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Emit® II Plus Buprenorphine Assay is a homogeneous enzyme immunoassay with a 5 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative analyses of buprenorphine in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as LC/MS or Permitting laboratories to establish quality control procedures.

The Emit® II Plus Buprenorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/ MS) or LC/MS are the preferred confirmatory methods. 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 Specialty Drug Calibrator/Control Level 1, Emit® II Plus Specialty Drug Calibrator/Control Level 2, Emit® II Plus Specialty Drug Calibrator/Control Level 3, Emit® II Plus Specialty Drug Calibrator/Control Level 4

The Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.

Emit® II Plus Specialty Drug Control Negative and Emit® II Plus Specialty Drug Control Positive

The Emit® II Plus Specialty Drug Control Negative and Control Positive are for use with the Emit® II Plus Buprenorphine Assay.

The Emit® II Plus Buprenorphine assay is a homogeneous enzyme immunoassay with a 5 ng/mL cutoff. The assay, used for the detection of Buprenorphine 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 buprenorphine, 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 liguid. ready-to-use product containing norbuprenorphine labeled bacterial recombinant glucose-6 phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), Hepes buffer, preservatives and stabilizers.

The assay kit consists of Reagent 1 and Reagent 2 in plastic containers and is available in three sizes: large kit (1L), small kit (115 mL), and 28 mL Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Buprenorphine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result.

Emit® II Plus Specialty Drug Calibrators / Controls are in-vitro diagnostic products used in the calibration of the Emit® II Plus Buprenorphine assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff. The matrix is pooled, drug-free, human urine based product containing buprenorphine, preservatives and surfactants. Each level of calibrator is packaged and sold separately, 1 plastic bottle per box, 10 mL in a 15 mL bottle. Values are nominal and are verified with urine based buprenorphine anchor pool and adjusted if needed. The anchor pool levels are verified by LC/MS/MS and are within 10% of nominal drug concentration for levels 2.5 and 5.0 ng/mL and within 5 % of nominal concentrations for levels 15 and 25 ng/mL.

Emit® II Plus Specialty Drug Control Negative and Emit® II Plus Specialty Drug Control Positive are in-vitro diagnostic products are for use with the Emit® II Plus Buprenorphine assay. The matrix is pooled, drug-free, human urine based product containing buprenorphine, preservatives and surfactants. The Control Negative and Control Positive are packaged separately in 15 mL plastic vials with a 10 mL fill per vial. Values are nominal and are verified with urine based buprenorphine anchor pool and adjusted if needed. Anchor pool levels are verified by LC/MS/MS.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Emit® II Plus Buprenorphine Assay, Emit® II Plus Specialty Drug Calibrator/Control Level 1-4, Emit® II Plus Specialty Drug Control Negative/Positive.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numbered or bulleted points in the provided document. However, based on the performance data presented, we can infer the criteria that the device aimed to meet for substantial equivalence. The document primarily focuses on demonstrating performance against expected standards for an in vitro diagnostic device for drug screening, particularly a qualitative and semi-quantitative assay.

Here's a table summarizing the inferred acceptance criteria and the device's performance:

• Consistent classification (Negative/Positive) for concentrations significantly below/above cutoff.
• Acceptable level of concordant/discordant results near the cutoff for both qualitative and semi-quantitative modes. | Precision: Qualitative Analysis (5 ng/mL cutoff)
• 0, 2.5, 3, 3.75 ng/mL (below cutoff): 80 Negative out of 80 results (100% agreement).
• 5 ng/mL (cutoff): 25 Negative / 55 Positive (68.75% positive, 31.25% negative). This indicates some variability at the exact cutoff, which is typical for immunoassays.
• 6.25, 7, 7.5, 10 ng/mL (above cutoff): 80 Positive out of 80 results (100% agreement).
• Additional Precision Study:
  • 1.25 ng/mL (-75% cutoff): 80 Negative out of 80 results (100% agreement).
  • 8.75 ng/mL (+75% cutoff): 80 Positive out of 80 results (100% agreement).
    Overall, good precision away from the cutoff, expected variability at the cutoff. |
    | Precision (Semi-quantitative Analysis) - Agreement near cutoff
• Consistent classification (Negative/Positive) and semi-quantitative results for concentrations significantly below/above cutoff. | Precision: Semi-quantitative Analysis (5 ng/mL cutoff)
• 0, 2.5, 3, 3.75 ng/mL (below cutoff): 80 Negative out of 80 results (100% agreement).
• 5 ng/mL (cutoff): 25 Negative / 55 Positive (68.75% positive, 31.25% negative).
• 6.25, 7, 7.5, 10 ng/mL (above cutoff): 80 Positive out of 80 results (100% agreement).
• Additional Precision Study:
  • 1.25 ng/mL (-75% cutoff): 80 Negative out of 80 results (100% agreement).
  • 8.75 ng/mL (+75% cutoff): 80 Positive out of 80 results (100% agreement).
    Results mirror qualitative analysis, demonstrating consistent semi-quantitative performance. |
    | Specificity and Cross-reactivity - Buprenorphine Metabolites
• Appropriate cross-reactivity with buprenorphine and its primary active metabolite (norbuprenorphine).
• Low to no cross-reactivity with inactive glucuronide metabolites. | Buprenorphine Metabolite Recovery
• Buprenorphine (5 ng/mL): 103.2% recovery (5.2 ng/mL).
• Norbuprenorphine (5 ng/mL): 92.6% recovery (4.6 ng/mL).
• Buprenorphine Glucuronide (1000 ng/mL): 0.1% cross-reactivity (0.9 ng/mL).
• Norbuprenorphine Glucuronide (1000 ng/mL): 0.1% cross-reactivity (1.2 ng/mL).
  Demonstrates good detection of buprenorphine and norbuprenorphine, minimal interference from inactive glucuronide metabolites. |
  | Specificity and Cross-reactivity - Structurally Related Compounds
• No significant false positives from a panel of common opioids and other structurally related compounds at high concentrations. | Cross-reactivity with Structurally Related Compounds
• Over 20 common opioids and related compounds (e.g., 6-acetylcodeine, codeine, heroin, morphine, oxycodone) were tested at 100,000 ng/mL.
• All tested compounds showed "Negative" qualitative results and "

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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.

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.

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.

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