← Product Code [DIS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS) · K042975

# AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (K042975)

_Ameditech, Inc. · DIS · Dec 29, 2004 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K042975

## Device Facts

- **Applicant:** Ameditech, Inc.
- **Product Code:** [DIS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS.md)
- **Decision Date:** Dec 29, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3150
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Ameditech ImmuTest Multi-Drug Screen Panel II 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 Calibrator Cutoff (ng/ml) Barbiturates (BAR) Secobarbital 300 Benzodiazepines (BZO) Oxazepam 300 3,4methylenedioxymethamphetamine (MDMA) 3,4methylenedioxymethamphetamine 500 Methamphetamine (MET1000) d-Methamphetamine 1000 Methadone (MTD) Methadone 300 Opiates (OPI300) Morphine 300 Oxycodone (OXY) Oxycodone 100 This test has three types of test format: 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 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 seven drugs in human urine; utilizes competitive binding principle. Input is human urine sample; output is visual colored line indicating presence or absence of drug at specific cutoff concentrations. Device available in card, cassette, or cup formats. Used in professional and point-of-care settings; operated by healthcare professionals. Absence of line at test region indicates positive result; presence of line at control region confirms valid test. Provides preliminary results requiring GC/MS confirmation. Benefits include rapid, multi-drug screening capability for clinical decision-making.

## Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data: precision/reproducibility studies (n=540-1080 per drug), cross-reactivity, interference studies (pH 4-9, specific gravity 1.003-1.04), and method comparison against GC/MS and predicate devices (n=642 samples). Agreement with GC/MS ranged from 92.1% to 100% across analytes.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: card, cassette, cup. Visual readout. No electronic components or external energy source. Internal process control line confirms sample volume and technique. No specific materials or standards referenced.

## Regulatory 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).

## Submission Summary (Full Text)

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

A. 510(k) Number:
K042975

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

C. Analyte:
Barbiturates, Benzodiazepines, Methadone, Methylenedioxymethamphetamine (MDMA), Methamphetamine, Opiates (Morphine) and Oxycodone.

D. Type of Test:
Qualitative Lateral Flow Immunochromatographic Test

E. Applicant:
Ameditech, Inc.

F. Proprietary and Established Names: ImmuTest Multi-Drug Screen Panel II

G. Regulatory Information:
1. Regulation section:
862.3150, Enzyme Immunoassay, Barbiturate
862.3170, Enzyme Immunoassay, Benzodiazepine
862.3620, Enzyme Immunoassay, Methadone
862.3610, Thin Layer Chromatography, Methamphetamine
862.3650, Enzyme Immunoassay, Opiates
2. Classification:
II
3. Product Code:
DIS, JXM, DJR, LAF, DJG
4. Panel:
Toxicology (91)

H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
The Ameditech ImmuTest Multi-Drug Screen Panel II 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.

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|  Test | Calibrator | Cutoff (ng/ml)  |
| --- | --- | --- |
|  Barbiturates (BAR) | Secobarbital | 300  |
|  Benzodiazepines (BZO) | Oxazepam | 300  |
|  3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500  |
|  Methamphetamine (MET1000) | d-Methamphetamine | 1000  |
|  Methadone (MTD) | Methadone | 300  |
|  Opiates (OPI300) | Morphine | 300  |
|  Oxycodone (OXY) | Oxycodone | 100  |

This test has three types of test format: 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 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):
See Indications for Use statement Above.

4. Special instrument Requirements:
Not applicable, as the device is a visually read single-use device.

I. Device Description:
The ImmuTest Multi-Drug Screen Panel II consists of several single-use drug test strips that are used in one of three formats: card, cassette and cup format. The strips differ for the cup (50 mm) format and the card and cassette (59 mm) format. Addition of urine initiates the test which employs traditional immunochromatographic technology.

J. Substantial Equivalence Information:

1. Predicate device name(s):
InstaCheck Drug Screen Test BAR, Instacheck Drug Screen Test BZO, InstaCheck Drug Screen Test MDMA, QuickScreen Methamphetamine Test, QuickScreen Opiates Test, QuickScreen One Step Methadone Screening Test and RapidOne OXY.

2. Predicate K number(s):
K990107, K990099, K011133, K000447, K972619, K982938 and K014101.

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

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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.

The essential difference between the device and the predicate devices are that this device allows for multiple drugs to be tested at once and the test time is shorter.

|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Read Time | 5 minutes | 8 minutes  |
|  # of drugs testable | 7 drugs | 1 drug  |

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

The sponsor did not reference any standards in their submission.

## 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 assessed 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 Panel II device (card format) 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. The results are summarized in the table below.

Specimen description: drug free urine spiked with the drugs listed below in the chart.

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Number of days: three
Replicates per day: one
Runs per day: one
Lots of product used: three
Number of operators: one
Operator Education: B.S degree in Chemistry
Testing Facility: Ameditech

Results of the studies are presented below-

|  Drug | Conc (ng/mL) | Total # Tested | Lot 1 (+/-) | Lot 2 (+/-) | Lot 3 (+/-)  |
| --- | --- | --- | --- | --- | --- |
|   | 0 | 90 | 0/30 | 0/30 | 0/30  |
|   | 150 | 90 | 0/30 | 0/30 | 0/30  |
|   | 225 | 90 | 7/23 | 9/21 | 6/24  |
|  BAR (Secobarbital) | 300 | 90 | 17/13 | 16/14 | 13/17  |
|   | 375 | 90 | 24/6 | 22/8 | 10/20  |
|   | 450 | 90 | 0/30 | 0/30 | 0/30  |
|   | 0 | 90 | 0/30 | 0/30 | 0/30  |
|   | 150 | 90 | 0/30 | 0/30 | 0/30  |
|   | 225 | 90 | 5/25 | 8/22 | 7/23  |
|  BZO (Oxazepam) | 300 | 90 | 16/14 | 18/12 | 14/16  |
|   | 375 | 90 | 22/8 | 20/10 | 21/9  |
|   | 450 | 90 | 30/0 | 30/0 | 30/0  |
|   | 0 | 90 | 0/30 | 0/30 | 0/30  |
|   | 250 | 90 | 0/30 | 0/30 | 0/30  |
|   | 375 | 90 | 6/24 | 9/21 | 5/25  |
|  MDMA | 500 | 90 | 18/12 | 19/11 | 16/14  |
|  (3,4-methylenedioxy-methamphetamine) | 625 | 90 | 21/9 | 21/7 | 22/8  |
|   | 750 | 90 | 30/0 | 30/0 | 30/0  |
|   | 0 | 90 | 0/30 | 0/30 | 0/30  |
|   | 500 | 90 | 0/30 | 0/30 | 0/30  |
|   | 750 | 90 | 8/22 | 7/23 | 7/23  |
|  MET100 (Methamphetamine) | 1000 | 90 | 14/16 | 17/13 | 19/11  |
|   | 1250 | 90 | 20/10 | 18/12 | 21/9  |
|   | 1500 | 90 | 30/0 | 30/0 | 30/0  |
|   | 0 | 90 | 0/30 | 0/30 | 0/30  |
|   | 150 | 90 | 0/30 | 0/30 | 0/30  |
|   | 225 | 90 | 6/24 | 8/22 | 7/23  |
|  MTD (Methadone) | 300 | 90 | 13/17 | 16/14 | 17/13  |
|   | 375 | 90 | 22/8 | 21/9 | 23/7  |
|   | 450 | 90 | 30/0 | 30/0 | 30/0  |
|   | 0 | 90 | 0/30 | 0/30 | 0/30  |
|   | 150 | 90 | 0/30 | 0/30 | 0/30  |

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In order to show that all three formats of the devices (card, cup and cassette) are equivalent in readability, an additional study was conducted in conjunction with the above precision study. The data showed that all samples with drug concentration of  $50\%$  below cutoff were identified as negatives with card, cassette, and cup test formats. All samples with drug concentration of  $50\%$  above cut-off were identified as positives with all three formats. The chart below incorporates all three formats with the results of both readers.

|  Drug | Conc. (ng/ml) | # Tested | Card Format* |   | Cassette Format |   | Cup Format  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  A (+/-) | B (+/-) | A (+/-) | B (+/-) | A (+/-) | B (+/-)  |
|  BAR (Secobarbital) | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  150 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  225 | 90 | 22/68 | 26/64 | 23/67 | 25/65 | 24/66 | 27/63  |
|   |  300 | 90 | 46/44 | 48/42 | 47/43 | 44/46 | 47/43 | 50/40  |
|   |  375 | 90 | 66/24 | 65/25 | 65/25 | 67/23 | 70/20 | 69/21  |
|   |  450 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  BZO (Oxazepam) | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  150 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  225 | 90 | 20/70 | 23/67 | 24/66 | 21/69 | 26/64 | 23/67  |
|   |  300 | 90 | 48/42 | 47/43 | 45/45 | 47/43 | 49/41 | 51/39  |
|   |  375 | 90 | 63/27 | 61/29 | 59/31 | 60/30 | 65/25 | 62/28  |
|   |  450 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  MDMA | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  250 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  375 | 90 | 20/70 | 22/68 | 19/71 | 22/68 | 23/67 | 26/64  |
|   |  500 | 90 | 53/37 | 49/41 | 50/40 | 49/41 | 54/36 | 51/39  |
|   |  625 | 90 | 66/24 | 65/25 | 65/25 | 67/23 | 70/20 | 68/22  |
|   |  750 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |

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|  MET1000 (Methamphetamine) | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  500 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  750 | 90 | 22/68 | 21/69 | 23/67 | 25/65 | 26/64 | 25/65  |
|   |  1000 | 90 | 50/40 | 48/42 | 46/44 | 44/46 | 50/40 | 49/41  |
|   |  1250 | 90 | 59/31 | 66/24 | 65/25 | 62/28 | 69/21 | 71/19  |
|   |  1500 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  MTD (Methadone) | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  150 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  225 | 90 | 21/69 | 24/66 | 19/71 | 22/68 | 25/65 | 23/67  |
|   |  300 | 90 | 46/44 | 43/47 | 44/46 | 42/48 | 47/43 | 48/42  |
|   |  375 | 90 | 66/24 | 67/23 | 65/25 | 62/28 | 68/22 | 70/20  |
|   |  450 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  OPI300 (Morphine) | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  150 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  225 | 90 | 25/65 | 27/63 | 22/68 | 24/66 | 28/62 | 26/64  |
|   |  300 | 90 | 49/41 | 47/43 | 49/41 | 50/40 | 50/40 | 52/38  |
|   |  375 | 90 | 62/28 | 61/29 | 60/30 | 63/27 | 61/29 | 64/26  |
|   |  450 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |
|  OXY (Oyxcodone) | 0 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  50 | 90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90 | 0/90  |
|   |  75 | 90 | 23/67 | 22/68 | 24/66 | 22/68 | 25/65 | 24/66  |
|   |  100 | 90 | 51/39 | 48/42 | 50/40 | 51/39 | 53/37 | 55/45  |
|   |  125 | 90 | 63/27 | 64/26 | 66/24 | 65/25 | 70/20 | 67/23  |
|   |  150 | 90 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0 | 90/0  |

The results demonstrated that the performance for the cup and cassette devices were same as that for card device.

This card format data from reader A that is in the above study was also included in a 4 site assay study and represented the Ameditech site portion study. The other 3 sites are Vtias Healthcare(VH), Paradise Valley Hospital (PVH), and Scripps Mercy (SM). The additional 3 sites analyzed 5 sample cups per drug concentration listed below. The testing was conducted for 3 days and totaled 90 samples per drug.

|  Drug | Conc (ng/mL) | VH (+/-) | PVH (+/-) | SM (+/-) | Ameditech (+/-) | Total (+/-)  |
| --- | --- | --- | --- | --- | --- | --- |
|   | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 150 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 225 | 2/13 | 4/11 | 2/13 | 22/68 | 30/105  |
|  BAR (Secobarbital) | 300 | 6/9 | 9/6 | 8/7 | 46/44 | 69/66  |

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|   | 375 | 10/5 | 12/3 | 10/5 | 66/24 | 98/37  |
| --- | --- | --- | --- | --- | --- | --- |
|   | 450 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|   | 0 | 90 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 150 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 225 | 4/11 | 2/13 | 5/10 | 20/70 | 31/104  |
|  BZO (Oxazepam) | 300 | 10/5 | 7/8 | 9/6 | 48/42 | 74/61  |
|   | 375 | 14/1 | 12/3 | 11/4 | 63/27 | 100/35  |
|   | 450 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|   | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 250 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 375 | 3/12 | 3/12 | 1/14 | 20/70 | 27/108  |
|  MDMA (3,4-methylenedioxy-methamphetamine) | 500 | 5/10 | 8/7 | 6/9 | 53/37 | 72/63  |
|   | 625 | 12/3 | 12/3 | 11/4 | 66/24 | 101/34  |
|   | 750 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|   | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 500 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 750 | 4/11 | 2/13 | 2/13 | 22/68 | 30/105  |
|  MET100 (Methamphetamine) | 1000 | 9/6 | 7/8 | 8/7 | 50/40 | 74/61  |
|   | 1250 | 13/2 | 12/3 | 11/3 | 59/31 | 96/69  |
|   | 1500 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|   | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 150 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 225 | 2/13 | 4/11 | 5/10 | 21/69 | 32/103  |
|  MTD (Methadone) | 300 | 9/6 | 8/7 | 10/5 | 46/44 | 73/62  |
|   | 375 | 12/3 | 11/4 | 13/2 | 66/24 | 102/33  |
|   | 450 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|   | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 150 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 225 | 4/11 | 2/13 | 2/13 | 25/65 | 33/102  |
|  OPI300 (Morphine) | 300 | 8/7 | 6/9 | 7/8 | 49/41 | 70/65  |
|   | 375 | 11/4 | 10/5 | 12/3 | 62/28 | 95/40  |
|   | 450 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |
|   | 0 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 50 | 0/15 | 0/15 | 0/15 | 0/90 | 0/135  |
|   | 75 | 1/14 | 2/13 | 3/12 | 23/67 | 29/106  |
|  OXY (Oxycodone) | 100 | 7/8 | 7/8 | 6/9 | 51/39 | 71/64  |
|   | 125 | 11/4 | 13/2 | 12/3 | 63/27 | 99/36  |
|   | 150 | 15/0 | 15/0 | 15/0 | 90/0 | 135/0  |

The precision result revealed that the samples that contained  $0\mathrm{ng / mL}$ , or were  $50\%$  below the cut-off were identified at negatives and the samples

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that were 50% above the cut-off were all identified at positives at study sites and with all lots.

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 colored line appearing in the control region confirms that sufficient sample volume and that the correct technique has been used. Users are informed not to interpret the test if a colored 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 demonstrates that the test is performing properly.

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 Panel II device (card format) for 3 consecutive days. 10 samples for each of the 6 concentrations were tested daily for each lot. The 1080 specimens per drug were independently interpreted by 2 readers (540 per reader). The results are summarized in the table below:

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|  Drug | Conc (ng/mL) | # Tested | # Positive | # Negative | % Positive  |
| --- | --- | --- | --- | --- | --- |
|   | 0 | 180 | 0 | 0 | 0%  |
|   | 150 | 180 | 0 | 0 | 0%  |
|   | 225 | 180 | 48 | 132 | 27%  |
|  BAR (Secobarbital) | 300 | 180 | 94 | 86 | 52%  |
|   | 375 | 180 | 131 | 49 | 73%  |
|   | 450 | 180 | 180 | 0 | 100%  |
|   | 0 | 180 | 0 | 0 | 0%  |
|   | 150 | 180 | 0 | 0 | 0%  |
|   | 225 | 180 | 43 | 137 | 24%  |
|  BZO (Oxazepam) | 300 | 180 | 95 | 85 | 53%  |
|   | 375 | 180 | 124 | 56 | 69%  |
|   | 450 | 180 | 180 | 0 | 100%  |
|   | 0 | 180 | 0 | 0 | 0%  |
|   | 250 | 180 | 0 | 0 | 0%  |
|   | 375 | 180 | 42 | 138 | 23%  |
|  MDMA (3,4-methylenedioxy-methamphetamine | 500 | 180 | 102 | 78 | 57%  |
|   | 625 | 180 | 131 | 49 | 73%  |
|   | 750 | 180 | 180 | 0 | 100%  |
|   | 0 | 180 | 0 | 180 | 0%  |
|   | 500 | 180 | 0 | 180 | 0%  |
|   | 750 | 180 | 43 | 137 | 24%  |
|  MET100 (Methamphetamine) | 1000 | 180 | 98 | 82 | 54%  |
|   | 1250 | 180 | 125 | 55 | 69%  |
|   | 1500 | 180 | 180 | 0 | 100%  |
|   | 0 | 180 | 0 | 180 | 0%  |
|   | 150 | 180 | 0 | 180 | 0%  |
|   | 225 | 180 | 45 | 135 | 25%  |
|  MTD (Methadone) | 300 | 180 | 89 | 91 | 49%  |
|   | 375 | 180 | 133 | 47 | 74%  |
|   | 450 | 180 | 180 | 0 | 100%  |
|   | 0 | 180 | 0 | 180 | 0%  |
|   | 150 | 180 | 0 | 180 | 0%  |
|   | 225 | 180 | 52 | 128 | 29%  |
|  OPI300 (Morphine) | 300 | 180 | 96 | 84 | 53%  |
|   | 375 | 180 | 123 | 57 | 68%  |
|   | 450 | 180 | 180 | 0 | 100%  |
|   | 0 | 180 | 0 | 180 | 0%  |
|   | 50 | 180 | 0 | 180 | 0%  |
|   | 75 | 180 | 45 | 135 | 25%  |
|  OXY (Oxycodone) | 100 | 180 | 99 | 81 | 55%  |
|   | 125 | 180 | 127 | 53 | 71%  |
|   | 150 | 180 | 180 | 0 | 100%  |

{9}

# e. Analytical specificity:

# e.1 Cross Reactivity Study

Cross-reactivity was established by spiking various drugs, their metabolites and other compounds likely to be present in urine into drug-free urine. The concentration of the drug/drug metabolites, structure-related compounds standard solution was determined by GC/MS. These solutions were spiked into drug-free urine at a concentration of  $100\mu \mathrm{g / mL}$ , then serially diluted and tested with the ImmuTest Multi-Drug Screen Panel II until the concentration yielded a negative result. Cross-reactivity was calculated by dividing the concentration at which the compound yielded a positive result by the designated cut-off concentration.

Cross-Reactivity = Lowest concentration of the targeted drug that generates a positive result Lowest concentration of compound that generates a positive result

By analyzing various concentrations of each compound, the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table(s) below:

Methamphetamine

|  Drug Compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  d-amphetamine | 50,000 | 100  |
|  l-amphetamine | >100,000 | <1  |
|  d-methamphetamine | 1,000 | 2  |
|  l-methamphetamine | 10,000 | 10  |
|  (-/+) 3,4-Methylenedioxyethylamphetamine(MDEA) | 50,000 | 2  |
|  3,4-Methylenedioxymethamphetamine (MDMA) | 3,000 | 33  |
|  (-/+) 3,4-Methylenedioxyamphetamine (MDA) | 100,000 | 1  |
|  Ephedrine | >100,000 | <1  |
|  Mephentermine | 75,000 | 13  |

Opiates

|  Drug compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  6-Monoacetylmorphine | 350 | 86  |
|  Codeine | 250 | 120  |
|  Heroin | 750 | 40  |

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Page 11 of 20

|  Hydrocodone | 500 | 60  |
| --- | --- | --- |
|  Hydromorphone | 500 | 60  |
|  Morphine | 300 | 100  |
|  Morphine-3-β-glucuronide | 300 | 100  |
|  Ethylmorphine | 300 | 100  |
|  Nalorphine | 5,000 | 6  |

## Barbiturates

|  Compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  Secobarbital | 300 | 100  |
|  Allobarbital | 600 | 50  |
|  Alphenal | 200 | 150  |
|  Amobarbital | 1500 | 20  |
|  Aprobarbital | 300 | 100  |
|  Barbital | 1500 | 20  |
|  Butabarbital | 400 | 75  |
|  Butabital | 300 | 100  |
|  Butethal | 450 | 67  |
|  Pentobarbital | 400 | 75  |
|  Phenobarbital | 450 | 67  |

## Benzodiazepines

|  Compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  Oxazepam | 300 | 100  |
|  Alprazolam | 400 | 75  |
|  Bromazepam | 250 | 120  |
|  Chlordiazepoxide | 300 | 100  |
|  Clobazam | 1000 | 30  |
|  Clonazepam | 500 | 60  |
|  Clonazepate Dipotassium | 150 | 200  |
|  Desalkylflurazepam | 200 | 150  |
|  Diazepam | 450 | 67  |
|  Estazolam | 300 | 100  |
|  Flunitrazepam | 300 | 100  |
|  Flurazepam | 300 | 100  |
|  Lorazepam | 500 | 60  |
|  Medazepam | 300 | 100  |
|  Nitrazepam | 250 | 120  |
|  Nordiazepam | 150 | 200  |
|  Prazepam | 500 | 60  |
|  Temezepam | 200 | 150  |

{11}

# Methadone

|  Compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  (+/-) Methadone | 300 | 100  |
|  Methadol | 1,500 | 20  |

# 3,4-Methylenedioxymethamphetamine

|  Compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  3,4-Methylenedioxymethamphetamine | 500 | 100  |
|  3,4-Methylenedioxyethylamphetamine | 450 | 111  |
|  3,4-methylenedioxyamphetamine | 4,000 | 12.5  |

# Oxycodone

|  Compound | Response equivalent to cutoff in ng/mL | % Cross-Reactivity  |
| --- | --- | --- |
|  Oxycodone | 100 | 100  |
|  Hydrocodone | 5000 | 2  |
|  Hydromorphone | 50000 | 0.2  |
|  Morphine | >100,000 | <0.1  |
|  Codeine | 50,000 | 0.2  |
|  Heroin | >100,000 | <0.1  |

# e.2 Interference Studies

The following compounds were evaluated for potential positive and negative interference with the assay. To evaluate potential interference, the sponsor prepared two urine pools that consisted of drug-free urine spiked with each of the 7 drugs to  $50\%$  below and  $50\%$  above cutoff concentrations. To aliquots of these pools, the sponsor added the potential interferent at a concentration of  $100 \square \mathrm{g} / \mathrm{mL}$ .

Results of the positive interference study are presented below:

|  Compound | BAR | BZO | MDMA | MET | MTD | OPI | OXY  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Control | - | - | - | - | - | - | -  |
|  Acetaminophen | - | - | - | - | - | - | -  |
|  Acetone | - | - | - | - | - | - | -  |

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Page 13 of 20

|  Albumin | - | - | - | - | - | -  |
| --- | --- | --- | --- | --- | --- | --- |
|  Amitriptyline | - | - | - | - | - | -  |
|  Ampicillin | - | - | - | - | - | -  |
|  Ascorbic Acid | - | - | - | - | - | -  |
|  Aspartame | - | - | - | - | - | -  |
|  Aspirin | - | - | - | - | - | -  |
|  Atropine | - | - | - | - | - | -  |
|  Benzocaine | - | - | - | - | - | -  |
|  Bilirubin | - | - | - | - | - | -  |
|  Caffeine | - | - | - | - | - | -  |
|  Chloroquine | - | - | - | - | - | -  |
|  (+)-Chlorpheniramine | - | - | - | - | - | -  |
|  (+/-) Chlorpheniramine | - | - | - | - | - | -  |
|  Creatine | - | - | - | - | - | -  |
|  Dexbrompheniramine | - | - | - | - | - | -  |
|  4-Dimethylaminoantipyrine | - | - | - | - | - | -  |
|  Diphenhydramine | - | - | - | - | - | -  |
|  Dopamine | - | - | - | - | - | -  |
|  (+/-)-Ephedrine | - | - | - | - | - | -  |
|  Erythromycin | - | - | - | - | - | -  |
|  Ethanol | - | - | - | - | - | -  |
|  Furosemide | - | - | - | - | - | -  |
|  Glucose | - | - | - | - | - | -  |
|  Guaiacol Glyceryl Ether | - | - | - | - | - | -  |
|  Hemoglobin | - | - | - | - | - | -  |
|  Ibuprofen | - | - | - | - | - | -  |
|  Imipramine | - | - | - | - | - | -  |
|  (+/-)-Isoproterenol | - | - | - | - | - | -  |
|  Ketamine | - | - | - | - | - | -  |
|  Levorphanol | - | - | - | - | - | -  |
|  Lidocaine | - | - | - | - | - | -  |
|  Maprotiline | - | - | - | - | - | -  |
|  (1R,2S)-(-)-N-Methyl-Ephedrine | - | - | - | - | - | -  |
|  (+)-Norephedrine | - | - | - | - | - | -  |
|  Oxalic Acid | - | - | - | - | - | -  |
|  Penicillin- G | - | - | - | - | - | -  |
|  Pheniramine | - | - | - | - | - | -  |
|  Phenothiazine | - | - | - | - | - | -  |
|  1-Phenylephrine | - | - | - | - | - | -  |
|  ☐ Phenylethylamine | - | - | - | - | - | -  |
|  Procaine | - | - | - | - | - | -  |
|  Quinidine | - | - | - | - | - | -  |
|  Rantidine | - | - | - | - | - | -  |
|  Riboflavin | - | - | - | - | - | -  |

{13}

|  Sodium Chloride | - | - | - | - | - | -  |
| --- | --- | --- | --- | --- | --- | --- |
|  Sulindac | - | - | - | - | - | -  |
|  Theophylline | - | - | - | - | - | -  |
|  Trimipramine | - | - | - | - | - | -  |
|  Tyramine | - | - | - | - | - | -  |

The results of the negative interference study are presented below.

|  Compound | BAR | BZO | MDMA | MET | MTD | OPI | OXY  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Control | + | + | + | + | + | + | +  |
|  Acetaminophen | + | + | + | + | + | + | +  |
|  Acetone | + | + | + | + | + | + | +  |
|  Albumin | + | + | + | + | + | + | +  |
|  Amitriptyline | + | + | + | + | + | + | +  |
|  Ampicillin | + | + | + | + | + | + | +  |
|  Ascorbic Acid | + | + | + | + | + | + | +  |
|  Aspartame | + | + | + | + | + | + | +  |
|  Aspirin | + | + | + | + | + | + | +  |
|  Atropine | + | + | + | + | + | + | +  |
|  Benzocaine | + | + | + | + | + | + | +  |
|  Bilirubin | + | + | + | + | + | + | +  |
|  Caffeine | + | + | + | + | + | + | +  |
|  Chloroquine | + | + | + | + | + | + | +  |
|  (+)-Chlorpheniramine | + | + | + | + | + | + | +  |
|  (+/-) Chlorpheniramine | + | + | + | + | + | + | +  |
|  Creatine | + | + | + | + | + | + | +  |
|  Dexbrompheniramine | + | + | + | + | + | + | +  |
|  4-Dimethylaminoantipyrine | + | + | + | + | + | + | +  |
|  Diphenhydramine | + | + | + | + | + | + | +  |
|  Dopamine | + | + | + | + | + | + | +  |
|  (+/-)-Ephedrine | + | + | + | + | + | + | +  |
|  Erythromycin | + | + | + | + | + | + | +  |
|  Ethanol | + | + | + | + | + | + | +  |
|  Furosemide | + | + | + | + | + | + | +  |
|  Glucose | + | + | + | + | + | + | +  |
|  Guaiacol Glyceryl Ether | + | + | + | + | + | + | +  |
|  Hemoglobin | + | + | + | + | + | + | +  |
|  Ibuprofen | + | + | + | + | + | + | +  |
|  Imipramine | + | + | + | + | + | + | +  |
|  (+/-)-Isoproterenol | + | + | + | + | + | + | +  |
|  Ketamine | + | + | + | + | + | + | +  |
|  Levorphanol | + | + | + | + | + | + | +  |
|  Lidocaine | + | + | + | + | + | + | +  |

{14}

|  Maprotiline | + | + | + | + | + | +  |
| --- | --- | --- | --- | --- | --- | --- |
|  (1R,2S)-(-)-N-Methyl-Ephedrine | + | + | + | + | + | +  |
|  (+)-Norephedrine | + | + | + | + | + | +  |
|  Oxalic Acid | + | + | + | + | + | +  |
|  Penicillin- G | + | + | + | + | + | +  |
|  Pheniramine | + | + | + | + | + | +  |
|  Phenothiazine | + | + | + | + | + | +  |
|  1-Phenylephrine | + | + | + | + | + | +  |
|  □Phenylethylamine | + | + | + | + | + | +  |
|  Procaine | + | + | + | + | + | +  |
|  Quinidine | + | + | + | + | + | +  |
|  Rantidine | + | + | + | + | + | +  |
|  Riboflavin | + | + | + | + | + | +  |
|  Sodium Chloride | + | + | + | + | + | +  |
|  Sulindac | + | + | + | + | + | +  |
|  Theophylline | + | + | + | + | + | +  |
|  Trimipramine | + | + | + | + | + | +  |
|  Tyramine | + | + | + | + | + | +  |

The compounds listed above, when tested at a final concentration of  $100\ \mathrm{g/mL}$ , did not alter the expected negative or positive results of the ImmuTest Multi-Drug Screen Panel II Device. Therefore, at  $100\ \mathrm{g/mL}$  concentration, all of these compounds listed will not interfere with the test results obtained by the ImmuTest Multi-Drug Screen Panel II Device.

# e.3 Urinary pH

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 HCl or NaOH. The  $\mathsf{pH}$  adjusted sample solutions were tested in triplicate with the ImmuTest Multi-Drug Screen Panel II. An unaltered sample was used as a control. The results are summarized in the table below:

|  Drug | Conc. (ng/mL) | Control pH 6.9 (+/-) | pH 4 (+/-) | pH 5 (+/-) | pH 6 (+/-) | pH 7 (+/-) | pH 8 (+/-) | pH 9 (+/-)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  BAR | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  BZO | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |

{15}

|  MDMA | 250 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  750 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  MET100 | 500 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  1500 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  MTD | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  OPI300 | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |

The urinary pH variations, when tested with urine samples from pH 4 to 9, did not affect the expected test results of the ImmuTest Multi-Drug Screen Panel II Device.

# e.4 Urinary Specific Gravity

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 Panel II. An unaltered sample was used as a control. The results are summarized in the table below:

{16}

|  Drug | Conc. (ng/mL) | Control SG 1.01 (+/-) | SG 1.003 (+/-) | SG 1.02 (+/-) | SG 1.03 (+/-) | SG 1.04 (+/-)  |
| --- | --- | --- | --- | --- | --- | --- |
|  BAR | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  BZO | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  MDMA | 250 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  750 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  MET100 | 500 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  1500 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  MTD | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  OPI300 | 150 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  450 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |
|  OXY | 50 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3  |
|   |  150 | 3/0 | 3/0 | 3/0 | 3/0 | 3/0  |

Specific gravity

Specific Gravity variations between 1.004 to 1.04, did not affect the accuracy of the test results obtained with the ImmuTest Multi0Drug Screen Panel II.

# f. Assay cut-off:

The Substance Abuse and Mental Health Services Administration (SAMHSA) has not recommended a cutoff concentration for barbiturates, benzodiazepines, 3,4-methylenedioxymethamphetamine, methadone and oxycodone. The cutoff for those drugs and for opiates were chosen based on the levels used by predicate devices. SAMHSA has recommended a cutoff concentration for methamphetamine and the ImmuTest Multi-Drug Screen Panel II followed that recommendation.

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:

The ImmuTest Mutli-Drug Screen Panel II device was compared to the GC/MS, Applied Biotech/ Forefront Instacheck Drug Screen

{17}

Page 18 of 20

Test-BAR/BZO/MDMA, Pharmatech Quickscreen
Methamphetamine, Methadone, Opiates, American Bio Medica
RapidOne Oxy devices and to GC/MS values. Studies were conducted and compiled into the 2 charts shown below.

Sample description: A total of 642 samples were obtained from 2 clinical testing laboratories. An additional 25 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. Sixty negative urine samples were collected from presumed non-user volunteers. Forty five of the sixty samples were analyzed and were tested by the ImmuTest Multi-Drug Screen Panel II and with one of the predicate devices listed above. The remaining 15 samples were analyzed and found negative on the GC/MS.

Sample selection: The study included an adequate number of samples that contained drugs near the cutoff concentration of the assay. Approximately 10% of the study samples are evenly distributed between plus and minus 50% of the claimed cutoff concentration.

Number of study sites: one
Type of study site(s): Manufacturer's facility
Operator description: Not specified.

Candidate Device Results vs. Predicate Device Results

|   |  |  | Predicate Devices |   | % Agreement with Predicate Devices  |
| --- | --- | --- | --- | --- | --- |
|  Test |  |  | Positive | Negative |   |
|  BAR | ImmuTest | Positive | 87 | 1 | 97.5  |
|   |   |  Negative | 2 | 68 | 98.6  |
|  BZO | ImmuTest | Positive | 50 | 2 | 96.2  |
|   |   |  Negative | 2 | 79 | 97.5  |
|  MDMA | ImmuTest | Positive | 42 | 2 | 100  |
|   |   |  Negative | 0 | 75 | 97.4  |
|  MET1000 | ImmuTest | Positive | 65 | 0 | 97.0  |
|   |   |  Negative | 2 | 70 | 100  |
|  MTD | ImmuTest | Positive | 69 | 2 | 100  |
|   |   |  Negative | 0 | 66 | 97.1  |
|  OPI300 | ImmuTest | Positive | 82 | 3 | 100  |
|   |   |  Negative | 0 | 67 | 95.7  |
|  OXY | ImmuTest | Positive | 54 | 2 | 97.0  |

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Page 19 of 20

|   |  | Negative | 0 | 65 | 100  |
| --- | --- | --- | --- | --- | --- |

Candidate Device Results vs. stratified GC/MS Values

|  ImmuTest Multi-Drug Screen Panel II | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | Percent Agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- |
|  BAR | <150 ng/mL | 228-284 ng/mL | 338-449 ng/mL | 525-29,920 ng/mL | % Agreement  |
|  Positive | 0 | 1 | 4 | 83 | 96.7  |
|  Negative | 15 | 7 | 3 | 0 | 95.7  |
|  BZO | <150 ng/mL | 151-299 ng/mL | 317-445 ng/mL | 452-20,620 ng/mL | % Agreement  |
|  Positive | 0 | 3 | 12 | 37 | 98.0  |
|  Negative | 18 | 17 | 1 | 0 | 92.1  |
|  MDMA | <250 ng/mL | 257-397 ng/mL | 522-759 ng/mL | 1220-7,500 ng/mL | % Agreement  |
|  Positive | 0 | 1 | 6 | 37 | 100  |
|  Negative | 24 | 6 | 0 | 0 | 96.8  |
|  MET1000 | <500 ng/mL | 519-912 ng/mL | 1,017-1,473 ng/mL | 1,587-291,000 ng/mL | % Agreement  |
|  Positive | 0 | 1 | 6 | 58 | 100  |
|  Negative | 20 | 7 | 0 | 0 | 96.4  |
|  MTD | <150 ng/mL | 150-275 ng/mL | 303-422 ng/mL | 506-71,800 ng/mL | % Agreement  |
|  Positive | 0 | 0 | 6 | 65 | 98.6  |
|  Negative | 15 | 5 | 1 | 0 | 100  |
|  OPI300 | <150 ng/mL | 150-280 ng/mL | 337-450 ng/mL | 502-230,140 ng/mL | % Agreement  |
|  Positive | 0 | 1 | 6 | 78 | 100  |
|  Negative | 16 | 6 | 0 | 0 | 95.7  |
|  OXY | <50 ng/mL | 50-98 ng/mL | 118-148 ng/mL | 201-9,455 ng/mL | % Agreement  |
|  Positive | 0 | 1 | 6 | 47 | 100  |
|  Negative | 15 | 7 | 0 | 0 | 95.7  |

GC/MS values used to categorize samples in this table are based on the sum of the concentrations of:
Barbiturates: Pentobarbital, Phenobarbital and Secobarbital.
Benzodiazepines: Alpabenzodiazepine, Oxabenzodiazepine and Temabenzodiazepines.
MDMA: N/A
Methamphetamine: N/A

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Page 20 of 20

Methadone: N/A
Opiates: Morphine and Codeine
Oxycodone: N/A

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

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

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K042975](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K042975)

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