← Product Code [DKZ](/productcode/DKZ) · K041685

# ACON MULTI-CLIN DRUG SCREEN TEST DEVICE (K041685)

_ACON Laboratories, Inc. · DKZ · Aug 30, 2004 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K041685

## Device Facts

- **Applicant:** ACON Laboratories, Inc.
- **Product Code:** [DKZ](/productcode/DKZ.md)
- **Decision Date:** Aug 30, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

This device is used in the diagnosis and treatment of drug use or overdose. The ACON multi-CLIN Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants in urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine 1000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Cocaine 300 ng/mL, Marijuana 50 ng/mL, Methylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Proxyphene 300 ng/mL and Tricyclic Antidepressants 1000 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive test results are used.

## Device Story

Single-use, visually-read cassette device; contains four immunochromatographic strips for simultaneous detection of 11 drugs in urine. Input: urine sample added via dispenser. Principle: competitive binding lateral flow immunoassay; drug-specific antibodies on particles bind to immobilized drug-conjugate on membrane. Output: visual colored lines; absence of test line indicates drug presence above cutoff; presence of control line indicates valid test. Used in clinical/point-of-care settings by healthcare professionals. Provides preliminary analytical results; requires GC/MS confirmation for clinical decision-making regarding drug use or overdose.

## Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing, including precision/reproducibility, cross-reactivity, and interference studies. Method comparison performed against predicate devices and GC/MS reference method using clinical urine samples. Overall agreement with GC/MS ranged from 94% to 99% across analytes.

## Technological Characteristics

Lateral flow immunochromatographic cassette; competitive binding principle. Plastic housing with four test strips. Visually read; no instrumentation required. Qualitative detection based on SAMHSA-recommended cut-off concentrations. Internal procedural controls (negative/positive) included on each strip.

## Regulatory Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

## Special Controls

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

- ACON One-Step Multi-drug Multi-line Screen Test (k020313)
- ACON One-Step Multi-drug Multi-line Screen Test (k023946)
- ACON OXY One-Step Oxycodone Test Device (k033047)
- ACON One-Step Propoxyphene Test Device (k040445)

## Submission Summary (Full Text)

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

A. 510(k) Number:
k041685

B. Purpose for Submission:
New product

C. Analyte:
Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana,
Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine,
Propoxyphene, and Tricyclic Antidepressants

D. Type of Test:
Qualitative lateral flow immunochromatographic test

E. Applicant:
ACON Laboratories, Inc.

F. Proprietary and Established Names:
ACON multi-CLIN Drug Screen Test Device

G. Regulatory Information:

1. Regulation section:
21 CFR §862.3100: Test System, Amphetamine
21 CFR §862.3150: Test System, Barbiturate
21 CFR §862.3170: Enzyme Immunoassay, Benzodiazepine
21 CFR §862.3250: Enzyme Immunoassay, Cocaine and Cocaine Metabolites
21 CFR §862.3870: Enzyme Immunoassay, Cannabinoids
21 CFR §862.3610: Test System, Methamphetamine
21 CFR §862.3650: Enzyme Immunoassay, Opiates (Oxycodone)
Unclassified : Enzyme Immunoassay, Phencyclidine
21 CFR §862.3700: Enzyme Immunoassay, Propoxyphene
21 CFR §862.3910: Tricyclic Antidepressant Drugs Test System

2. Classification:
Class II

3. Product Code:
DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG

4. Panel:
Toxicology (91)

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## H. Intended Use:

1. **Intended use(s):**
This device is used in the diagnosis and treatment of drug use or overdose.

2. **Indication(s) for use:**
The ACON multi-CLIN Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants in urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine 1000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Cocaine 300 ng/mL, Marijuana 50 ng/mL, Methylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Proxyphene 300 ng/mL and Tricyclic Antidepressants 1000 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive test results are used.

3. **Special condition for use statement(s):**
The ACON multi-CLIN Drug Screen Test provides only a preliminary analytical test result. A more specific alternative chemical method, such as GC/MS, must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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

## I. Device Description:

The device is a single-use visually read cassette device. It has a plastic housing that contains the test strip. A plastic sample dispenser is also provided. Several drops of urine are added to start the test which employs traditional immunochromatographic technology. Three to four drug tests and controls appear on each of four strips in the cassette.

## J. Substantial Equivalence Information:

1. **Predicate device name(s):**

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ACON One-Step Multi-drug Multi-line Screen Test: Amphetamines, Cocaine, Methamphetamine, Opiates, Marijuana, and PCP

ACON One-Step Multi-drug Multi-line Screen Test: Barbiturates, Benzodiazepines, Methadone, MDMA, Opiates, and Tricyclic Antidepressants

ACON OXY One-Step Oxycodone Test Device

ACON One-Step Propoxyphene Test Device

2. Predicate K number(s):

3. k020313, k023946, k033047, k040445 Comparison with predicate:

The device is similar to or the same as to the previously cleared predicate(s) in the following ways: manufacturer, test principles, indication for use, cut-off concentration(s), used in a professional and point-of-care setting, sample matrix, endpoint, and test time.

The essential difference between the device and the predicate(s) is the test format; the new test contains 11 drug assays on four immunochromatographic strips while the predicate(s) were individual tests on each strip or cartridge.

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

The sponsor did not reference any standards in the 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 antibody-coated particles in the device. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the test line region. A red line will not form if the sample contains drug in excess of the cutoff level because the drug will saturate all the binding sites of the drug-specific antibody. Each strip in the device contains both a negative and a positive procedural control. Formation of a red line in the negative control line region indicates that the proper volume of urine has been added and membrane wicking has occurred. The continued presence of a blue line in the positive control region could indicate that the immunochemical reaction did not occur. If either control does not work the test is invalid and should be repeated.

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

1. Analytical performance:

a. Precision/Reproducibility:

See section 1.d below.

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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

This device has internal process controls. A red line appearing in the negative control region confirms sufficient sample volume, adequate

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membrane wicking, and that the correct technique has been used. Users are informed not to interpret the test if a line forms in the positive control region or if no line forms in the negative control region.

Control standards are not supplied with this device; however it is good laboratory practice to confirm the test procedure and to verify proper test performance. Users should follow all applicable guidelines for testing QC materials.

d. Detection limit:

The sponsor tested the device to determine if its analytical specificity was at or around the same designated cut-off concentrations as those of the individual predicate strips. These cutoffs are based on the recommendation of the Substance Abuse and Mental Health Services Administration (SAMHSA). Drug free urine and drug urine samples at -65% cut-off, -50% cutoff, -25% cut-off, +25% cut-off, and +50% cutoff were tested with three lots of ACON multi-CLIN Drug Screen Test Device as well as three lots of ACON Single Drug Test Strips according to package inserts. Each lot was tested thirty times. The average percent correct read is described in the table below:

Cut-Off Concentration Testing: Average Correct Result

|  Drug Tested | Drug-free Urine | -65% Cut-Off | -50% Cut-Off | -25% Cut-Off | +25% Cut-Off | +50% Cut-Off  |
| --- | --- | --- | --- | --- | --- | --- |
|  Amphetamines | 100% | 100% | 100% | 72.2 | 91.1 | 100%  |
|  Barbiturates | 100% | 100% | 100% | 67.8 | 94.4 | 100%  |
|  Benzodiazepines | 100% | 100% | 100% | 70.0 | 91.1 | 100%  |
|  Cocaine/Metabolites | 100% | 100% | 100% | 72.2 | 92.2 | 100%  |
|  Marijuana (THC) | 100% | 100% | 100% | 74.4 | 83.3 | 100%  |
|  MDMA | 100% | 100% | 100% | 67.8 | 91.1 | 100%  |
|  Opiates | 100% | 100% | 100% | 67.8 | 92.2 | 100%  |
|  Oxycodone | 100% | 100% | 100% | 70.0 | 88.9 | 100%  |
|  Phencyclidine | 100% | 100% | 100% | 66.7 | 93.3 | 100%  |
|  Propoxyphene | 100% | 100% | 100% | 68.9 | 91.1 | 100%  |
|  Tricyclic Antidepressants | 100% | 100% | 100% | 75.6 | 94.4 | 100%  |

e. Analytical specificity:

The drugs tested for by this device, their known metabolites, and related compounds were spiked into drug-free urine at a concentration of 1000 ng/mL, then serially diluted and tested with the ACON multi-CLIN Drug Screen Test Device until the

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concentrations which yielded a negative result were obtained. The following table lists the lowest concentration which yields a positive result for the compound being tested when read at five minutes. Cross-reactivity was calculated by dividing the concentration at which the compound yielded a positive result by the designated cut-off concentration.

ACON multi-CLIN Drug Test: Cross-reactivity of Compounds

|  Compound | Conc (ng/mL) | % Cross Reactivity | Compound | Conc (ng/mL) | % Cross Reactivity  |
| --- | --- | --- | --- | --- | --- |
|  AMPHETAMINES |   |   | METHYLENEDIOXYMETHAMPHETAMINE (MDMA)  |   |   |
|  d-Amphetamine | 1,000 | 100 | 3,4-MDMA | 500 | 100  |
|  d,l-Amphetamine | 3000 | 33 | l-Methamphetamine | 100,000 | 0.5  |
|  l-Amphetamine | 50,000 | 2 | 3,4-MDA | 3000 | 17  |
|  p-OH-Amphetamine | 3125 | 32 | 3,4-MDMA | 300 | 167  |
|  3,4-MDA | 2000 | 50 | OPIATES  |   |   |
|  Phentermine | 3000 | 33 | Morphine | 300 | 100  |
|  BARBITURATES |   |   | Codeine | 300 | 100  |
|  Secobarbital | 300 | 100 | Ethylmorphine | 6250 | 5  |
|  Amobarbital | 300 | 100 | Hydrocodone | 50,000 | 0.6  |
|  Alphenal | 150 | 200 | Hydromorphone | 3125 | 10  |
|  Aprobarbital | 200 | 150 | Levorphanol | 1500 | 20  |
|  Butabarbital | 75 | 400 | 6-Monoacetylmorphine | 400 | 75  |
|  Butalbital | 2500 | 12 | Morphine-3-β-d-glucuronide | 1000 | 30  |
|  Butethanol | 100 | 300 | Norcodeine | 6250 | 5  |
|  Cyclobarbital | 400 | 75 | Normorphone | 100,000 | 0.3  |
|  Cyclopentobarbital | 600 | 50 | Oxycodone | 30,000 | 1  |
|  Pentobarbital | 300 | 100 | Oxymorphone | 100,000 | 0.3  |
|  Phenobarbital | 100 | 300 | Thebaine | 6250 | 5  |
|  BENZODIAZEPINES |   |   | OXYCODONE  |   |   |
|  Oxazepam | 300 | 100 | Oxycodone | 100 | 100  |
|  Alprazolam | 196 | 153 | 6-Acetylcodeine | 100,000 | 0.1  |
|  Alprazolam, -OH | 1262 | 24 | Codeine | 25,000 | 0.4  |
|  Bromazepam | 1562 | 19 | Dihydrocodeine | 12,500 | 0.8  |
|  Chlordiazepoxide | 1562 | 19 | Ethylmorphine | 25,000 | 0.4  |
|  Clobazam | 98 | 306 | Hydrocodone | 6250 | 2  |
|  Clonazepam | 781 | 38 | Hydromorphone | 12,500 | 0.8  |
|  Chlorazepate | 195 | 154 | Levorphanol | 100,000 | 0.1  |
|  Delorazepam | 1562 | 19 | 6-Monoacetylmorphine | 100,000 | 0.1  |
|  Desalkylflurazepam | 390 | 77 | Morphine | 100,000 | 0.1  |
|  Diazepam | 195 | 154 | Morphine-3-β-d-glucuronide | 100,000 | 0.1  |
|  Estazolam | 2500 | 12 | Norcodeine | 100,000 | 0.1  |
|  Flunitrazepam | 390 | 77 | Normorphone | 100,000 | 0.1  |
|  (±) Lorazepam | 1562 | 19 | Oxymorphone | 780 | 13  |
|  RS-Lorazepam glucuronide | 156 | 192 | Procaine | 100,000 | 0.1  |
|  Midazolam | 12,500 | 2 | Thebaine | 25,000 | 0.4  |
|  Nitrazepam | 98 | 306 | PHENCYCLIDINE  |   |   |
|  Norchlordiazepoxide | 195 | 154 | Phencyclidine | 25 | 100  |

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|  Compound | Conc (ng/mL) | % Cross Reactivity | Compound | Conc (ng/mL) | % Cross Reactivity  |
| --- | --- | --- | --- | --- | --- |
|  Nordiazepam | 390 | 77 | 4-Hydroxyphenyclidine | 12,500 | 0.2  |
|  Temazepam | 98 | 306 | PROPOXYPHENE |  |   |
|  Triazolam | 2500 | 12 | d-Propoxyphene | 300 | 100  |
|  **COCAINE** |   |   | Norpropoxyphene | 300 | 100  |
|  Benzoylecgonine | 300 | 100 | **TRICYCLIC ANTIDEPRESSANTS**  |   |   |
|  Cocaine | 780 | 38 | Nortriptyline | 1000 | 100  |
|  Cocaethylene | 12,500 | 2 | Amitriptyline | 1500 | 67  |
|  Ecgonine | 32,000 | 0.9 | Clomipramine | 12,500 | 8  |
|  **MARIJUANA** |   |   | Cyclobenzaprine | 6250 | 16  |
|  11-nor-Δ⁹-THC-9-COOH | 50 | 100 | Desipramine | 200 | 500  |
|  Cannabinol | 20,000 | 0.25 | Imipramine | 400 | 250  |
|  Δ⁹-THC | 15,000 | 0.33 | Maprotiline | 2000 | 50  |
|  -Δ⁹-THC | 15,000 | 0.33 | Nordoxepine | 1000 | 100  |
|   |  |  | Perphenazine | 50,000 | 2  |
|   |  |  | Promazine | 1500 | 67  |
|   |  |  | Promethazine | 25,000 | 4  |
|   |  |  | Trimipramine maleate | 3000 | 33  |

Almost 200 compounds were tested for possible interference with the ACON multi-CLIN Drug Screen Test in drug-free urine, in a urine pool spiked with -65% of the cutoff levels of the drugs of abuse, and in a urine pool spiked with +50% of the cutoff levels of the drugs of abuse. The compounds tested for possible interference are listed in the package insert; no compound caused an incorrect test result in any of the three urine pools when tested at 1000 ng/mL.

The pH of an aliquoted negative urine pool was adjusted to a range of 5 to 9 in 1 pH unit increments; four of the five aliquots were spiked with a drug to -65%, -50%, +25%, and +50% of the cutoff concentration. The spiked, pH-adjusted urine was tested in duplicate. Altering the pH of the urine sample did not affect the accuracy of any of the test results.

Fifteen (15) urine samples of specific gravity ranging from 1.004 to 1.034 were aliquoted into five samples each; one sample remained neat while the other four aliquots were spiked with each drug to the concentration of -65%, -50%, +25%, and +50% of the cutoff respectively. Each sample was tested in duplicate. Variations in specific gravity did not affect the accuracy of any of the test results

f. Assay cut-off:
The identified cutoff concentrations are those recommended by the Substance Abuse and Mental Health Services Administration (SAMHSA); these cutoffs are listed above. The test will yield a

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positive result when a given drug exceeds this concentration in the urine sample. Analytical performance of the device around the cutoff is described in Section 1.M.d above.

## 2. Comparison studies:

### a. Method comparison with predicate device:

Urine samples were collected from presumed non-user volunteers and known positive specimens were obtained from several clinical laboratories. Drug positive samples were confirmed by GC/MS or HPLC. The percentage of samples $\pm 25\%$ of the cutoff (as determined by GC/MS) varied by drug: AMP $7.6\%$, BAR $2.9\%$, BZO $2.6\%$, COC $7.7\%$, THC $5.1\%$, MDMA $2.8\%$, OPI $3.8\%$, OXY $2\%$, PCP $3.1\%$, PPX $1.6\%$, TCA $6.2\%$. Specimens were coded, randomized, and blinded for side-by-side comparisons between ACON multi-CLIN Drug Screen Test and ACON Single Drug Test Strips. The results are shown in the tables below:

Comparison of ACON multi-CLIN to ACON One Step Tests

|   | ACON Single Test  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  AMP |   | BAR |   | BZO |   | COC  |   |
|   |   |  pos | neg | pos | neg | pos | neg | pos | neg  |
|  ACON multi-CLIN | Positive | 140 | 0 | 103 | 0 | 122 | 1 | 132 | 4  |
|   |  Negative | 3 | 307 | 0 | 307 | 0 | 302 | 0 | 308  |
|   | Total | 143 | 307 | 103 | 307 | 122 | 303 | 132 | 312  |
|  % Agreement with ACON Single Test |   | 98 | 100 | 100 | 100 | 100 | 99.7 | 100 | 98.7  |
|  % Overall Agreement |   | 99 |   | 100 |   | 99 |   | 99  |   |
|   | ACON Single Test  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  THC |   | MDMA |   | OPI |   | OXY  |   |
|   |   |  pos | neg | pos | neg | pos | neg | pos | neg  |
|  ACON multi-CLIN | Positive | 132 | 0 | 91 | 1 | 149 | 0 | 141 | 2  |
|   |  Negative | 9 | 307 | 0 | 301 | 0 | 300 | 0 | 307  |
|   | Total | 141 | 307 | 91 | 302 | 149 | 300 | 141 | 309  |
|  % Agreement with ACON Single Test |   | 94 | 100 | 100 | 99.7 | 100 | 100 | 100 | 99.4  |
|  % Overall Agreement |   | 98 |   | 99 |   | 100 |   | 99  |   |
|   | ACON Single Test  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  PCP |   | PPX |   | TCA  |   |
|   |   |  pos | neg | pos | neg | pos | neg  |
|  ACON multi-CLIN | Positive | 89 | 0 | 135 | 0 | 54 | 0  |
|   |  Negative | 0 | 301 | 0 | 305 | 0 | 316  |

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|   | Total | 89 | 301 | 135 | 305 | 54 | 316  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  % Agreement with ACON Single Test |   | 100 | 100 | 100 | 100 | 100 | 100  |
|  % Overall Agreement |   | 100 |   | 100 |   | 100  |   |

Samples were analyzed by GC/MS and compared to the ACON multi-CLIN test. Samples were considered positive if they were above the cutoff level listed in Section H.2. Results are described in the tables below:

## Comparison of ACON multi-CLIN to GC/MS

|   | GC/MS  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  AMP |   | BAR |   | BZO |   | COC  |   |
|   |   |  pos | neg | pos | neg | pos | neg | pos | neg  |
|  ACON multi-CLIN | Positive | 134 | 6 | 99 | 4 | 139 | 2 | 119 | 17  |
|   |  Negative | 2 | 308 | 2 | 305 | 1 | 308 | 0 | 308  |
|   | Total | 136 | 314 | 101 | 309 | 140 | 310 | 119 | 325  |
|  % Agreement with GC/MS |   | 98.5 | 98.1 | 98 | 99 | 99.3 | 99.4 | 100 | 95  |
|  % Overall Agreement |   | 98 |   | 99 |   | 99 |   | 96  |   |
|   | GC/MS  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  THC |   | MDMA |   | OPI |   | OXY  |   |
|   |   |  pos | neg | pos | neg | pos | neg | pos | neg  |
|  ACON multi-CLIN | Positive | 116 | 16 | 88 | 4 | 140 | 9 | 140 | 3  |
|   |  Negative | 5 | 311 | 0 | 301 | 0 | 300 | 1 | 306  |
|   | Total | 121 | 327 | 88 | 305 | 140 | 309 | 141 | 309  |
|  % Agreement with GC/MS |   | 95.9 | 95.1 | 100 | 98.7 | 100 | 97.1 | 99.3 | 99  |
|  % Overall Agreement |   | 95 |   | 99 |   | 98 |   | 99  |   |
|   | GC/MS  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  PCP |   | PPX |   | TCA  |   |
|   |   |  pos | neg | pos | neg | pos | neg  |
|  ACON multi-CLIN | Positive | 85 | 4 | 145 | 0 | 32 | 22  |
|   |  Negative | 1 | 300 | 1 | 304 | 0 | 316  |
|   | Total | 86 | 304 | 146 | 304 | 32 | 338  |
|  % Agreement with GC?MS |   | 98.8 | 98.7 | 99.3 | 100 | 100 | 93.5  |
|  % Overall Agreement |   | 99 |   | 99 |   | 94  |   |

## b. Matrix comparison:

Not applicable; this device is only for use with urine samples

## 3. Clinical studies:

### a. Clinical sensitivity:

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

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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):
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-staging.innolitics.com/device/K041685](https://fda-staging.innolitics.com/device/K041685)

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