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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.

Device Description

Emit® II Plus 6-Acetylmorphine Assay:
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 liguid 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:
Level 1: Targeted 6-AM Concentration (ng/mL) 5, Targeted MDMA Concentration (ng/mL) 150
Level 2: Targeted 6-AM Concentration (ng/mL) 10, Targeted MDMA Concentration (ng/mL) 300
Level 3: Targeted 6-AM Concentration (ng/mL) 15, Targeted MDMA Concentration (ng/mL) 500
Level 4: Targeted 6-AM Concentration (ng/mL) 20, Targeted MDMA Concentration (ng/mL) 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- AcetyImorphine Assay. There was no change to the Calibrator Level 0 product.

AI/ML Overview

Acceptance Criteria and Device Performance for Emit® II Plus 6-Acetylmorphine Assay

The Emit® II Plus 6-Acetylmorphine Assay is an in-vitro diagnostic device designed for the qualitative and/or semiquantitative analysis of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. The device's performance was evaluated against a predicate device and confirmed using Gas Chromatography/Mass Spectrometry (GC/MS).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Emit® II Plus 6-Acetylmorphine Assay are implicitly defined by its agreement with GC/MS results for qualitative and semiquantitative analysis, particularly around the 10 ng/mL cutoff. The reported performance demonstrates high agreement with GC/MS.

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Qualitative Agreement	High agreement (ideally >95%) with GC/MS for positive and negative samples, especially near the cutoff.	POS: 98% with GC/MS (for samples >= 10 ng/mL) NEG: 100% with GC/MS (for samples < 10 ng/mL)
Semiquantitative Agreement	High agreement with GC/MS, particularly for distinguishing between concentrations below and above the cutoff.	POS: 98% with GC/MS (for samples >= 10 ng/mL) NEG: 100% with GC/MS (for samples < 10 ng/mL)
Discordant Results	Minimal discordant results, with clear explanations for any discrepancies.	One discordant sample (#55): Emit® Assay semiquantitative result was 16.3 ng/mL (POS) while GC/MS was 7.8 ng/mL (NEG).

2. Sample Size and Data Provenance

Sample Size for Test Set: One-hundred five (105) unaltered human urine samples were used for the method comparison study.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "unaltered human urine samples," implying prospective collection for the study purpose, but this is not explicitly confirmed, nor is it stated whether the samples were de-identified or how they were handled.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), not by expert interpretation of the assay results.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The comparison was directly between the Emit® II Plus 6-Acetylmorphine Assay and GC/MS as the reference method. There was no mention of multiple readers or an adjudication process for the interpretation of the assay results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is not relevant for an automated diagnostic assay where human interpretation is not the primary output for diagnostic decision-making. The assay provides a quantitative/semiquantitative result.

6. Standalone (Algorithm Only) Performance

Standalone Performance Done: Yes. The reported performance metrics (qualitative and semiquantitative agreement with GC/MS) represent the standalone performance of the Emit® II Plus 6-Acetylmorphine Assay. There is no human-in-the-loop component mentioned that would alter the assay's output for diagnostic purposes.

7. Type of Ground Truth Used

Type of Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). This is explicitly stated as "the preferred confirmatory method" and the method against which the Emit® II Plus 6-Acetylmorphine Assay was compared.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The document describes a comparison study for a fully developed diagnostic assay. Information regarding the development and training (if any, for internal algorithm optimization) of the immunoassay itself is not provided in this summary. This is a premarket notification for a predicate device, focusing on its performance characteristics.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as detailed training set information is not provided.

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