'RAPIDTEC 4' TEST

K041712 · American Bio Medica Corp. · DIS · Nov 3, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041712
• Device Name: 'RAPIDTEC 4' TEST
• Applicant: American Bio Medica Corp.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Nov 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

‘RapidTec 4’ is a one-step, lateral flow immunoassay for the simultaneous detection of four abused substances in urine. ‘RapidTec 4’ is intended for use in the qualitative detection of any four (4) of the following drugs of abuse in human urine at the following levels: (The calibrating analyte is in parentheses) Oxycodone 100 ng/ml (Oxycodone) Benzodiazepines 300 ng/ml (Oxazepam) Barbiturates 300 ng/ml (Butalbital) Methadone 300 ng/ml (Methadone) Propoxyphene 300 ng/ml (Norproxyphene) Tricyclic Antidepressants 1000 ng/ml (Nortriptyline) ‘RapidTec 4’ is intended for professional use. It is not intended for over-the-counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. This immunoassay 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.)

Device Story

RapidTec 4 is a single-strip, lateral flow, competitive immunoassay for simultaneous qualitative detection of four drugs of abuse in human urine. Device operates via visual interpretation of test lines; intended for professional use in clinical settings to screen for oxycodone, benzodiazepines, barbiturates, methadone, propoxyphene, or tricyclic antidepressants. Input is a urine sample; output is a visual qualitative result (positive/negative). Preliminary results indicate need for confirmatory testing (GC/MS or HPLC). Device assists healthcare providers in identifying potential substance use, facilitating clinical decision-making regarding further diagnostic testing or patient management.

Clinical Evidence

No clinical data. Performance established via bench testing, including precision/reproducibility studies (n=40-80 per concentration) and method comparison studies against EMIT II (screening) and GC/MS or HPLC (confirmation) using 90 clinical specimens per analyte.

Technological Characteristics

Lateral flow immunoassay; single-strip form factor; qualitative visual readout. No instrumentation required. Detects drugs at industry-standard cutoff concentrations (100-1000 ng/ml).

Indications for Use

Indicated for professional use in the qualitative screening of human urine for four of six specified drugs of abuse (oxycodone, benzodiazepines, barbiturates, methadone, propoxyphene, or tricyclic antidepressants) at defined cutoff concentrations. Not for over-the-counter sale; requires professional supervision. Provides preliminary results only; requires confirmatory testing (e.g., GC/MS).

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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

• RapidTec 5A (K021114)
• RapidTec 5M (K023869)

Submission Summary (Full Text)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k041712

B. Purpose of the Submission:
New 510(k)

C. Analyte:
- Oxycodone
- Benzodiazepines
- Barbiturates
- Methadone
- Propoxyphene
- Tricyclic Antidepressants

D. Type of Test:
Qualitative immunoassay

E. Applicant:
American Bio Medica

F. Proprietary and Established Names:
‘RapidTec 4’

G. Regulatory Information:
1. Regulation section:
862.3150, Enzyme Immunoassay, Barbiturate
862.3170, Enzyme Immunoassay, Benzodiazepine
862.3620, Enzyme Immunoassay, Methadone
862.3650, Enzyme Immunoassay, Opiates
862.3700, Enzyme Immunoassay, Propoxyphene
862.3910, Thin Layer Chromatography, Tricyclic Antidepressant Drugs
2. Classification:
All Class II
3. Product Code:
DIS; JXM; DJR; DJG; JXN; LFG
4. Panel:
Toxicology (91)

{1}

Page 2 of 15

# H. Intended Use:

1. Intended use(s):
Refer to Indications for use.

2. Indication(s) for use:
‘RapidTec 4’ is a one-step, lateral flow immunoassay for the simultaneous detection of four abused substances in urine. ‘RapidTec 4’ is intended for use in the qualitative detection of any four (4) of the following drugs of abuse in human urine at the following levels: (The calibrating analyte is in parentheses)

| Oxycodone | 100 ng/ml | (Oxycodone) |
| --- | --- | --- |
| Benzodiazepines | 300 ng/ml | (Oxazepam) |
| Barbiturates | 300 ng/ml | (Butalbital) |
| Methadone | 300 ng/ml | (Methadone) |
| Propoxyphene | 300 ng/ml | (Norproxyphene) |
| Tricyclic Antidepressants | 1000 ng/ml | (Nortriptyline) |

‘RapidTec 4’ is intended for professional use. It is not intended for over-the-counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. This immunoassay 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.)

3. Special condition for use statement(s):
‘RapidTec 4’ 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.

The assay is for Rx use.

The assay was not evaluated in point-of-care settings.

4. Special instrument Requirements:
None

I. Device Description:
‘RapidTec 4’ is a single strip for the rapid, visual competitive immunoassay for the simultaneous detection of 4 drugs selected from the following: oxycodone, benzodiazepines, barbiturates, propoxyphene, tricyclic antidepressants and methadone in urine.

{2}

Page 3 of 15

## J. Substantial Equivalence Information:

1. Predicate device name(s):
RapidTec 5A; RapidTec 5M

2. Predicate K number(s):
K021114; K023869

3. Comparison with predicate:
The devices and their predicates are for the qualitative determination of the same analyte(s) in the same matrix, and utilize the same cutoff concentrations. All are visually-read single use devices.

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

The sponsor did not identify any in the submission

## L. Test Principle:

Lateral flow immunoassay

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

1. Analytical performance:

a. Precision/Reproducibility:

**OXYCODONE**

Reproducibility studies were carried out using commercially available standards. Each sample, at each concentration of oxycodone, was tested 4 times, twice daily, for 5 days by 2 different operators at 2 different locations. A total of 80 determinations, at each concentration, were made.

| Concentration (ng/ml) | Total number of Determinations | # Positive | # Negative |
| --- | --- | --- | --- |
| No Drug Present | 80 | 0 | 80 |
| 25 | 80 | 2 | 78 |
| 50 | 80 | 8 | 72 |
| 75 | 80 | 65 | 15 |
| 100 | 80 | 80 | 0 |
| 125 | 80 | 80 | 0 |

## Barbiturates

Reproducibility studies were carried out using commercially available standards. Each sample, at each concentration of butalbital, was tested 4 times, twice daily, for 5 days.

{3}

| Concentration (ng/ml) | Total number of Determinations | Result |
| --- | --- | --- |
| No drug present | 40 | 40 negative |
| 150 | 40 | 40 negative |
| 225 | 40 | 36 positive |
| 300 | 40 | 40 positive |
| 375 | 40 | 40 positive |

# Benzodiazepines

Reproducibility studies were carried out using commercially available standards. Each sample, at each concentration of oxazepam, was tested 4 times, twice daily, for 5 days.

| Concentration (ng/ml) | Total number of Determinations | Result |
| --- | --- | --- |
| No drug present | 40 | 40 negative |
| 150 | 40 | 39 negative |
| 225 | 40 | 36 negative |
| 300 | 40 | 40 positive |
| 375 | 40 | 40 positive |

# Methadone

Reproducibility studies were carried out using commercially available standards. Each sample, at each concentration, was tested 4 times, twice daily for 5 days. A total of 40 determinations were made at each concentration.

| Concentration (ng/ml) | Total number of Determinations | Result |
| --- | --- | --- |
| No drug present | 40 | 40 negative |
| 150 | 40 | 39 negative |
| 225 | 40 | 36 positive |
| 300 | 40 | 40 positive |
| 375 | 40 | 40 positive |

# Propoxyphene

Reproducibility studies were carried out using commercially available control materials. Each sample, at each concentration of norpropoxyphene, was tested 4 times, twice daily for 5 days.

{4}

Page 5 of 15

| Concentration (ng/ml) | Total number of Determinations | Result |
| --- | --- | --- |
| No drug present | 40 | 40 negative |
| 150 ng/ml | 40 | 35 negative |
| 225 ng/ml | 40 | 24 positive |
| 300 ng/ml | 40 | 40 positive |
| 375 ng/ml | 40 | 40 positive |

**Tricyclic Antidepressants**

Studies were carried out using commercially available standards. Each sample, at each concentration of nortriptyline, was tested 4 times, twice daily, for 5 days. A total of 40 determinations, at each concentration, were made.

| Concentration (ng/ml) | Total number of Determinations | # Positive | # Negative |
| --- | --- | --- | --- |
| No drug present | 40 | 0 | 40 |
| 500 | 40 | 0 | 40 |
| 750 | 40 | 32 | 8 |
| 1000 | 40 | 36 | 4 |
| 1250 | 40 | 40 | 0 |

b. Linearity/assay reportable range:
Not applicable. The assay is for qualitative use.

c. Traceability (controls, calibrators, or method):
Traceability is not specified. External controls are commercially available.

d. Detection limit:

**Oxycodone**

'RapidTec 4' will detect 100 ng/ml of oxycodone in urine. Known concentrations of oxycodone were added to certified drug-free urine. Ten (10) determinations were made at each concentration of this single analyte. Sensitivity is defined as the lowest concentration of oxycodone that will produce positive results in all 10 replicates. At 100 ng/ml of oxycodone, all 10 replicates were positive.

{5}

Page 6 of 15

| Concentration (ng/ml) | Result |
| --- | --- |
| No drug present | 10 neg / 10 determinations |
| 50 | 9 neg / 10 determinations |
| 75 | 8 pos / 10 determinations |
| 100 | 10 pos / 10 determinations |
| 125 | 10 pos / 10 determinations |

## Barbiturates

‘RapidTec 4’ detects the presence of 300 ng/ml of butalbital in urine. Known concentrations of butalbital were added to certified drug-free urine and tested with ‘RapidTec4.’ Each concentration was tested ten (10) times. Sensitivity is defined as the lowest concentration of butalbital that produced positive results in all 10 replicates. At 300 ng/ml of butalbital all 10 replicates were positive.

| Concentration (ng/ml) | Total number of Determinations | # Positive | # Negative |
| --- | --- | --- | --- |
| No Drug Present | 10 | 0 | 10 |
| 150 | 10 | 0 | 10 |
| 225 | 10 | 8 | 2 |
| 300 | 10 | 10 | 0 |
| 375 | 10 | 10 | 0 |

## Benzodiazepines

‘RapidTec 4’ will detect 300 ng/ml of oxazepam in urine. Known concentrations of oxazepam were added to certified drug-free urine and tested with ‘RapidTec4.’ Each concentration was tested ten (10) times with ‘Rapid Tec 4.’ Sensitivity is defined as the lowest concentration of oxazepam that produced positive results in all 10 replicates. At 300 ng/ml of oxazepam, all 10 replicates were positive.

| Concentration (ng/ml) | Total number of Determinations | # Positive | # Negative |
| --- | --- | --- | --- |
| No drug present | 10 | 0 | 10 |
| 150 | 10 | 0 | 10 |
| 225 | 10 | 8 | 2 |
| 300 | 10 | 10 | 0 |
| 375 | 10 | 10 | 0 |

## Methadone

‘RapidTec 4’ will detect 300 ng/ml of methadone in urine. Known concentrations of methadone were added to certified drug-free urine.

{6}

Page 7 of 15

Ten (10) determinations were made at each concentration of methadone. Sensitivity is defined as the lowest concentration of methadone that produced positive results in all 10 replicates. At 300 ng/ml of methadone, all 10 replicates were positive.

| Concentration (ng/ml) | Total number of Determinations | # Positive | # Negative |
| --- | --- | --- | --- |
| No drug present | 10 | 0 | 10 |
| 150 | 10 | 1 | 9 |
| 225 | 10 | 7 | 3 |
| 300 | 10 | 10 | 0 |
| 375 | 10 | 10 | 0 |

## Propoxyphene

‘RapidTec 4’ will detect 300 ng/ml of propoxyphene (norpropoxyphene) in urine. Known concentrations of norpropoxyphene were added to certified drug-free urine. Ten (10) determinations were made at each serial dilution of this single metabolite. Sensitivity is defined as the lowest concentration of norpropoxyphene that produced positive results in all 10 replicates. At 300 ng/ml of norpropoxyphene, all 10 replicates produced positive results.

| Concentration (ng/ml) | Total number of Determinations | # Positive | # Negative |
| --- | --- | --- | --- |
| No drug present | 10 | 0 | 10 |
| 150 | 10 | 1 | 9 |
| 225 | 10 | 5 | 5 |
| 300 | 10 | 10 | 0 |
| 375 | 10 | 10 | 0 |

## Tricyclic Antidepressants

‘RapidTec 4’ detects tricyclic antidepressants (nortriptyline) in urine at 1000 ng/ml. Known concentrations of nortriptyline were added to drug-free urine. Ten (10) determinations were made at each serial dilution of this single analyte. Sensitivity is defined as the lowest concentration of nortriptyline that will produce positive results in all 10 replicates. At 1000 ng/ml of nortriptyline, all 10 replicates were positive.

{7}

Page 8 of 15

| Concentration (ng/ml) | Result |
| --- | --- |
| No drug present | 10 neg/10 determinations |
| 500 | 10 neg/10 determinations |
| 750 | 8 pos/10 determinations |
| 1000 | 9 pos/10 determinations |
| 1250 | 10 pos/10 determinations |

e. Analytical specificity:

Cross-reactivity:

Oxycodone

‘RapidTec 4’ detects 300 ng/ml oxazepam in urine. A high concentration stock solution for each of the analytes was serially diluted (1:1) until negative results were obtained. The lowest concentration that gave a positive result was listed as the cross-reactivity concentration.

Compounds that will produce a positive results:

| Compound | Conc. (ng/ml) |
| --- | --- |
| 6-Acetylcodeine | 25,000 |
| 6-Acetylmorphine | 75,000 |
| Codeine | 12,500 |
| Dihydromorphone | 3,125 |
| Hydromorphone | 2,500 |
| Hydrocodone | 625 |
| Morphine | 6,250 |
| Noroxycodone | 50,000 |
| Oxycodone | 100 |
| Oxymorphone | 100 |
| Thebaine | 25,000 |

Barbiturates

‘RapidTec 4’ detects 300 ng/ml butalbital in urine. A high concentration stock solution for each of the analytes was serially diluted (1:1) until negative results were obtained. The lowest concentration that gave a positive result was listed as the cross-reactivity concentration.

{8}

Page 9 of 15

Compounds that will produce a positive results:

| Compound | Conc. (ng/ml) |
| --- | --- |
| Allobarbital | 300 |
| Amobarbital | 1000 |
| Aprobarital | 150 |
| Barbital | 1250 |
| Butabarbital | 750 |
| Butalbital | 300 |
| Butethal | 500 |
| 5,5-Diphenylhydantoin | 2500 |
| Pentobarbital | 300 |
| Phenobarbital | 1500 |
| Secobarbital | 150 |
| Talbutal | 75 |

## Benzodiazepines

‘RapidTec4’ detects 300 ng/ml of oxazepam in urine. A high concentration for each of the analytes was diluted (1:1) until negative results were obtained. The lowest concentration that gave a positive result was listed as the cross-reactivity concentration.

Compounds that will produce a positive result:

| Compound | Conc. (ng/ml) |
| --- | --- |
| Alprazolam | 75 |
| Bromazepam | 400 |
| Chlordiazepoxide | 150 |
| Clobazam | 100 |
| Clonazepam | 300 |
| Desmethyldiazepam | 100 |
| Diazepam | 100 |
| Estazolam | 500 |
| Flunitrazepam | 150 |
| Lorazepam | 2200 |
| Lormetazepam | 500 |
| Nitrazepam | 75 |
| Nordiazepam | 150 |
| Oxazepam | 300 |
| Sulindac | 7500 |
| Temazepam | 100 |
| Triazolam | 1500 |

{9}

Page 10 of 15

# Methadone

‘RapidTec 4’ detects 300 ng/ml of methadone in urine. A high concentration stock solution for each of the analytes was serially diluted (1:1) until negative results were obtained. The lowest concentration that gave a positive result was listed as the cross-reactivity concentration.

Compounds that will give a positive result:

| Compound | Conc. (ng/ml) |
| --- | --- |
| Benzotropine Methane Sulfonate | 30000 |
| Diphenhydramine | 50000 |
| Diisopyramide | 60000 |
| Isopropamide | 500 |
| Methadone | 300 |
| (-)-alpha-Methadol | 300 |
| (-)-alpha-Acetylmethadol (LAAM) | 2500 |
| Procyclide | 50000 |
| Suxibuzone | 25000 |

# Propoxyphene

‘RapidTec 4’ detects 300 ng/ml propoxyphene/norpropoxyphene in urine. A high concentration stock solution of each of the analytes was serially diluted (1:1) until negative results were obtained. The lowest concentration that gave a positive result was listed as the cross-reactivity concentration.

Compounds that will produce a positive result:

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

# Tricyclic Antidepressanta

‘RapidTec 4’ detects 1000 ng/ml of nortriptyline in urine. A high concentration stock solution for each of the analytes as serially diluted (1:1) until negative results were obtained. The lowest concentration that gave a positive result was listed as the cross-reactivity concentration

{10}

Page 11 of 15

Compounds that will produce a positive result:

| Compound | Conc. (ng/ml) |
| --- | --- |
| Amitriptyline | 1000 |
| Clomipramine | 5000 |
| Cyclobenzaprine | 8000 |
| Cyproheptadine | 50000 |
| Desipramine | 800 |
| Doxepin | 5000 |
| Imipramine | 1000 |
| Norclomipramine | 2500 |
| Nordoxepin | 500 |
| Nortriptyline | 1000 |
| Promazine | 12500 |
| Protriptyline | 2000 |
| Trimipramine | 3000 |

Interference:
Studies were conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or dugs positive urine. The compounds were found not to interfere at concentration up to 100,000 ng/ml are listed in package insert.

f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the detection limit section, above. The identified cutoff concentration of the assay is standard for the industry.

2. Comparison studies:

a. Method comparison with predicate device:

Oxycodone
Ninety (90) specimens were tested with ‘RapidTec 4’. Of the 90 samples, 50 were found to be drug-free and 40 were screened as positive by EMIT II. ‘RapidTec 4’ correctly identified all of the specimens that contained no drug as negative. The 40 specimens (19 clinical samples, 21 diluted samples with concentrations near the cutoff), screened as positive by EMIT II, confirmed and quantified by GC/MS for presence of oxycodone, ranged in concentration from 40 to 1025 ng/ml. All specimens containing 54 ng/ml or greater were found to be positive by ‘RapidTec 4.’

{11}

Page 12 of 15

| RapidTec4 | Negative by EMIT II | Near cutoff Negative (between – 50% and cutoff) | Near cutoff Positive (between cutoff and +50%) | GC/MS Positive (greater than +50%) | Percent Agreement |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 7 | 1 | 30 | 82 |
| Negative | 50 | 2 | 0 | 0 | 100 |

## Barbiturates

Ninety (90) clinical specimens were tested with ‘RapidTec 4’. Of the 90 samples, 50 were found to be drug-free and 40 screened as positive by EMIT II. ‘RapidTec 4’ correctly identified all of the specimens that contained no drug as negative. GC/MS analyses of the 40 positive specimens (15 clinical samples, 25 diluted samples with concentrations near the cut-off) showed barbiturate (Alprazolam, Nordiazepam, Oxazepam, and Temazepam) concentrations of 114 to 3034/ml. All specimens containing barbiturate concentrations greater than 180 ng/ml were found to be positive by ‘RapidTec 4.’

| RapidTec4 | Negative by EMIT II | Near cutoff Negative (between – 50% and cutoff) | Near cutoff Positive (between cutoff and +50%) | GC/MS Positive (greater than 50%) | Percent Agreement |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 6 | 8 | 22 | 83 |
| Negative | 50 | 2 | 0 | 0 | 100 |

## Benzodiazepines

Ninety (90) specimens were tested with ‘RapidTec 4.’ Of the 90 specimens, 50 were found to be drug-free and 40 screened as positive by EMIT II. ‘RapidTec 4’ correctly identified all of the specimens that contained no drug as negative. GC/MS analyses of the 40 positive specimens (14 clinical samples, 26 diluted samples with concentrations near the cut-off) showed benzodiazepine (Butalbital, Phenobarbital, Pentobarbital) concentrations of 100 to 3000 ng/ml. The specimens containing 100 to 125 ng/ml were determined to be negative by ‘RapidTec 4.’ All other specimens containing greater than 150 ng/ml of benzodiazepines were shown to be positive.

{12}

Page 13 of 15

| RapidTec4 | Negative by EMIT II | Near cutoff Negative (between-50% and cutoff) | Near cutoff Positive (between cutoff and +50%) | GC/MS Positive (greater than +50%) | Percent Agreement |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 15 | 5 | 15 | 57 |
| Negative | 50 | 2 | 0 | 0 | 100 |

## Methadone

Ninety (90) specimens were tested with ‘RapidTec 4.’ Of the 90 specimens, 50 were found to be drug-free and 40 were screened as positive by EMIT II. ‘RapidTec 4’ correctly identified all of the specimens that contained no drug as negative. GC/MS analyses of the 40 positive specimens (30 clinical samples, 10 dilutes samples with concentrations near the cut-off) showed methadone concentrations of 75 to 1072 ng/ml. All specimens containing 174 ng/ml of methadone or greater were found to be positive by ‘RapidTec 4.’

| RapidTec4 | Negative by EMIT II | Near cutoff Negative (between -50% and cutoff) | Near cutoff Positive (between cutoff and +50%) | GC/MS Positive (greater than +50%) | Percent Agreement |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 8 | 7 | 31 | 82 |
| Negative | 56 | 6 | 0 | 0 | 100 |

## Propoxyphene

Ninety (90) specimens were tested with ‘RapidTec 4’ Of the 90 specimens, 50 were found to be drug-free and 40 were screened as positive by EMIT II. ‘RapidTec 4’ correctly identified all of the specimens that contained no drug as negative. The 40 specimens, screened as positive by EMIT II, confirmed and quantified by GC/MS, showed propoxyphene/norpropoxyphene concentrations of 143 to 621 ng/ml. All specimens containing 233 ng/ml or greater, were found to be positive by ‘RapidTec 4.’ The 9 specimens that contained levels of propoxyphene/norpropoxyphene below 213 ng/ml were determined to be negative by ‘RapidTec 4.’

{13}

Page 14 of 15

| RapidTec4 | Negative by EMIT II | Near cutoff Negative between – 50% and cutoff) | Near cutoff Positive (between cutoff and +50%) | GC?MS Positive (greater than +50%) | Percent Agreement |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 7 | 12 | 22 | 83 |
| Negative | 50 | 2 | 7 | 0 | 89 |

**Tricyclic Antidepressants**

Ninety (90) clinical specimens were tested with ‘Rapid Tec 4.’ Of these, 50 were shown to be drug-free and 40 were screened as positive by EMIT II. Confirmation (identification, but not quantification) was accomplished by HPLC. ‘RapidTec 4’ determined the 50 drug-free specimens as negative and identified the 40 specimens that contained tricyclic antidepressants (Amitriptyline, Desipramine, Nortriptyline, Imipramine) as positive.

| | HPLC | | | |
| --- | --- | --- | --- | --- |
| | | + | | - |
| | + | 40 | 0 | 40 |
| RapidTec | | | | |
| | - | 0 | 50 | 50 |

b. **Matrix comparison:**

Not applicable. The assay is intended for only one sample matrix.

3. **Clinical studies:**

a. **Clinical sensitivity:**

Not applicable. Clinical studies are not typically submitted for this device type.

b. **Clinical specificity:**

Not applicable. Clinical studies are not typically submitted for this device type.

c. **Other clinical supportive data (when a and b are not applicable):**

4. **Clinical cut-off:**

Not applicable.

5. **Expected values/Reference range:**

Not applicable.

{14}

Page 15 of 15

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.