← Product Code [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG) · K102779

# EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C (K102779)

_Siemens Healthcare Diagnostics, Inc. · DJG · Mar 18, 2011 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K102779

## Device Facts

- **Applicant:** Siemens Healthcare Diagnostics, Inc.
- **Product Code:** [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG.md)
- **Decision Date:** Mar 18, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3650
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers. Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS. The Emit® II Plus 6-Acetylmorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectroscopy (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. Emit® II Plus 6-AM/Ecstasy Calibrators/Controls: When used as Calibrators, the materials are for the calibration of the Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assays. When used as Controls, the materials may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs.

## Device Story

Homogeneous enzyme immunoassay for detection of 6-acetylmorphine in human urine; utilizes two-reagent system (mouse monoclonal antibodies, G6P, NAD, and 6-AM labeled rG6PDH). Operates on clinical chemistry analyzers; measures enzymatic rates at 340 nm. Provides qualitative or semiquantitative results; requires confirmation by GC/MS. Used in clinical laboratories by trained personnel. Results assist in identifying heroin metabolite presence; clinical judgment required for interpretation.

## Clinical Evidence

Method comparison study using 105 unaltered human urine samples analyzed by Emit® II Plus 6-Acetylmorphine Assay vs. GC/MS. Qualitative agreement was 98% for positives and 100% for negatives. Semiquantitative agreement was 98% for positives and 100% for negatives. One discordant result reported.

## Technological Characteristics

Homogeneous enzyme immunoassay; R1 liquid (monoclonal antibodies, G6P, NAD); R2 lyophilized (6-AM labeled rG6PDH). Requires chemistry analyzer with 340 nm measurement capability. Calibrators/Controls are human urine-based. Storage 2–8°C.

## Regulatory Identification

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

## Special Controls

*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

## Predicate Devices

- Microgenics CEDIA® DAU 6-Acetylmorphine Assay (k001178)
- Siemens Healthcare Diagnostics Inc. Emit® II Plus Ecstasy Calibrators / Controls Levels 1 – 4 (k043028)

## Submission Summary (Full Text)

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

A. 510(k) Number:
k102779

B. Purpose for Submission:
New device

C. Measurand:
6-Acetylmorphine

D. Type of Test:
Qualitative and semi-quantitative immunoassay

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
Emit® II Plus 6-Acetylmorphine Assay
Emit® II Plus 6-AM / Ecstasy Calibrators
Emit® II Plus 6-AM / Ecstasy Controls

G. Regulatory Information:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  DJG | II | 862.3650 - Opiate test system | 91 - Toxicology  |
|  DKB | II | 862.3200 - Clinical toxicology calibrator | 91 - Toxicology  |
|  DIF | I, reserved | 862.3280 - Clinical toxicology control material | 91 - Toxicology  |

H. Intended Use:

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

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2. Indication(s) for use:

Emit® II Plus 6-Acetylmorphine Assay:

The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS.

The Emit® II Plus 6-Acetylmorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectroscopy (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Emit® II Plus 6-AM/Ecstasy Calibrators/Controls:

When used as Calibrators, the materials are for the calibration of the Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assays.

When used as Controls, the materials may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs.

3. Special conditions for use statement(s):

For prescription use.

4. Special instrument requirements:

Analyzers capable of maintaining a constant temperature, pipetting samples, mixing reagents, measuring enzymatic rates at 340 nm and timing the reaction accurately can be used to perform this assay. All performance studies were conducted on the Viva-E® analyzer.

I. Device Description:

Assay:

Emit® II Plus 6-Acetylmorphine Assay:

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The Emit® II Plus 6-Acetylmorphine Assay is a homogenous enzyme immunoassay with a 10 ng/mL cutoff. The assay, used for the detection of 6-acetylmorphine (a heroin metabolite) in human urine, utilizes a two-reagent system. The Antibody/Substrate Reagent 1 is a liquid ready-to-use product comprised of mouse monoclonal antibodies to 6-acetylmorphine (6-AM), glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a lyophilized product containing 6-AM labeled bacterial recombinant glucose-6-phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), Hepes buffer, preservatives and stabilizers. Reagent 2 is reconstituted with either deionized or distilled water.

The assay kit consists of Reagent 1 and Reagent 2 in plastic containers (Reagent 2 is provided in a plastic bag with desiccant) and is available in two sizes. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.

Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 – 4:

The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are in-vitro diagnostic products used in the calibration of the Emit® II Plus 6-Acetylmorphine Assay and the Emit® II Plus Ecstasy Assay. These materials may also be used as quality controls based on the specific 6-Acetylmorphine Assay or Ecstasy Assay cutoffs.

The calibrator / control products have the same formulation as the existing Emit® II Plus Ecstasy Calibrators / Controls; cleared under k043028. The matrix is pooled, drug-free, human urine based product containing 6- acetylmorphine (6-AM), methylenedioxymethamphetamine (MDMA) and preservatives. The four levels of product are packaged separately in 15 mL plastic vials with a 10 mL fill per vial. The multi-analyte Calibrators / Controls Levels 1 through 4 contain 6-AM and MDMA at the following concentrations:

|  Calibrator / Control | Targeted 6-AM Concentration (ng/mL) | Targeted MDMA Concentration (ng/mL)  |
| --- | --- | --- |
|  Level 1 | 5 | 150  |
|  Level 2 | 10 | 300  |
|  Level 3 | 15 | 500  |
|  Level 4 | 20 | 1000  |

The Emit® Calibrator / Control Level 0, which contains no drug and was cleared under k993755 will also be used with the Emit® II Plus 6-Acetylmorphine Assay. There was no change to the Calibrator Level 0 product.

J. Substantial Equivalence Information:

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1. Predicate device name:

Microgenics CEDIA® DAU 6-Acetylmorphine Assay
Siemens Healthcare Diagnostics Inc. Emit® II Plus Ecstasy Calibrators / Controls
Levels 1 – 4

2. Predicate 510(k) number:

k001178
k043028

3. Comparison with predicate:

|  Feature | Proposed Device
Emit® II Plus 6-Acetylmorphine Assay | Predicate
CEDIA® DAU 6-Acetylmorphine Assay
(k001178)  |
| --- | --- | --- |
|  Intended Use | The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers. | Same  |
|  Assay Methodology | Homogeneous enzyme immunoassay using Emit® technology | Homogeneous enzyme immunoassay using CEDIA® technology  |
|  Antibody | Mouse monoclonal antibodies to 6-AM | Monoclonal antibodies to 6-AM  |
|  Reference Methodology | GC / MS | Same  |
|  Cutoff | 10 ng/mL | Same  |
|  Sample Type | Human urine | Same  |
|  Reagents: | R1: Liquid – Ready to Use
R2: Lyophilized (Reconstitution required) | R1 & R2: Lyophilized (Reconstitution required)  |
|  Stability (Reconstituted) | R1: Until expiration date on vial
R2: 30 days | R1 & R2: 60 days  |
|  Instrument | Chemistry analyzers capable of maintaining constant reaction temperature, pipetting specimens/reagents and measuring enzyme rates at 340 nm, timing reaction accurately and mixing reagent thoroughly | Clinical chemistry analyzers capable of maintaining constant temperature, pipetting sample, mixing reagents, measuring enzyme rates at 570 nm and timing reaction accurately  |

Comparison of Calibrator Features:

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|  Feature | **Proposed Device**
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls | **Predicate**
Emit® II Plus Ecstasy Calibrators / Controls (k043028)  |
| --- | --- | --- |
|  Indications for Use | Calibrators are used in the calibration of the Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assays. | Same  |
|  Matrix | Human urine based | Same  |
|  Analyte | Contains 6-AM and MDMA | Contains MDMA  |
|  Target Concentrations for 6-AM | Level 1: 5 ng/mL
Level 2: 10 ng/mL
Level 3: 15 ng/mL
Level 4: 20 ng/mL | None  |
|  Preparation | Liquid – Ready to Use | Liquid – Ready to Use  |
|  Storage | 2 – 8°C | 2 – 8°C  |

Comparison of Control Features:

|  Feature | **Proposed Device**
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls | **Predicate**
Emit® II Plus Ecstasy Calibrators / Controls (k043028)  |
| --- | --- | --- |
|  Indications for Use | Controls may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs. | Same  |
|  Analyte | Contains 6-AM and MDMA | Contains MDMA  |
|  Positive Quality Control Level for Qualitative Analysis | Level 4 | Level 4  |

K. Standard/Guidance Document Referenced (if applicable):
CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods
CLSI EP7-A2: Interference Testing in Clinical Chemistry

L. Test Principle:
The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay technique used for the analysis of a specific compound in human urine. The assay is

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based on competition between drug in the specimen and drug labeled with the recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Precision was determined by assaying urine pools spiked with 6-AM for 20 days, 2 runs per day in duplicate (N=80). Precision data were calculated according to the Clinical and Laboratory Standards Institute (CLSI) Guidelines EP5-A2. Results are summarized in tables below:

Qualitative Analysis

|  Urine Pool (ng/mL) | % of cutoff | # of Determinations | Result  |
| --- | --- | --- | --- |
|  Repeatability |  |  |   |
|  0 | -100% | 40 | 40 Negative  |
|  2.5 | -75% | 40 | 40 Negative  |
|  5.0 | -50% | 40 | 40 Negative  |
|  7.5 | -25% | 40 | 40 Negative  |
|  10.0 | cutoff | 40 | 40 Positive  |
|  12.5 | +25% | 40 | 40 Positive  |
|  15.0 | +50% | 40 | 40 Positive  |
|  17.5 | +75% | 40 | 40 Positive  |
|  20.0 | 100% | 40 | 40 Positive  |
|  Within-Lab |  |  |   |
|  0 | -100% | 80 | 80 Negative  |
|  2.5 | -75% | 80 | 80 Negative  |
|  5.0 | -50% | 80 | 80 Negative  |
|  7.5 | -25% | 80 | 80 Negative  |
|  10.0 | cutoff | 80 | 80 Positive  |
|  12.5 | +25% | 80 | 80 Positive  |
|  15.0 | +50% | 80 | 80 Positive  |
|  17.5 | +75% | 80 | 80 Positive  |

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|  Urine Pool (ng/mL) | % of cutoff | # of Determinations | Result  |
| --- | --- | --- | --- |
|  20.0 | 100% | 80 | 80 Positive  |

Semiquantitative Analysis

|  Urine Pool (ng/mL) | % of cutoff | # of Determinations | Result | Mean (ng/mL) | SD | CV (%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Repeatability |  |  |  |  |  |   |
|  0 | -100% | 40 | 40 Negative | 0.9 | 0.10 | N/A  |
|  2.5 | -75% | 40 | 40 Negative | 3.6 | 0.10 | 2.9  |
|  5.0 | -50% | 40 | 40 Negative | 6.0 | 0.12 | 2.0  |
|  7.5 | -25% | 40 | 40 Negative | 8.7 | 0.12 | 1.4  |
|  10.0 | cutoff | 40 | 40 Positive | 11.3 | 0.14 | 1.3  |
|  12.5 | +25% | 40 | 40 Positive | 14.2 | 0.16 | 1.1  |
|  15.0 | +50% | 40 | 40 Positive | 17.0 | 0.15 | 0.9  |
|  17.5 | +75% | 40 | 40 Positive | 19.6 | 0.20 | 1.0  |
|  20.0 | 100% | 40 | 40 Positive | 21.8 | 0.25 | 1.2  |
|  Within-Lab |  |  |  |  |  |   |
|  0 | -100% | 80 | 80 Negative | 0.9 | 0.62 | N/A  |
|  2.5 | -75% | 80 | 80 Negative | 3.6 | 0.47 | 13.3  |
|  5.0 | -50% | 80 | 80 Negative | 6.0 | 0.43 | 7.1  |
|  7.5 | -25% | 80 | 80 Negative | 8.7 | 0.43 | 5.1  |
|  10.0 | cutoff | 80 | 80 Positive | 11.3 | 0.48 | 4.2  |
|  12.5 | +25% | 80 | 80 Positive | 14.2 | 0.50 | 3.5  |
|  15.0 | +50% | 80 | 80 Positive | 17.0 | 0.54 | 3.2  |
|  17.5 | +75% | 80 | 80 Positive | 19.6 | 0.73 | 3.7  |
|  20.0 | 100% | 80 | 80 Positive | 21.8 | 0.89 | 4.1  |

b. Linearity/assay reportable range:

Semiquantitative Results: Drug-free human urine was spiked with concentrations of 6-acetylmorphine at levels across the range of 0 to  $20\mathrm{ng / mL}$ . For each known concentration, drug recovery was calculated using the mean concentration obtained by the Emit® II Plus 6-Acetylmorphine Assay. Semiquantitative results are shown below:

|  Expected 6-AM Concentration (ng/mL) | Mean 6-AM Concentration by Emit® II Plus 6-Acetylmorphine Assay (ng/mL) | Recovery (%)  |
| --- | --- | --- |
|  0 | 0.3 | N/A  |
|  2.5 | 2.8 | 112.2  |
|  5 | 5.7 | 114.7  |

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|  7.5 | 8.2 | 109.8  |
| --- | --- | --- |
|  10 | 10.8 | 108.4  |
|  12.5 | 13.5 | 108.2  |
|  15 | 16.1 | 107.6  |
|  17.5 | 19.0 | 108.7  |
|  20 | 22.7 | 113.5  |

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

A commercially available 6-Acetylmorphine standard solution from Cerilliant Analytical Reference Standards is used and traceable to NIST standard. This standard solution is made into a secondary (lower concentration) stock solution. The secondary stock solution is then spiked into the calibrators and controls to the desired concentration. The concentrations are confirmed by GC/MS.

Stability Studies:

Real time stability studies for both controls and calibrators were conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date for both controls and calibrators:

Real-time stability studies show that when stored at 2-8 °C, open and unopened product is stable for nine months. Real time stability studies are ongoing to support a 12 month stability claim.

d. Detection limit:

Performance at low drug concentrations in the semi-quantitative assay was characterized by determination of recovery (see section b above).

e. Analytical specificity:

Cross-reactivity was established by spiking various concentrations of structurally related compounds into drug-free urine. Results are expressed as a 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 are presented below:

Structurally Related Compounds

|  Compound | Concentration Tested (ng/mL) | Cross-reactivity (%)  |
| --- | --- | --- |
|  Buprenorphine | 1,000,000 | 0.00  |
|  Codeine | 500,000 | 0.00  |

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|  Dextromethorphan | 100,000 | 0.00  |
| --- | --- | --- |
|  Dihydrocodeine | 500,000 | 0.00  |
|  Heroin HCl | 80 | 1.25  |
|  Hydrocodone | 300,000 | 0.00  |
|  Hydromorphone | 100,000 | 0.00  |
|  Imipramine | 200,000 | 0.00  |
|  Levorphanol | 100,000 | 0.00  |
|  Meperidine | 800,000 | 0.00  |
|  Morphine | 100,000 | 0.01  |
|  Morphine-3-Glucuronide | 600,000 | 0.00  |
|  Morphine-6-Glucuronide | 600,000 | 0.00  |
|  Nalorphine | 100,000 | 0.01  |
|  Naloxone | 300,000 | 0.00  |
|  Naltrexone | 300,000 | 0.00  |
|  Norcodeine | 600,000 | 0.00  |
|  Normorphine | 100,000 | 0.00  |
|  Oxycodone | 400,000 | 0.00  |
|  Oxymorphone | 80,000 | 0.00  |

Structurally Unrelated Compounds

The following structurally unrelated compounds were added into drug-free urine spiked into two levels of controls at $\pm 25\%$ of the cutoff concentration. The substances listed in the table below do not yield a false response relative to the cutoff in both qualitative and semiquantitative mode.

|  Compound | Concentration Tested (μg/mL) | Sample Mean (-25% Control) (ng/mL) |   | Sample Mean (+25% Control) (ng/mL)  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative  |
|  10,11-Dihydrocarbamazepine | 85 | Negative | Negative | Positive | Positive  |
|  Acetaminophen | 1000 | Negative | Negative | Positive | Positive  |
|  Acetylsalicylic Acid | 1500 | Negative | Negative | Positive | Positive  |
|  Amitriptyline | 100 | Negative | Negative | Positive | Positive  |
|  Amoxicillin | 500 | Negative | Negative | Positive | Positive  |
|  AZT (Zipovudine) | 2000 | Negative | Negative | Positive | Positive  |
|  Benzoylecgonine | 1000 | Negative | Negative | Positive | Positive  |
|  Brompheniramine | 75 | Negative | Negative | Positive | Positive  |
|  Caffeine | 1000 | Negative | Negative | Positive | Positive  |
|  Captopril | 500 | Negative | Negative | Positive | Positive  |
|  Chlordiazepoxide | 100 | Negative | Negative | Positive | Positive  |
|  Chlorpromazine | 10 | Negative | Negative | Positive | Positive  |
|  Cimetidine | 1000 | Negative | Negative | Positive | Positive  |
|  Clomipramine | 2.5 | Negative | Negative | Positive | Positive  |

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|  Compound | Concentration Tested (μg/mL) | Sample Mean (-25% Control) (ng/mL) |   | Sample Mean (+25% Control) (ng/mL)  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative  |
|  Clonidine | 1000 | Negative | Negative | Positive | Positive  |
|  Cyclobenzaprine | 125 | Negative | Negative | Positive | Positive  |
|  d-Amphetamine | 700 | Negative | Negative | Positive | Positive  |
|  Desipramine | 800 | Negative | Negative | Positive | Positive  |
|  Diazepam | 100 | Negative | Negative | Positive | Positive  |
|  Digoxin | 0.01 | Negative | Negative | Positive | Positive  |
|  Diphenhydramine | 1000 | Negative | Negative | Positive | Positive  |
|  d-Methamphetamine | 500 | Negative | Negative | Positive | Positive  |
|  Doxepine | 100 | Negative | Negative | Positive | Positive  |
|  EDDP | 1000 | Negative | Negative | Positive | Positive  |
|  Enalapril | 500 | Negative | Negative | Positive | Positive  |
|  Fluoxetine | 500 | Negative | Negative | Positive | Positive  |
|  Glutethimide | 500 | Negative | Negative | Positive | Positive  |
|  Haloperidol | 100 | Negative | Negative | Positive | Positive  |
|  Hydroxyzine | 500 | Negative | Negative | Positive | Positive  |
|  Ibuprophen | 1000 | Negative | Negative | Positive | Positive  |
|  Ketamine | 100 | Negative | Negative | Positive | Positive  |
|  Ketorolac Tromethamine | 400 | Negative | Negative | Positive | Positive  |
|  LAAM (L-α-Acetylmethadol) | 25 | Negative | Negative | Positive | Positive  |
|  L-Cotinine | 100 | Negative | Negative | Positive | Positive  |
|  Levofloxacin | 100 | Negative | Negative | Positive | Positive  |
|  Levothyroxine | 50 | Negative | Negative | Positive | Positive  |
|  Lidocaine | 1000 | Negative | Negative | Positive | Positive  |
|  Lormetazepam | 1 | Negative | Negative | Positive | Positive  |
|  LSD | 10 | Negative | Negative | Positive | Positive  |
|  MDMA (Ecstasy) | 1000 | Negative | Negative | Positive | Positive  |
|  Methadone | 500 | Negative | Negative | Positive | Positive  |
|  Methaqualone | 600 | Negative | Negative | Positive | Positive  |
|  NAPA (N-Acetylprocainamide) | 400 | Negative | Negative | Positive | Positive  |
|  Naproxen | 1000 | Negative | Negative | Positive | Positive  |
|  Nicotinic Acid | 500 | Negative | Negative | Positive | Positive  |
|  Nifedipine | 500 | Negative | Negative | Positive | Positive  |
|  Nordiazepam | 100 | Negative | Negative | Positive | Positive  |
|  Nortryptiline | 250 | Negative | Negative | Positive | Positive  |
|  Oxazepam | 300 | Negative | Negative | Positive | Positive  |
|  Perphenazine | 150 | Negative | Negative | Positive | Positive  |
|  Phencyclidine | 1000 | Negative | Negative | Positive | Positive  |
|  Phenobarbital | 500 | Negative | Negative | Positive | Positive  |
|  Phenelzine | 100 | Negative | Negative | Positive | Positive  |

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The following endogenous compounds were added into drug-free urine spiked into two levels of controls at  $\pm 25\%$  of the cutoff concentration. The substances listed in the table below do not yield a false response relative to the cutoff in both qualitative and semiquantitative mode.

Endogenous Substances

|  Substance | Level Tested | Sample Mean (-25% Control) (ng/mL) |   | Sample Mean (+25% Control) (ng/mL)  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative  |
|  Acetone | 1.0 g/dL | Negative | Negative | Positive | Positive  |
|  Ascorbic Acid | 1.5 g/dL | Negative | Negative | Positive | Positive  |
|  Bilirubin, Conjugated | 2.0 mg/dL | Negative | Negative | Positive | Positive  |
|  Bilirubin, | 2.0 mg/dL | Negative | Negative | Positive | Positive  |
|  Creatinine | 1.0 mg/dL | Negative | Negative | Negative | Negative  |
|  Creatinine, | 1.0 mg/dL | Negative | Negative | Negative | Negative  |
|  Creatinine, | 1.0 mg/dL | Negative | Negative | Negative | Negative  |

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|  Unconjugated |  |  |  |  |   |
| --- | --- | --- | --- | --- | --- |
|  Creatinine | 0.5 g/dL | Negative | Negative | Positive | Positive  |
|  Ethanol | 1.0 g/dL | Negative | Negative | Positive | Positive  |
|  Galactose | 10 mg/dL | Negative | Negative | Positive | Positive  |
|  γ-Globulin | 500 mg/dL | Negative | Negative | Positive | Positive  |
|  Glucose | 2.0 g/dL | Negative | Negative | Positive | Positive  |
|  Hemoglobin | 115 mg/dL | Negative | Negative | Positive | Positive  |
|  Human Serum Albumin | 0.5 g/dL | Negative | Negative | Positive | Positive  |
|  Oxalic Acid | 0.1 g/dL | Negative | Negative | Positive | Positive  |
|  Riboflavin | 7.5 mg/dL | Negative | Negative | Positive | Positive  |
|  Sodium Chloride | 6.0 g/dL | Negative | Negative | Positive | Positive  |
|  Urea | 6.0 g/dL | Negative | Negative | Positive | Positive  |

Specific Gravity and pH

Urine samples with specific gravity values ranging from 1.002 to 1.030 and pH values ranging from 4.0 to 10.0 were tested in the presence of 7.5 and 12.5 ng/mL of 6-AM. No interference was observed.

f. Assay cut-off:

Analytical performance of the device around the claimed cutoff is described in precision section (1 a.) above.

2. Comparison studies:

a. Method comparison:

One hundred five (105) samples were analyzed by the Emit® II Plus 6-Acetylmorphine Assay and by GC/MS. Both methods used a cutoff of 10 ng/mL. 22 samples were within +/- 50% of the cutoff by GC/MS.

Forty nine (49) samples showed positive results by both methods, while fifty five (55) samples showed negative results by both methods. One specimen showed a negative result by GC/MS and a positive result by the Emit® II Plus 6-Acetylmorphine Assay.

Qualitative and Semiquantitative Accuracy Summary

|   | GC/MS |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |  LOW NEG
Less than 50%
below the cutoff
(<5 ng/mL) | NEG
Within 50%
below the cutoff
(5.0 ~ 9.9
ng/mL) | POS
Within 50%
above the cutoff
(10.0 ~ 15
ng/mL) | HIGH POS
Greater than
50% above
the cutoff
(>15 ng/mL) | % Agreement  |
|  Qualitative Summary  |   |   |   |   |   |

{12}

13

|  Emit® | POS | 0 | 1 | 15 | 34 | 98%  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  NEG | 49 | 6 | 0 | 0 | 100%  |
|  Semiquantitative Summary  |   |   |   |   |   |   |
|  Emit® | POS | 0 | 1 | 15 | 34 | 98%  |
|   |  NEG | 49 | 6 | 0 | 0 | 100%  |

Discordant Result Summary

|  Cutoff Value (10 ng/mL) | Qualitative Result |   | Semiquantitative Result  |   |
| --- | --- | --- | --- | --- |
|   |  Emit® Assay | GC/MS | Emit® Assay | GC/MS  |
|  Sample # 55 | Positive | 7.8 ng/mL | Positive | 7.8 ng/mL  |

b. Matrix comparison: Test is for 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): Not applicable

4. Clinical cut-off: Not applicable
5. Expected values/Reference range: Not applicable

N. Proposed Labeling:

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

O. Conclusion:

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

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K102779](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K102779)

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