IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST

K121231 · Ind Ndiagnostic, Inc. · NGT · Jul 30, 2012 · General Hospital

Device Facts

• Record ID: K121231
• Device Name: IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
• Applicant: Ind Ndiagnostic, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Jul 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Indications for Use

The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. It is intended for overthe-counter use. The test is intended for over-the counter (OTC) use as the first step in a two step process to provide consumers with information concerning the presence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS (Gas Chromatography / Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Rapid chromatographic immunoassay for qualitative drug detection in human urine; utilizes competitive inhibition principle. Input: urine sample applied to test strip or cassette well. Operation: capillary action moves sample across membrane; drug-conjugate competes with urine-borne drug for limited antibody-colloid gold binding sites. Output: visual pink line formation; presence of line indicates negative result (no drug detected); absence of line indicates positive result (drug present). Used in home setting by lay users. Provides preliminary results only; requires professional confirmatory testing (GC/MS) for clinical decision-making. Benefits: provides consumers with immediate information regarding potential drug presence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rapid chromatographic immunoassay; lateral flow cassette or strip format. Qualitative detection based on competitive binding. No electronic components, software, or external energy sources.

Indications for Use

Indicated for OTC qualitative detection of Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. Intended as a preliminary screening tool for consumers; requires confirmatory testing via GC/MS.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k121231

B. Purpose for Submission:
Addition of the over-the-counter claim to a previously cleared device (k060810)

C. Measurand:
Amphetamine, Cocaine, Methamphetamine, Morphine and Cannabinoids

D. Type of Test:
Qualitative immunoassay

E. Applicant:
IND Diagnostic Inc.

F. Proprietary and Established Names:
IND Drug Home Multi-Panel Test (2-5) – Cassette and Strip Formats
IND Amphetamine Home Test – Cassette and Strip Formats
IND Methamphetamine Home Test – Cassette and Strip Formats
IND Cocaine Home Test – Cassette and Strip Formats
IND Morphine Home Test – Cassette and Strip Formats
IND Marijuana Home Test – Cassette and Strip Formats

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | II | 862.3100 – Amphetamine test system | 91- Toxicology |
| NFY | II | 862.3250 – Cocaine and Cocaine metabolites test system | 91– Toxicology |
| NGG | II | 862.3610 – Methamphetamine test system | 91– Toxicology |
| NGI | II | 862.3640 – Opiate test system | 91– Toxicology |
| NFW | II | 862.3870 – Cannabinoid test system | 91– Toxicology |

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

IND Drug Home Multi-Panel Test (2-5) – Cassette and Strip Formats
IND Amphetamine Home Test – Cassette and Strip Formats
IND Methamphetamine Home Test – Cassette and Strip Formats
IND Cocaine Home Test – Cassette and Strip Formats
IND Morphine Home Test – Cassette and Strip Formats
IND Marijuana Home Test – Cassette and Strip Formats

The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana and Morphine in human urine. It is intended for over-the-counter use.

| Drug Name (code) | Cut-off |
| --- | --- |
| Amphetamine (AMP) | 1000 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Morphine (MOR) | 300 ng/mL |

The test is intended for over-the-counter (OTC) use as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS (Gas Chromatography/Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

3. Special conditions for use statement(s):

For over-the-counter (OTC) use

4. Special instrument requirements:

Not applicable, as the devices are visually-read single-use devices.

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I. Device Description:

The product may be sold as a single test or as part of a panel, and may be packaged in either a strip or a cassette format. Operators dip the test strip into the urine, or add drops of urine to the cassette test well to initiate the test reaction. Results are visually read.

J. Substantial Equivalence Information:

1. Predicate device name(s):

One Step Drugs of Abuse Multi-Panel Test (2-5)
One Step Morphine Test – Cassette and Strip Formats
One Step Cocaine Test - Cassette and Strip Formats
One Step Methamphetamine Test - Cassette and Strip Formats
One Step Amphetamine Test - Cassette and Strip Formats
One Step Marijuana - Cassette and Strip Formats

2. Predicate K number(s):

k060810

3. Comparison with predicate:

| Item | Device | Predicate |
| --- | --- | --- |
| Indication for use | Qualitative detection of drugs-of-abuse in urine | Same |
| Intended Users | Over the Counter (OTC) Use | Prescription Use Only |
| Specimen | Urine | Same |
| Cutoff | Cocaine 300 ng/mL
Methamphetamine 1000 ng/mL
Amphetamine 1000 ng/mL
Morphine 300 ng/mL
Marijuana 50 ng/mL | Same |
| Read time | 5 minutes | 10-20 minutes |
| Storage | 35.6 - 89 °F | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flow immunochromatographic assay based on the principle of antigen antibody immunochemistry | Same |
| Configuration | Strip, cassette and multi-panel | Same |

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

None were referenced

L. Test Principle:

The test is based on the principle of a competitive inhibition immunoassay, in which a chemically labeled drug (drug conjugate) competes with the drug which may be present in urine, for limited antibody binding sites. The test device consists of a membrane strip, which is pre-coated with DOA-BSA conjugate on the test band region, and a colored anti-DOA monoclonal antibody-colloid gold conjugate pad, which is placed at the end of the membrane. In the absence of drug in the urine, the colored antibody-colloid gold conjugate moves with the sample by capillary action along the membrane until it reaches the immobilized drug conjugate in the test band region. At this point, the antibody-colloid gold conjugate reacts with the pre-coated drug conjugate and forms a visible pink colored line as the antibodies form complexes with the drug conjugate. Therefore, formation of a visible pink color line on the test band region is interpreted as a negative test result. When the drug is present in the urine, the drug/metabolite antigen will compete with the drug conjugate coated in the test band region for the limited antibody sites. When a sufficient concentration of drug is present, it will fill the limited antibody binding sites, and will prevent attachment of the colored antibody-colloid gold conjugate to drug conjugates pre-coated in the test band region. Therefore, absence of the pink color band on the test region indicates a positive result for the specified drug. A control line indicates that an adequate volume of sample was added and that the test membrane is intact.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

See performance data from k060810.

b. Linearity/assay reportable range:

Not applicable, the device is intended for qualitative use.

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

See performance data from k060810.

d. Detection limit:

See performance data from k060810.

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e. Analytical specificity:

See performance data from k060810.

f. Assay cut-off:

See performance data from k060810.

## 2. Comparison studies:

a. Method comparison with predicate device:

A lay user study was performed with 100 lay users from three locations: Participants in the study were 43 females and 57 males tested all four devices. They had diverse educational and professional backgrounds and ranged in age from 19 to $>60$ . 270 unaltered urine samples were used with the following concentration; negative, $<50\%$ of the cutoff. $-50\%$ to the cutoff, cutoff to $50\%$ and $>50\%$ of the cutoff. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, for each device 16 blind labeled samples (4 sets of four for each device) and 4 device. The results are summarized below.

| Single Test Strip Format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| THC | Positive | 0 | 0 | 2 | 18 | 19 | 97.4 |
| | Negative | 328 | 10 | 22 | 1 | 0 | 99.4 |
| AMP | Positive | 0 | 0 | 3 | 20 | 21 | 97.6 |
| | Negative | 334 | 8 | 13 | 0 | 0 | 99.2 |
| MET | Positive | 0 | 0 | 2 | 14 | 16 | 96.7 |
| | Negative | 339 | 8 | 20 | 1 | 0 | 99.5 |
| COC | Positive | 0 | 0 | 3 | 19 | 23 | 97.7 |
| | Negative | 323 | 9 | 22 | 0 | 0 | 99.2 |
| MOR | Positive | 0 | 0 | 2 | 16 | 19 | 100 |
| | Negative | 334 | 10 | 19 | 0 | 0 | 99.5 |

Discordant table:

Strip Format

| Sample Number | Viewer result | GC/MS result |
| --- | --- | --- |
| THC-125-13 | Negative | 52 |
| THC-75-5 | Positive | 41 |

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| Single Test Cassette Format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| THC | Positive | 0 | 0 | 2 | 20 | 19 | 100 |
| | Negative | 329 | 9 | 21 | 0 | 0 | 99.4 |
| AMP | Positive | 0 | 0 | 1 | 22 | 25 | 97.9 |
| | Negative | 328 | 5 | 18 | 1 | 0 | 99.7 |
| MET | Positive | 0 | 0 | 2 | 24 | 17 | 97.6 |
| | Negative | 325 | 5 | 26 | 1 | 0 | 99.4 |
| COC | Positive | 0 | 0 | 1 | 23 | 15 | 100 |
| | Negative | 345 | 3 | 13 | 0 | 0 | 99.7 |
| MOR | Positive | 0 | 0 | 1 | 29 | 17 | 95.8 |
| | Negative | 329 | 4 | 18 | 2 | 0 | 99.7 |

Discordant table:

Cassette Format

| Sample Number | Viewer result | GC/MS result |
| --- | --- | --- |
| THC-75-10 | Positive | 46 |
| THC-75-9 | Positive | 49 |
| AMP-75-8 | Positive | 980 |
| AMP-125-5 | Negative | 1012 |
| MET-75-3 | Positive | 943 |
| MET-125-5 | Negative | 1120 |
| MET-75-10 | Positive | 934 |

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| Multi-Panel Strip Format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| THC | Positive | 0 | 0 | 0 | 22 | 14 | 100 |
| | Negative | 332 | 18 | 14 | 0 | 0 | 100 |
| AMP | Positive | 0 | 0 | 1 | 14 | 19 | 97.1 |
| | Negative | 335 | 11 | 18 | 2 | 0 | 99.7 |
| MET | Positive | 0 | 0 | 2 | 18 | 21 | 100 |
| | Negative | 331 | 8 | 20 | 0 | 0 | 99.4 |
| COC | Positive | 0 | 0 | 1 | 16 | 14 | 96.8 |
| | Negative | 340 | 4 | 23 | 1 | 0 | 99.7 |
| MOR | Positive | 0 | 0 | 1 | 28 | 13 | 97.6 |
| | Negative | 328 | 5 | 24 | 1 | 0 | 99.7 |

Discordant table:

Multi-Strip Format

| Sample Number | Viewer result | GC/MS result |
| --- | --- | --- |
| AMP-125-1 | Negative | 1103 |
| AMP-75-7 | Positive | 945 |
| AMP-125-15 | Negative | 1119 |
| MET-75-9 | Positive | 934 |
| MET-75-14 | Positive | 944 |
| COC-75-8 | Positive | 282 |
| COC-125-4 | Negative | 329 |
| MOR-75-13 | Positive | 258 |
| MOR-125-10 | Negative | 313 |

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| Multi-Panel Cassette Format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| THC | Positive | 0 | 0 | 1 | 27 | 13 | 100 |
| | Negative | 339 | 5 | 15 | 0 | 0 | 99.7 |
| AMP | Positive | 0 | 0 | 1 | 26 | 13 | 97.5 |
| | Negative | 338 | 6 | 15 | 1 | 0 | 99.7 |
| MET | Positive | 0 | 0 | 1 | 23 | 17 | 97.6 |
| | Negative | 338 | 3 | 17 | 1 | 0 | 99.7 |
| COC | Positive | 0 | 0 | 2 | 27 | 20 | 95.9 |
| | Negative | 321 | 8 | 20 | 2 | 0 | 99.7 |
| MOR | Positive | 0 | 0 | 1 | 19 | 20 | 100 |
| | Negative | 320 | 11 | 29 | 0 | 0 | 99.7 |

Discordant table:

Multi-Cassette Format

| Sample Number | Viewer result | GC/MS result |
| --- | --- | --- |
| THC-75-11 | Positive | 45 |
| AMP-75-1 | Positive | 976 |
| AMP-125-4 | Negative | 1024 |
| MET-125-14 | Negative | 1106 |
| MET-75-2 | Positive | 901 |
| COC-125-7 | Negative | 314 |
| COC-75-13 | Positive | 297 |
| COC-125-2 | Negative | 321 |
| COC-75-11 | Positive | 293 |
| MOR-75-10 | Positive | 286 |

b. Matrix comparison:

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

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

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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.

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