← Product Code [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG) · K063015

# AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (K063015)

_Ameditech, Inc. · DJG · Dec 20, 2006 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K063015

## Device Facts

- **Applicant:** Ameditech, Inc.
- **Product Code:** [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG.md)
- **Decision Date:** Dec 20, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3650
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an in vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows: Buprenorphine (BUP) 10 ng/ml, Propoxyphene (PPX) 300 ng/ml, Cocaine metabolite (COC150) 150 ng/ml. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional and laboratory use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

## Device Story

Device is a lateral flow immunochromatographic test for qualitative detection of buprenorphine, propoxyphene, and cocaine metabolite in human urine; utilizes competitive binding principle. Input is human urine sample; output is visual colored line indicating presence or absence of drug. Used in professional/laboratory settings; operated by healthcare professionals. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-specific conjugate, forming a visible line (negative result). If drug is present above cutoff, it saturates antibody binding sites, preventing line formation (positive result). Control line confirms proper sample volume and migration. Results are preliminary; requires GC/MS confirmation for clinical decision-making. Benefits include rapid, point-of-care screening for drug abuse.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: card, cassette, cup with drug-specific test strips (50-59 mm). No electronic components; visually read. Internal control line for sample volume/migration. No specific materials or standards cited.

## Regulatory Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An opiate 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).

## 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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

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

A. 510(k) Number:
k063015

B. Purpose of the Submission:
New device

C. Analyte:
Buprenorphine, Propoxyphene, and Cocaine metabolite

D. Type of Test:
Qualitative lateral flow immunochromatographic test, visually read

E. Applicant:
Ameditech, Inc.

F. Proprietary and Established Names:
ImmuTest Multi-Drug Screen BUP/PPX/COC150 (card, cassette, and cup format)

G. Regulatory Information:

1. Regulation section:
862.3650, Enzyme Immunoassay, Opiate test system
862.3700, Enzyme Immunoassay, Propoxyphene test system
862.3250, Enzyme Immunoassay, Cocaine and Cocaine metabolite test system

2. Classification:
Class II, DJG, JXN, DIO

3. Panel:
Toxicology (91)

H. Intended Use:

1. Intended use(s):
See Indications for use below.

2. Indication(s) for use:
The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an in vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows:

|  Test name | Calibrator | Cutoff (ng/ml)  |
| --- | --- | --- |
|  Buprenorphine (BUP) | Buprenorphine | 10  |
|  Propoxyphene (PPX) | Propoxyphene | 300  |

{1}

Cocaine metabolite (COC150)
Benzoylecgonine
150

This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

This test is used to obtain a visual, qualitative result and is intended for professional and laboratory use.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

3. Special condition for use statement(s):

For prescription use only

4. Special instrument Requirements:

Not applicable, as the device is a visually read single-use device.

I. Device Description:

The ImmuTest Multi-Drug Screen BUP/PPX/COC150 consists of drug test strips and a plastic test strip holder. Each test strip detects one drug. The ImmuTest Multi-Drug Screen BUP/PPX/COC150 has three types of test formats: card format (test strips are placed in card strip holders), cassette (test strips are placed in cassette strip holders) and cup format (test strips are placed in lid strip holders). The length of the test strips is 59 mm for cassette and card format, and 50 mm for cup format.

J. Substantial Equivalence Information:

1. Predicate device name(s):

QuikStrip OneStep Buprenorphine Test

ACON One-Step Propoxyphene Test Device

ACON One-Step Cocaine-150 Test Strip

2. Predicate K number(s):

k042988, k040445 and k032903

3. Comparison with predicate:

The device is similar to or the same as the previously cleared predicate(s) in the following ways: test principles, indication for use, cut-off concentrations(s), used in a professional and point-of-care setting and sample matrix. The candidate device and the predicates are both visually-read single use devices.

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

The sponsor did not reference any standards or guidance documents in this submission.

{2}

# L. Test Principle:

The device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of the antibody coated particles on the drug specific test strips. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the control region and the test region. If the sample contains drugs above the cutoff level, a colored line will not appear in the strips test region. Binding of drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. Formation of a colored line in the control region indicates that the proper volume of urine has been added. If a colored line does not appear in the controls region, the test result is inconclusive and should be repeated. The absence or presence of the line is determined visually by the operator.

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

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision was determined by conducting a lot-to-lot precision study and also by conducting a four site precision study.

The lot-to-lot precision study used drug free urine and urine samples containing drug at the cutoff,  $50\%$  below the cutoff,  $25\%$  below the cutoff,  $25\%$  above the cutoff and  $50\%$  above the cutoff. The samples were tested with three lots of the ImmuTest Multi-Drug Screen BUP/PPX/COC150 test format (cassette, card and cup formats) for 3 consecutive days. 10 samples for each of the 6 concentrations were tested daily for each lot. One lot per day for 3 days produced a total of 540 specimens per drug. All samples used were drug free urine spiked with the drugs listed below in the chart. All sample concentrations were confirmed by GC/MS. The results are summarized in the table below:

Table 1: Lot-to-lot assay precision:

|  Drug | Conc. (ng/ml) | Card format |   |   | Cassette format |   |   | Cup format  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Lot 1 (+/-) | Lot 2 (+/-) | Lot 3 (+/-) | Lot 1 (+/-) | Lot 2 (+/-) | Lot 3 (+/-) | Lot 1 (+/-) | Lot2 (+/-) | Lot 3 (+/-)  |
|  BUP Cut-off | 0 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30  |
|   |  5 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30  |
|   |  7.5 | 6/24 | 8/22 | 9/21 | 7/23 | 8/11 | 6/24 | 7/23 | 9/21 | 6/24  |
|   |  10 | 17/13 | 18/12 | 16/14 | 17/13 | 20/10 | 17/13 | 19/11 | 16/14 | 18/12  |
|   |  12.5 | 24/6 | 22/8 | 21/9 | 24/6 | 26/4 | 23/7 | 22/8 | 24/6 | 23/7  |
|   |  15 | 30/0 | 30/0 | 30/0 | 30/0 | 30/0 | 30/0 | 30/0 | 30/0 | 30/0  |
|   | 0 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30 | 0/30  |

{3}

The results from this study showed that the sample solutions at  $0\mathrm{ng / ml}$  (drug-free urine sample) and  $50\%$  below cut-off were all identified as negatives and the sample solutions at  $50\%$  above cut-off were all identified as positives. The results demonstrated that the performance for the cup and cassette devices were same as that for card device.

The assay precision of the ImmuTest Multi-drug screen was also evaluated by different users from 4 sites. Three sites were external and one site was in-house at Ameditech. The testing was conducted for 3 days and totaled 90 samples per drug. All samples used were drug free urine spiked with the drugs listed below in the chart. All sample concentrations were confirmed by GC/MS. The results are summarized in the table below:

Table 2: Four sites precision study

|  Drug | Conc. | VH (+/-) | PVH (+/-) | SM (+/-) | Ameditech (+/-) | Total (+/-)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Buprenorphine | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|  BUP | 5 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 7.5 | 3/12 | 5/10 | 2/13 | 22/68 | 30/105  |
|  Cut-off | 10 | 6/9 | 9/6 | 7/8 | 46/44 | 69/66  |
|   | 12.5 | 11/4 | 12/3 | 11/4 | 66/24 | 98/37  |
|   | 15 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|  Propoxyphene | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|  PPX | 150 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 225 | 4/11 | 3/12 | 4/11 | 20/70 | 31/104  |
|  Cut-off | 300 | 9/6 | 9/6 | 7/8 | 48/42 | 74/61  |
|   | 375 | 12/3 | 11/4 | 10/5 | 63/27 | 100/35  |
|   | 450 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|  Cocaine metabolite | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|  COC150 | 75 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |

{4}

|   | 112.5 | 2/13 | 4/11 | 3/12 | 20/70 | 27/108  |
| --- | --- | --- | --- | --- | --- | --- |
|  Cut-off | 150 | 6/9 | 8/7 | 9/6 | 53/37 | 72/63  |
|   | 187.5 | 10/5 | 11/4 | 12/13 | 66/24 | 101/34  |
|   | 225 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |

The results from this study showed that the sample solutions at 0 ng/ml (drug-free urine sample) and 50% below cut-off were all identified as negatives and the sample solutions at 50% above cut-off were all identified as positives by all study sites.

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

c. Traceability (controls, calibrators, or method):
This device has internal process controls. A visible line appearing in the control region confirms that sufficient sample volume and that the correct technique has been used. In the labeling, users are instructed not to interpret the test if a visible line failed to appear in the control region. Controls are not supplied with this device. The presence of the control line serves as a built-in control, which indicates that the proper sample volume has been used and the reagents are migrating properly.

External controls are available from commercial sources to ensure proper kit performance. In the labeling the sponsor recommends that the external control values are within established limits and if the values of external control do not fall within established limits, the test results are invalid.

d. Detection limit:
Sensitivity of this assay is characterized by validating performance around the claimed cutoff concentration of the assay, including a determination of the lowest concentration of drug that is capable of producing a positive result. The sponsor tested the device to determine the analytical sensitivity at and around the designated cutoff concentrations. Drug free urine and urine samples containing drug at the cutoff, 50% below the cutoff, 25% below the cutoff, 25% above the cutoff and 50% above the cutoff were tested with three lots of the ImmuTest Multi-Drug Screen BUP/PPX/COC150 test format (Cassette card and cup formats) for 3 consecutive days. 10 samples for each of the 6 concentrations were tested daily for each lot. A total of 540 specimens cups were used for three lots, three days testing. All sample concentrations were confirmed by GC/MS analysis. The test results were independently interpreted by two readers. The results are summarized in the table below:

{5}

|  Drug | Conc. (ng/ml) | # Tested | Card Format |   | Cassette Format |   | Cup Format  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  A (+/-) | B (+/-) | A (+/-) | B (+/-) | A (+/-) | B (+/-)  |
|  Buprenorphine | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|  BUP | 5 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|  Cut-off | 7.5 | 90 | 23/67 | 24/66 | 21/69 | 24/66 | 22/68 | 24/66  |
|   |  10 | 90 | 51/39 | 54/36 | 54/36 | 51/39 | 53/37 | 52/38  |
|   |  12.5 | 90 | 67/23 | 75/15 | 73/17 | 71/19 | 69/21 | 70/20  |
|   |  15 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  Propoxyphene | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|  PPX | 150 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|  Cut-off | 225 | 90 | 23/67 | 22/68 | 23/67 | 25/65 | 25/65 | 21/69  |
|   |  300 | 90 | 52/38 | 50/40 | 56/34 | 50/40 | 51/39 | 54/36  |
|   |  375 | 90 | 70/20 | 71/19 | 69/21 | 66/24 | 72/18 | 69/21  |
|   |  450 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  Cocaine metabolite | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|  COC150 | 75 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|  Cut-off | 112.5 | 90 | 24/66 | 23/67 | 27/63 | 24/66 | 23/67 | 22/68  |
|   |  150 | 90 | 52/38 | 52/38 | 52/38 | 54/36 | 52/38 | 56/34  |
|   |  187.5 | 90 | 72/18 | 73/17 | 70/20 | 66/24 | 73/17 | 71/19  |
|   |  225 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |

e. Analytical specificity:

The specificity for the ImmuTest Multi-Drug Screen BUP/PPX/COC150 (cassette format) was determined by testing various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.

The following compounds produce positive results when tested at levels greater than the concentrations listed below.

|  Compound | Concentration (ng/ml)  |
| --- | --- |
|  Buprenorphine |   |
|  Buprenorphine-3-beta-D-glucuronide | 10  |
|  Norbuprenorphine | 7.5  |
|  Norbuprenorphine-3-beta-D-glucuronide | 25,000  |
|  Codeine | 150  |
|  Morphine | >100,000  |

{6}

7

Nalorphine 10,000

## Propoxyphene

D-Propoxyphene 300
D-Norpropoxyphene 300

## Cocaine Metabolite

Benzoylecgonine 150
Cocaine 5,000
Ecgonine >100,000
Cocaethylene >100,000
Ecgonine methyl esters >100,000

## Interference Studies:

The following compounds were evaluated for potential positive and/or negative interference with the Multi-Drug Screen BUP/PPX/COC150 (cassette format). Drug controls at 50% below and 50% above cutoff levels, prepared in the Sensitivity Study section, were used in this study. All compounds were dissolved in the 50% below and 50% above cutoff controls and tested with ImmuTest Multi-Drug Screen BUP/PPX/COC150. An unaltered sample was used as a control. The interferents tested were at concentrations up to 100 µg/mL. The results of the interference study were showed in the tables below.

Results of the positive interference study are presented below:

|  Compound | BUP | PPX | COC150  |
| --- | --- | --- | --- |
|  Unaltered Drug Control | - | - | -  |
|  Acetaminophen | - | - | -  |
|  Acetone | - | - | -  |
|  Albumin | - | - | -  |
|  Ampicillin | - | - | -  |
|  Ascorbic Acid | - | - | -  |
|  Aspartame | - | - | -  |
|  Aspirin | - | - | -  |
|  Atropine | - | - | -  |
|  Benzocaine | - | - | -  |
|  Bilirubin | - | - | -  |
|  Caffeine | - | - | -  |
|  Chloroquine | - | - | -  |
|  (+)-Chlorpheniramine | - | - | -  |
|  (+/-)-Chlorpheniramine | - | - | -  |
|  Creatine | - | - | -  |
|  Dexbrompheniramine | - | - | -  |
|  Dextromethorphan | - | - | -  |

{7}

|  Compound | BUP | PPX | COC150  |
| --- | --- | --- | --- |
|  4-Dimethylaminoantipyrine | - | - | -  |
|  Diphenhydramine | - | - | -  |
|  Dopamine | - | - | -  |
|  (+/-)-Ephedrine | - | - | -  |
|  Erythromycin | - | - | -  |
|  Ethanol | - | - | -  |
|  Furosemide | - | - | -  |
|  Glucose | - | - | -  |
|  Guaiacol Glyceryl Ether | - | - | -  |
|  Hemoglobin | - | - | -  |
|  Ibuprofen | - | - | -  |
|  (+/-)-Isoproterenol | - | - | -  |
|  Ketamine | - | - | -  |
|  Levorphanol | - | - | -  |
|  Lidocaine | - | - | -  |
|  (1R,2S)-(-)-N-Methyl-Ephedrine | - | - | -  |
|  (+)-Naproxen | - | - | -  |
|  Niacinamide | - | - | -  |
|  Nicotine | - | - | -  |
|  (+/-)-Norephedrine | - | - | -  |
|  Oxalic acid | - | - | -  |
|  Penicillin-G | - | - | -  |
|  Pheniramine | - | - | -  |
|  Phenothiazine | - | - | -  |
|  l-Phenylephrine | - | - | -  |
|  β-phenylethylamine | - | - | -  |
|  Procaine | - | - | -  |
|  Quinidine | - | - | -  |
|  Ranitidine | - | - | -  |
|  Riboflavin | - | - | -  |
|  Sodium Chloride | - | - | -  |
|  Sulindac | - | - | -  |
|  Theophylline | - | - | -  |
|  Tyramine | - | - | -  |

Results of the negative interference study are presented below:

|  Compound | BUP | PPX | COC150  |
| --- | --- | --- | --- |
|  Unaltered Drug Control | + | + | +  |
|  Acetaminophen | + | + | +  |
|  Acetone | + | + | +  |
|  Dexamethasone | + | + | +  |
|  Dextrandazole | + | + | +  |
|  Dextrandose | + | + | +  |
|  Dextrandopimel | + | + | +  |
|  Dextrandophorone | + | + | +  |
|  Dextrandophorone | + | + | +  |

{8}

|  Compound | BUP | PPX | COC150  |
| --- | --- | --- | --- |
|  Albumin | + | + | +  |
|  Ampicillin | + | + | +  |
|  Ascorbic Acid | + | + | +  |
|  Aspartame | + | + | +  |
|  Aspirin | + | + | +  |
|  Atropine | + | + | +  |
|  Benzocaine | + | + | +  |
|  Bilirubin | + | + | +  |
|  Caffeine | + | + | +  |
|  Chloroquine | + | + | +  |
|  (+)-Chlorpheniramine | + | + | +  |
|  (+/-)-Chlorpheniramine | + | + | +  |
|  Creatine | + | + | +  |
|  Dexbrompheniramine | + | + | +  |
|  Dextromethorphan | + | + | +  |
|  4-Dimethylaminoantipyrine | + | + | +  |
|  Diphenhydramine | + | + | +  |
|  Dopamine | + | + | +  |
|  (+/-)-Ephedrine | + | + | +  |
|  Erythromycin | + | + | +  |
|  Ethanol | + | + | +  |
|  Furosemide | + | + | +  |
|  Glucose | + | + | +  |
|  Guaiacol Glyceryl Ether | + | + | +  |
|  Hemoglobin | + | + | +  |
|  Ibuprofen | + | + | +  |
|  (+/-)-Isoproterenol | + | + | +  |
|  Ketamine | + | + | +  |
|  Levorphanol | + | + | +  |
|  Lidocaine | + | + | +  |
|  (1R,2S)-(-)-N-Methyl-Ephedrine | + | + | +  |
|  (+)-Naproxen | + | + | +  |
|  Niacinamide | + | + | +  |
|  Nicotine | + | + | +  |
|  (+/-)-Norephedrine | + | + | +  |
|  Oxalic acid | + | + | +  |
|  Penicillin-G | + | + | +  |
|  Pheniramine | + | + | +  |
|  Phenothiazine | + | + | +  |
|  l-Phenylephrine | + | + | +  |
|  β-phenylethylamine | + | + | +  |

{9}

|  Compound | BUP | PPX | COC150  |
| --- | --- | --- | --- |
|  Procaine | + | + | +  |
|  Quinidine | + | + | +  |
|  Ranitidine | + | + | +  |
|  Riboflavin | + | + | +  |
|  Sodium Chloride | + | + | +  |
|  Sulindac | + | + | +  |
|  Theophylline | + | + | +  |
|  Tyramine | + | + | +  |

# Urinary pH studies:

Sample solutions containing drug concentrations that were  $50\%$  above and  $50\%$  below the cutoff used in the sensitivity studies were adjusted for  $\mathsf{pH}$  between the range of 4 to 9 in 1.0 increments using either  $1.0\mathrm{N}$  HCl or  $1.0\mathrm{N}$  NaOH solution. The  $\mathsf{pH}$  adjusted sample solutions were tested in triplicate with the ImmuTest Multi-Drug Screen BUP/PPX/COC150. An unaltered sample was used as a control. The results are summarized in the table below:

|  Drug |  | Unaltered (+/-) | pH 4 (+/-) | pH 5 (+/-) | pH 6 (+/-) | pH 7 (+/-) | pH 8 (+/-) | pH 9 (+/-)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  BUP | (-50%) | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  (+50%) | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  PPX | (-50%) | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  (+50%) | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  COC 150 | (-50%) | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  (+50%) | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |

# Urinary Specific Gravity studies:

Sample solutions containing drug concentrations that were  $50\%$  above and  $50\%$  below the cutoff used in the sensitivity studies were adjusted to specific gravities that ranged from 1.003 to 1.04. Specific Gravity was determined by the weight of the sample solution divided by the volume  $(\mathrm{g / mL})$ . The specific gravity adjusted samples were tested in triplicate with the ImmuTest Multi-Drug Screen BUP/PPX/COC150. An unaltered sample was used as a control. The results are summarized in the table below:

|  Drug |  | Unaltered (+/-) | SG 1.003 (+/-) | SG 1.02 (+/-) | SG 1.03 (+/-) | SG 1.04 (+/-)  |
| --- | --- | --- | --- | --- | --- | --- |
|  BUP | (-50%) | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  (+50%) | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  PPX | (-50%) | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |

{10}

11

|   | (+50%) | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
| --- | --- | --- | --- | --- | --- | --- |
|  COC15 0 | (-50%) | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   | (+50%) | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |

f. Assay cut-off:
The Substance Abuse and Mental Health Services Administration (SAMHSA) has not recommended a cut-off concentration for Buprenorphine and Propoxyphene. The cut-offs for those drugs were chosen based on the levels used by predicate devices. SAMHSA has recommended a cutoff concentration for cocaine metabolite at 300 ng/mL and the ImmuTest Multi-Drug Screen BUP/PPX/COC150 has a cutoff at 150ng/mL for cocaine metabolite. Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section above.

2. Comparison studies:
a. Method comparison with predicate device and GC/MS:

The ImmuTest Multi-Drug Screen BUP/PPX/COC150 device was compared to the commercially available drug screen tests (New Bay Bioresearch QuikStrip One Step BUP test, ACON One-step PPX test, and ACON COC150 One Step Cocaine test). Sixty (60) negative urine samples collected from presumed non-user volunteers were tested by both ImmuTest Multi-Drug Screen BUP/PPX/COC150 and commercially available drug screen tests. Of these negative urine samples tested, all were found negatives by both methods. In a separate study, clinical urine samples obtained from clinical testing laboratories where they were analyzed by GC/MS were tested by both Multi-Drug Screen BUP/PPX/COC150 device and commercially available drug screen tests.

A total of 270 samples were obtained from clinical testing laboratories. An additional 39 diluted samples were also included and were prepared by diluting positive samples with negative urine. This was done in order to obtain more samples near the cutoff concentrations. The results are summarized in the tables below:

Candidate device vs. Predicate device:

|   |   |   | Predicate device |   | % Agreement with Predicate device  |
| --- | --- | --- | --- | --- | --- |
|  Test |   |   | Positive | Negative  |   |
|  BUP | ImmuTest | Positive | 43 | 0 | 100  |
|   |   |  Negative | 0 | 85 | 100  |
|  PPX | ImmuTest | Positive | 68 | 2 | 100  |

{11}

12

|   |  | Negative | 0 | 74 | 97.5  |
| --- | --- | --- | --- | --- | --- |
|  COC150 | ImmuTest | Positive | 68 | 0 | 98.6  |
|   |   |  Negative | 1 | 84 | 100  |

Candidate device vs. GC/MS:

|  ImmuTest Multi-Drug Screen BUP/PPX/CO C150 | GC/MS Negative | GC/MS Near Cutoff Negative (between -50% Cutoff and Cutoff) | GC/MS Near Cutoff Positive (between Cutoff and +50% Cutoff) | GC/MS Positive (greater than +50% Cutoff) | Percent Agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  BUP | 0 | 5-8 ng/mL | 11-15 ng/mL | 16-890 ng/mL | % Agreement  |
|  Positive | 0 | 0 | 8 | 35 | 97.7  |
|  Negative | 18 | 6 | 1 | 0 | 100  |
|  PPX | 0 | 150-250 ng/mL | 310-445 ng/mL | 500-55,752 ng/mL | % Agreement  |
|  Positive | 0 | 0 | 6 | 64 | 98.6  |
|  Negative | 10 | 7 | 1 | 0 | 100  |
|  COC150 | 0 | 75-140 ng/mL | 170-223 ng/mL | 228-33,770 ng/mL | % Agreement  |
|  Positive | 0 | 1 | 7 | 60 | 100  |
|  Negative | 15 | 10 | 0 | 0 | 96.2  |

## b. Matrix comparison:

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

## 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:

No elicit drugs should be present in urine.

## N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

{12}

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

13

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K063015](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K063015)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com