 10 | 0  |

Oxycodone 100 ng/mL

|  Drug Concentration (ng/mL) | # | #Positive | #Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  50 | 10 | 0 | 10  |
|  75 | 10 | 0 | 10  |
|  100 | 10 | 10 | 0  |
|  125 | 10 | 10 | 0  |

Methadone 300 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  150 | 10 | 0 | 10  |
|  225 | 10 | 0 | 10  |
|  300 | 10 | 10 | 0  |
|  375 | 10 | 10 | 0  |

MDMA- 500 ng/mL

|  Conc. (ng/mL) | # | #Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  250 | 10 | 0 | 10  |
|  375 | 10 | 0 | 10  |
|  500 | 10 | 10 | 0  |
|  625 | 10 | 10 | 0  |

MDMA- 1000 ng/mL

|  Conc. (ng/mL) | # | #Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  500 | 10 | 0 | 10  |
|  800 | 10 | 1 | 9  |
|  1000 | 10 | 10 | 0  |
|  1250 | 10 | 10 | 0  |

{18}

TCA- 1000 ng/mL of nortriptyline

|  Concentration (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  500 | 10 | 0 | 10  |
|  750 | 10 | 0 | 10  |
|  1000 | 10 | 10 | 0  |
|  1250 | 10 | 10 | 0  |

Propoxyphene 300 ng/mL

|  Conc. (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  No drug present | 10 | 0 | 10  |
|  150 | 10 | 0 | 10  |
|  225 | 10 | 0 | 10  |
|  300 | 10 | 10 | 0  |
|  375 | 10 | 10 | 0  |

PCP 25 ng/mL

|  Phencyclidine (ng/mL) | # | # Positive | # Negative  |
| --- | --- | --- | --- |
|  0 | 10 | 0 | 10  |
|  13 | 10 | 0 | 10  |
|  19 | 10 | 1 | 9  |
|  25 | 10 | 10 | 0  |
|  37 | 10 | 10 | 0  |

2. Comparison studies:

a. Method comparison with predicate device:

Clinical urine specimens were obtained from a reference laboratory and tested using the Rapid Tox Cup, Gas Chromatography Mass Spectrometry (GC/MS), HPLC for tricyclics antidepressant and LC/MS for buprenorphine. Butalbital, phenobarbital, and pentobarbital samples were evaluated for barbiturates. Alprazolam, oxazepam, lorazepam, nordiazepam, and temazepam samples were evaluated for benzodiazepines. Amitriptyline, nortriptyline, imipramine and desipramine samples were included in the tricyclic antidepressant analysis. Buprenorphine samples were tested via an enzymatic hydrolysis method, followed by centrifugation and direct analysis of the total buprenorphine concentration.

19

{19}

|   | Candidate Device Results | No drug present | Negative (by predicate device or less than 50% 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) | % Agree-ment  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Amp 500 ng/mL | Positive |  | 0 | 4 | 24 | 16 | 100%  |
|   |  Negative | 50 | 15 | 24 | 0 | 0 | 91%  |
|  Amp 1000 ng/mL | Positive |  | 0 | 7 | 21 | 19 | 100%  |
|   |  Negative | 50 | 13 | 21 | 0 | 0 | 83%  |
|  Bar 300 ng/mL | Positive |  | 0 | 3 | 11 | 34 | 100%  |
|   |  Negative | 50 | 16 | 12 | 0 | 0 | 90%  |
|  Benzo 300 ng/mL | Positive |  | 0 | 7 | 13 | 27 | 100%  |
|   |  Negative | 50 | 15 | 21 | 0 | 0 | 84%  |
|  Methamp 500 ng/mL | Positive |  | 0 | 4 | 22 | 30 | 100%  |
|   |  Negative | 50 | 6 | 16 | 0 | 0 | 84%  |
|  Methamp 1000 ng/mL | Positive |  | 0 | 8 | 14 | 26 | 100%  |
|   |  Negative | 50 | 10 | 26 | 0 | 0 | 82%  |
|  Bupren 12.5 ng/mL | Positive |  | 0 | 6 | 11 | 30 | 100%  |
|   |  Negative | 50 | 13 | 20 | 0 | 0 | 85%  |
|  COC 150 ng/mL | Positive |  | 0 | 7 | 11 | 33 | 100%  |
|   |  Negative | 50 | 17 | 15 | 0 | 0 | 82%  |
|  COC 300 ng/mL | Positive |  | 0 | 4 | 15 | 30 | 100%  |
|   |  Negative | 50 | 15 | 17 | 0 | 0 | 89%  |
|  THC 50 ng/mL | Positive |  | 0 | 4 | 17 | 27 | 100%  |
|   |  Negative | 50 | 15 | 17 | 0 | 0 | 89%  |
|  Opiate 300 ng/mL | Positive |  | 0 | 1 | 10 | 50 | 100%  |
|   |  Negative | 50 | 11 | 8 | 0 | 0 | 95%  |
|  Opiate 2000 ng/mL | Positive |  | 0 | 11 | 12 | 28 | 100%  |
|   |  Negative | 50 | 29 | 19 | 0 | 0 | 81%  |
|  Oxycodone 100 ng/mL | Positive |  | 0 | 1 | 9 | 37 | 100%  |
|   |  Negative | 50 | 10 | 13 | 0 | 0 | 93%  |
|  Methadone 300 ng/mL | Positive |  | 0 | 7 | 10 | 30 | 100%  |
|   |  Negative | 50 | 22 | 14 | 0 | 0 | 84%  |
|  MDMA 500 ng/mL | Positive |  | 0 | 8 | 9 | 31 | 100%  |
|   |  Negative | 50 | 16 | 15 | 0 | 0 | 80%  |
|  MDMA 1000 ng/mL | Positive |  | 0 | 9 | 8 | 33 | 100%  |
|   |  Negative | 50 | 6 | 29 | 0 | 0 | 80%  |
|  TCA 1000 ng/mL | Positive |  | 0 | 5 | 15 | 25 | 100%  |
|   |  Negative | 50 | 15 | 17 | 0 | 0 | 86%  |
|  Propoxyphen e 300 ng/mL | Positive |  | 0 | 4 | 7 | 31 | 100%  |
|   |  Negative | 50 | 8 | 14 | 0 | 0 | 85%  |
|  PCP 25 ng/mL | Positive |  | 0 | 4 | 7 | 31 | 100%  |
|   |  Negative | 50 | 8 | 14 | 0 | 0 | 85%  |

b. Matrix comparison:

Not applicable.

{20}

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):
Not applicable.

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.

21

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAG/K073078](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAG/K073078)

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