← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K152590

# ACCU NEWS Drug Screening Test Card/Urine Cup (K152590)

_Coretests, Inc. · DKZ · Apr 15, 2016 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K152590

## Device Facts

- **Applicant:** Coretests, Inc.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** Apr 15, 2016
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The ACCU NEWS Drug Screening Test Card and Urine Cup are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine and Morphine in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Amphetamine AMP d-Amphetamine 1000 Cocaine COC Benzoylecgonine 300 Methamphetamine MET d-Methamphetamine 1000 Morphine MOP Morphine 300 Marijuana THC 11-Nor-Δ9-THC-9-COOH 50 The ACCU NEWS Drug Screening Test Card and Urine Cup provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing, the second step in the process, is provided in the package labeling.

## Device Story

Rapid lateral flow immunoassay for qualitative drug screening in human urine; available as test card or integrated urine cup. Principle: competitive binding between drug-protein conjugates on membrane and drug/metabolites in urine sample; anti-drug antibody-colloidal gold conjugates used for visualization. Negative result: visible line in test region; positive result: absence of line. Control line confirms proper test performance. Used by consumers (OTC) or professionals; provides preliminary results only. Requires confirmatory testing via chromatography/mass spectrometry for positive results. Benefits: provides immediate information regarding presence of drugs/metabolites to facilitate further clinical or personal decision-making.

## Clinical Evidence

Bench testing only. Performance evaluated via method comparison against GC/MS using 340 clinical samples, showing >96% agreement. Lay-user study (n=300, ages 18-47) demonstrated >95% agreement with GC/MS results. Interference testing confirmed no cross-reactivity with common substances, pH (3.0-9.0), or specific gravity (1.001-1.040).

## Technological Characteristics

Lateral flow immunoassay; nitrocellulose membrane; colloidal gold-labeled mouse monoclonal antibody; goat anti-mouse polyclonal antibody control. Single-use test card or integrated urine cup. Storage: 2-30°C. Qualitative visual readout.

## 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

- Innovacon® Spectrum II Test Card/Test Card with Integrated Cups ([K061718](/device/K061718.md))

## 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 MEMORANDUM ASSAY ONLY TEMPLATE

A. 510(k) Number:
k152590

B. Purpose for Submission:
New device

C. Measurand:
Amphetamine, Methamphetamine, Morphine, Cocaine, Marijuana

D. Type of Test:
Qualitative immunoassay

E. Applicant:
Coretests, Inc.

F. Proprietary and Established Names:
ACCU NEWS Drug Screening Test Card
ACCU NEWS Drug Screening Urine Cup

G. Regulatory Information:
|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LDJ | II | 862.3870, Cannabinoid Test System | 91-Toxicology  |
|  DIO | II | 862.3250, Cocaine and Cocaine Metabolite Test System | 91-Toxicology  |
|  DNK | II | 862.3640, Morphine Test System | 91-Toxicology  |
|  LAF | II | 862.3610, Methamphetamine Test System | 91-Toxicology  |
|  DKZ | II | 862.3100, Amphetamine Test System | 91-Toxicology  |

{1}

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The ACCU NEWS Drug Screening Test Card and Urine Cup are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine and Morphine in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

|  Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL)  |
| --- | --- | --- | --- |
|  Amphetamine | AMP | d-Amphetamine | 1000  |
|  Cocaine | COC | Benzoylecgonine | 300  |
|  Methamphetamine | MET | d-Methamphetamine | 1000  |
|  Morphine | MOP | Morphine | 300  |
|  Marijuana | THC | 11-Nor-Δ9-THC-9-COOH | 50  |

The ACCU NEWS Drug Screening Test Card and Urine Cup provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing, the second step in the process, is provided in the package labeling.

3. Special conditions for use statement(s):

For prescription and over-the-counter (OTC) use.

4. Special instrument requirements:

Not applicable, these are visually-read single-use devices.

I. Device Description:

These devices are for use with human urine only. The device is available in two different formats, 1) test card and 2) urine cup. They consist of:

{2}

1. One pouch containing the test device and desiccant (the desiccant is for storage purpose only)
2. A sample collection cup, a plastic specimen bag, a confirmation test label, and a pre-addressed mailer (for confirmation test)
3. An instruction sheet

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Innovacon Spectrum II Test Card/Test Card with Integrated Cups.

2. Predicate 510(k) number(s):

K061718

3. Comparison with predicate:

|  Similarities and Differences  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Item | Predicate Device: Innovacon Spectrum II Test Card/Test Card with Integrated Cups (k061718) |   | Candidate Device: ACCU NEWS Drug Screening Test Card/Urine Cup (k152590)  |   |
|  Intended use | For detection of drugs/drug metabolites in human urine to screen for drugs of abuse. |   | Same  |   |
|  Specimen | Human urine |   | Same  |   |
|  Results | Qualitative |   | Same  |   |
|  Methodology | Competitive Lateral Flow Immunoassay |   | Same  |   |
|  Intended Users | Prescription users |   | Prescription and over-the-counter (OTC) users  |   |
|  Formats | Test Card and Urine Cup |   | Same  |   |
|  Storage Temperature | 2-30°C (36-86°F) |   | Same  |   |
|  Analytes and Cutoff (ng/ml) | Amphetamine | 1000/300 | Amphetamine | 1000  |
|   |  Cocaine | 300/150 | Cocaine | 300  |
|   |  Methamphetamine | 1000/500 | Methamphetamine | 1000  |
|   |  Morphine | 2000/300 | Morphine | 300  |
|   |  Marijuana | 50 | Marijuana | 50  |

{3}

4

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

CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition

L. Test Principle:

The ACCU NEWS Drug Screening Test Card and ACCU NEWS Urine Cup test devices are rapid lateral flow immunoassays in which drug-protein conjugates in the device compete with drugs or drug metabolites that may be present in urine. On each test strip, a drug-protein conjugate is present in the test band of the membrane (known as the test region, T), and the anti-drug antibody-colloidal gold conjugate pads are at the forward end of the membrane. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible line in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite competes with drug-protein conjugates on the test and region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored drug antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The precision performance of the test strips of the devices was evaluated using 3 lots of testing devices conducted by 3 operators. Urine samples were spiked with different drug concentrations: negative, -50%, -25%, cut-off, +25%, and +50% of cutoff concentrations. The drug concentrations in the urine sample were confirmed by GC/MS analysis. Samples were blind-labeled and randomly distributed among operators. The study was conducted over 4 to 10 days. The results are summarized below: Results for Test Card:

|  Target Drug | Concentration Tested | Total of three operators  |
| --- | --- | --- |
|   |   |  Neg/Pos  |
|  AMP (cutoff: 1000 ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 6/24  |
|   |  +25% of cutoff | 0/30  |
|   |  +50% of cutoff | 0/30  |
|  MET | Negative | 30/0  |

{4}

5

|  Target Drug | Concentration Tested | Total of three operators  |
| --- | --- | --- |
|   |   |  Neg/Pos  |
|  (cutoff: 1000ng/ml) | -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 10/20  |
|   |  +25% of cutoff | 0/30  |
|   |  +50% of cutoff | 0/30  |
|  MOP
(cutoff: 300ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 7/23  |
|   |  +25% of cutoff | 0/30  |
|   |  +50% of cutoff | 0/30  |
|  COC
(cutoff: 300ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 29/1  |
|   |  Cutoff | 21/9  |
|   |  +25% of cutoff | 1/29  |
|   |  +50% of cutoff | 0/30  |
|  THC
(cutoff: 50ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 24/6  |
|   |  +25% of cutoff | 0/30  |
|   |  +50% of cutoff | 0/30  |

Results for Urine Cup:

|  Target Drug | Concentration Tested | Total of three operators  |
| --- | --- | --- |
|   |   |  Neg/Pos  |
|  AMP
(cutoff: 1000 ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 16/14  |
|   |  +25% of cutoff | 0/30  |
|   |  +50% of cutoff | 0/30  |
|  MET
(cutoff: 1000ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 14/16  |

{5}

|  Target Drug | Concentration Tested | Total of three operators  |
| --- | --- | --- |
|   |   | Neg/Pos  |
|   | +25% of cutoff | 1/29  |
|   |  +50% of cutoff | 0/30  |
|  MOP (cutoff: 300ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 17/13  |
|   |  +25% of cutoff | 2/28  |
|   |  +50% of cutoff | 0/30  |
|  COC (cutoff: 300ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 19/11  |
|   |  +25% of cutoff | 2/28  |
|   |  +50% of cutoff | 0/30  |
|  THC (cutoff: 50ng/ml) | Negative | 30/0  |
|   |  -50% of cutoff | 30/0  |
|   |  -25% of cutoff | 30/0  |
|   |  Cutoff | 23/7  |
|   |  +25% of cutoff | 0/30  |
|   |  +50% of cutoff | 0/30  |

b. Linearity/assay reportable range:

Not applicable. These devices are intended for qualitative use only.

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

Stability: Device stability has been evaluated through accelerated studies. Protocols and acceptance criteria were reviewed and found to be acceptable to support the claims that the devices are stable for two years (24 months) when stored at 36-86°F (2-30° C).

Real-time stability protocols and acceptance criteria were reviewed and found to be acceptable. The real-time stability studies are ongoing.

d. Detection limit:

See Precision/Reproducibility section in M.1.a above.

e. Analytical specificity:

For each drug, specificity was evaluated by spiking various concentrations of structurally similar compounds into drug-free urine. Results are expressed as a

{6}

minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross-reactivity of those compounds is listed below:

| Drug Test | Compound | Concentration Equivalent to the Cutoff (ng/mL) | Cross-Reactivity (%) |
| --- | --- | --- | --- |
| AMP | d-Amphetamine | 1000 | 100 |
| d,l-Amphetamine | 3,000 | 33.3 |
| l-Amphetamine | 50,000 | 2 |
| d-Methamphetamine | >100,000 | <1 |
| l-Methamphetamine | >100,000 | <1 |
| d-Ephedrine | >100,000 | <1 |
| l-Ephedrine | >100,000 | <1 |
| d-Pseudoephedrine | >100,000 | <1 |
| l-Pseudoephedrine | >100,000 | <1 |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | 2500 | 40 |
| 3,4-Methylenedioxythylamphetamine (MDEA) | >100,000 | <1 |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | >100,000 | <1 |
| Phentermine | 25000 | 4 |
| MET | d-Methamphetamine | 1000 | 100 |
| l-Methamphetamine | 100,000 | 1 |
| d-Amphetamine | >100,000 | <1 |
| l-Amphetamine | >100,000 | <1 |
| d-Ephedrine | >100,000 | <1 |
| l-Ephedrine | >100,000 | <1 |
| d-Pseudoephedrine | >100,000 | <1 |
| l-Pseudoephedrine | >100,000 | <1 |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | >100,000 | <1 |
| 3,4-Methylenedioxythylamphetamine (MDEA) | 50,000 | 2 |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 25,000 | 4 |
| Chloroquine | 50,000 | 2 |
| β-Phenylethylamine | 50,000 | 2 |
| Trimethobenamide | 10,000 | 10 |

{7}

|  Drug Test | Compound | Concentration Equivalent to the Cutoff (ng/mL) | Cross-Reactivity (%)  |
| --- | --- | --- | --- |
|  MOP | Morphine | 300 | 100  |
|   |  Codeine | 300 | 100  |
|   |  Ethylmorphine | 300 | 100  |
|   |  Heroin | 300 | 100  |
|   |  6-Monoacetylmorphine | 300 | 100  |
|   |  Hydrocodone | 5,000 | 6  |
|   |  Hydromorphone | 5,000 | 6  |
|   |  Morphine-3-β-glucuronide | 1,000 | 30  |
|   |  Oxycodone | 100,000 | <1  |
|  COC | Benzoylecogonine | 300 | 100  |
|   |  Cocaine HCl | 750 | 40  |
|   |  Cocaethylene | 12,500 | 2.4  |
|   |  Ecgonine | 32,000 | <1  |
|   |  Norcocaine | 100,000 | <1  |
|  THC | 11-Nor-Δ9-Tetrahydrocannabinol carboxylic acid | 50 | 100  |
|   |  11-Hydroxy-Δ9-Tetrahydrocannabinol | 2,500 | 2  |
|   |  Δ8-Tetrahydrocannabinol | 7,500 | <1  |
|   |  Δ9-Tetrahydrocannabinol | 10,000 | <1  |
|   |  Cannabinol | 10,000 | <1  |
|   |  Cannabidiol | 100,000 | <1  |

The sponsor also evaluated whether various substances commonly found in human urine in physiological or pathological conditions would interfere with test results. The following compounds were spiked into drug positive or negative urine at a concentration of  $100\mathrm{ug / ml}$ ; no interference was detected.

|  Acetylsalicyclic Acid | Ethyl-p-aminobenzoate | Oxymetazoline  |
| --- | --- | --- |
|  Aminopyrine | Erythromycin | Papaverine  |
|  Amoxicillin | β-Estradiol | Penicillin-G  |
|  Ampicillin | Fenoprofen | Perphenazine  |
|  Apomorphine | Furosemide | Phenacetin  |
|  Aspartame | Gentisic acid | Phenelzine  |
|  Atropine | Hemoglobin | L-Phenylephrine  |
|  Benzilic acid | Hydralazine | β-Phenylethylamine  |
|  Benzoic acid | Hydrochlorothiazide | Phenylpropanolamine  |
|  Bilirubin | Hydrocortisone | Prednisone  |
|  Caffeine | 3-Hydroxytyramine | D,L-Propanolol  |
|  Chloral hydrate | D,L-Isoproterenol | D-Pseudoephedrine  |
|  Chloramphenicol | Isoxsuprine | Quinidine  |

{8}

9

|  Chlorothiazide | Ketoprofen | Quinine  |
| --- | --- | --- |
|  D,L-Chlorpheniramine | Labetalol | Ranitidine  |
|  Chlorpromazine | Loperamide | Salicyclic acid  |
|  Chloroquine | Meprobamate | Serotonin  |
|  Cholesterol | Nalidixic acid | Sulfamethazine  |
|  Clonidine | Naloxone | Tetrahydrozoline  |
|  Cortisone | Naltrexone | Thiamine  |
|  L-Cotinine | Methoxyphenamine | Thioridazine  |
|  Creatinine | Naproxen | D,L-Tyrosine  |
|  Deoxycortisterone | Niacinamide | Triamterene  |
|  Dextromethorphan | Nifedipine | Trifluoperazine  |
|  Diclofenac | Norethindrone | Trimethoprim  |
|  Diflunisal | D-Norpropoxyphene | Tyramine  |
|  Digoxin | Noscapine | D,L-Tryptophan  |
|  Diphenhydramine | D,L-Octopamine | Uric acid  |
|  Ecgonine methyl ester | Oxalic acid | Verapamil  |
|  L-ψ-Ephedrine | Oxolinic acid | Zomepirac  |

The sponsor tested the effects of varying pH and specific gravity on drug positive and negative urine. The pH and specific gravity-adjusted urine samples were found not to interfere with the tests at pH range from 3.0 to 9.0 and specific gravity range from 1.001 to 1.040.

f. Assay cut-off:

Characterization of how the device performs analytically around the claimed cutoff concentration is described in the precision section, M.1.a., above.

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor performed the method comparison study by comparing the performance of the devices to GC/MS results. A total of 340 clinical urine samples were distributed and tested across three sites with two operators at each site. Urine samples were blind-labeled for the testing and drug concentrations were determined by GC/MS. Results are summarized below:

Method comparison data – Test Card

|   | No Drug Present | Near Cutoff Negative (between -50% cutoff and +50%) | Near Cutoff Negative (between cutoff and +50%) | High Positive (> +50% cutoff) | % Agreement with GC/MS |   | Overall% Agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |   |   |  Negative | Positive  |   |

{9}

|   |   |  | cutoff) | cutoff) |  |  |  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  AMP | + | 0 | 1 | 9 | 40 | 98% | 98% | 98%  |
|   |  - | 40 | 9 | 1 | 0  |   |   |   |
|  MET | + | 0 | 1 | 8 | 40 | 98% | 96% | 97%  |
|   |  - | 40 | 9 | 2 | 0  |   |   |   |
|  MOP | + | 0 | 2 | 10 | 40 | 96% | 100% | 98%  |
|   |  - | 40 | 8 | 0 | 0  |   |   |   |
|  COC | + | 0 | 1 | 8 | 40 | 98% | 96% | 97%  |
|   |  - | 40 | 9 | 2 | 0  |   |   |   |
|  THC | + | 0 | 0 | 8 | 40 | 100% | 96% | 98%  |
|   |  - | 40 | 10 | 2 | 0  |   |   |   |

Summary of Discordant Results - Test Card:

|  Sample | Dug Test | Results Recorded | GC/MS Value (ng/mL)  |
| --- | --- | --- | --- |
|  844591 | AMP 1000 | Positive | 952  |
|  545390 | AMP 1000 | Negative | 1030  |
|  960940 | MET 1000 | Positive | 982  |
|  860829 | MET 1000 | Negative | 1054  |
|  610670 | MET 1000 | Negative | 1060  |
|  572595 | MOP 300 | Positive | 284  |
|  898906 | MOP 300 | Positive | 286  |
|  699527 | COC 300 | Positive | 285  |
|  710595 | COC 300 | Negative | 322  |
|  491069 | COC 300 | Negative | 330  |
|  494372 | THC 50 | Negative | 54.3  |
|  801073 | THC 50 | Negative | 55.0  |

Method comparison data - Urine Cup

|   | No Drug Present | Near Cutoff Negative (between -50% cutoff and cutoff) | Near Cutoff Negative (between cutoff and +50% cutoff) | High Positive (> +50% cutoff) | % Agreement with GC/MS |   | Overall% Agreement with GC/MS  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |   |   |  Negative | Positive  |   |   |
|  AMP | + | 0 | 1 | 9 | 40 | 98% | 98% | 98%  |
|   |  - | 40 | 9 | 1 | 0  |   |   |   |
|  MET | + | 0 | 1 | 8 | 40 | 98% | 96% | 97%  |
|   |  - | 40 | 9 | 2 | 0  |   |   |   |
|  MOP | + | 0 | 2 | 10 | 40 | 96% | 100% | 98%  |

{10}

11

|   | - | 40 | 8 | 0 | 0 |  |  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  COC | + | 0 | 0 | 8 | 40 | 100% | 96% | 98%  |
|   |  - | 40 | 10 | 2 | 0  |   |   |   |
|  THC | + | 0 | 0 | 8 | 40 | 100% | 96% | 98%  |
|   |  - | 40 | 10 | 2 | 0  |   |   |   |

Summary of Discordant Results – Urine Cup:

|  Sample | Dug Test | Results Recorded | GC/MS Value (ng/mL)  |
| --- | --- | --- | --- |
|  844591 | AMP 1000 | Positive | 952  |
|  545390 | AMP 1000 | Negative | 1030  |
|  960940 | MET 1000 | Positive | 982  |
|  860829 | MET 1000 | Negative | 1054  |
|  610670 | MET 1000 | Negative | 1060  |
|  572595 | MOP 300 | Positive | 284  |
|  898906 | MOP 300 | Positive | 286  |
|  710595 | COC 300 | Negative | 322  |
|  491069 | COC 300 | Negative | 330  |
|  494372 | THC 50 | Negative | 54.3  |
|  801073 | THC 50 | Negative | 55.0  |

b. Matrix comparison:

Not applicable. This device is for use with urine samples only.

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):

The sponsor conducted a study with 300 untrained lay users. A total of 175 males and 125 females from ages of 18 to 47 with a variety of educational background participated in the study at 3 sites. The blind-labeled urine samples were spiked to the following concentrations with 2-5 drugs: negative; 50%, 75%, 125%, 150%, and 200%.

Each lay-user received one test card and one urine cup to test. For each device format (card and cup), a lay-user received a package insert, one blind labeled aliquot, and one device. Each blind-labeled urine sample was tested only once with each device

{11}

format. All samples were verified by GC/MS, and the results of lay-user were compared to those of GC/MS. The results are summarized below:

Summary of Lay-user Results - Test Card

|  Drug | Results | Drug Concentration |   |   |   |   |   | Agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Negative | -50% | -25% | +25% | +50% | +100%  |   |
|  AMP | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  MET | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  MOP | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  COC | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  THC | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |

Summary of Lay-user Results - Urine Cup

|  Drug | Results | Drug Concentration |   |   |   |   |   | Agreement with GC/MS  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Negative | -50% | -25% | +25% | +50% | +100%  |   |
|  AMP | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  MET | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  MOP | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  COC | + | 0 | 0 | 0 | 20 | 40 | 20 | 100%  |
|   |  - | 180 | 20 | 20 | 0 | 0 | 0  |   |
|  THC | + | 0 | 0 | 0 | 19 | 40 | 20 | 99.7%  |
|   |  - | 180 | 20 | 20 | 1 | 0 | 0  |   |

Each lay-user was also given an English language questionnaire to assess the readability of the labeling and  $100\%$  of users indicated that the device instructions can be easily followed.

# 4. Clinical cut-off:

Not applicable

# 5. Expected values/Reference range:

Not applicable

{12}

N. Proposed Labeling:

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

O. Conclusion:

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

13

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K152590](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K152590)

**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