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510(k) Data Aggregation
(115 days)
The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Barbiturates Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/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 results are used.
Immunalysis Multi-Drug Calibrators:
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.
The Immunalysis Barbiturates Urine Enzyme Immunoassay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes a recombinant antibody to Secobarbital, a mouse monoclonal antibody to Secobarbital, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes Barbiturates labeled with glucose-6phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as a preservative.
Immunalysis Multi-Drug Calibrators are included as part of the test system and provided separately. The calibrator kit includes four levels of drugs and a negative calibrator in a ready-touse format. Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates spectrophotometrically at 340nm can be used to perform the assay.
The Immunalysis Barbiturates Urine Enzyme Immunoassay uses barbiturates recombinant and monoclonal antibody. The assay is based on the competition of Barbiturates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.
Here's a breakdown of the acceptance criteria and study information for the Immunalysis Barbiturates Urine Enzyme Immunoassay:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets within the provided text. However, the studies demonstrate the performance of the device in various metrics, and the conclusion states that the device is "substantially equivalent to the legally marketed predicate device for its intended use." This implies that the performance shown met the, albeit unstated, acceptance criteria for substantial equivalence to the predicate device.
For this analysis, I will infer the acceptance criteria from the context of how the results are presented, specifically the aim of demonstrating that the cutoff serves as a boundary between negative and positive interpretations, demonstrating appropriate cross-reactivity and non-interference, and showing high agreement with LC/MS-MS.
| Test / Performance Characteristic | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (Precision/Cutoff Characterization) | Clear discrimination around the 200 ng/mL cutoff (e.g., concentrations significantly below cutoff are consistently negative, significantly above consistently positive, at cutoff shows mixed results). | - 0-150 ng/mL: 80/80 Negative (100%) - 200 ng/mL (Cutoff): 33/80 Negative, 47/80 Positive - 250-400 ng/mL: 80/80 Positive (100%) |
| Semi-Quantitative Analysis (Precision/Cutoff Characterization) | Clear discrimination around the 200 ng/mL cutoff and mixed results at cutoff. | - 0-150 ng/mL: 80/80 Negative (100%) - 200 ng/mL (Cutoff): 23/80 Negative, 57/80 Positive - 250-400 ng/mL: 80/80 Positive (100%) |
| Specificity and Cross-Reactivity (Structurally Related Compounds) | Detect target compound (Secobarbital) at cutoff with 100% cross-reactivity; minimal or varying cross-reactivity for other barbiturates, with higher concentrations needed for positive results; Negative results for Phenytoin. | - Secobarbital: 100% Cross-Reactivity - Other Barbiturates: Cross-reactivity % varied from 0.3% (Hexobarbital, Mephobarbital) to 105.3% (Alphenal, Butobarbital) - Phenytoin (100,000 ng/mL): Negative, <0.2% Cross-Reactivity |
| Interference (Structurally Unrelated Compounds) | No interference (Negative at -25% cutoff, Positive at +25% cutoff). | All tested compounds (over 60) showed: - -25% Cutoff (150 ng/mL): Consistently Negative - +25% Cutoff (250 ng/mL): Consistently Positive |
| Interference (Endogenous Compounds) | No interference (Negative at -25% cutoff, Positive at +25% cutoff). | All tested compounds (16) showed: - -25% Cutoff (150 ng/mL): Consistently Negative - +25% Cutoff (250 ng/mL): Consistently Positive |
| Boric Acid Interference | No interference at concentrations around the cutoff. | - 1% w/v Boric Acid at -25% Cutoff (150 ng/mL): Negative - 1% w/v Boric Acid at +25% Cutoff (250 ng/mL): Negative - (Further tested): 1% w/v Boric Acid at -50% Cutoff (100 ng/mL) and +50% Cutoff (300 ng/mL): Negative |
| pH Interference | No interference across a physiological pH range. | - pH 3.0 to 11.0: - At -25% Cutoff (150 ng/mL): All Negative - At +25% Cutoff (250 ng/mL): All Positive |
| Specific Gravity Interference | No interference across a physiological specific gravity range. | - SG 1.000 to 1.030: - At -25% Cutoff (150 ng/mL): All Negative - At +25% Cutoff (250 ng/mL): All Positive |
| Linearity/Recovery | Good linearity and recovery across a relevant concentration range. | - Recovery within 89.3% to 104.9% for expected concentrations from 100 ng/mL to 1100 ng/mL. |
| Method Comparison (LC/MS-MS) | High agreement (e.g., 100%) with a confirmatory method (LC/MS-MS) for positive and negative samples outside of the equivocal zone. | - Qualitative Positive: 100% Agreement (for >200 ng/mL and 200-300 ng/mL) - Qualitative Negative: 100% Agreement (for <200 ng/mL) - Semi-Quantitative Positive: 100% Agreement (for >200 ng/mL and 200-300 ng/mL) - Semi-Quantitative Negative: 100% Agreement (for <200 ng/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Cutoff Characterization Study: 80 drug-free urine samples spiked with secobarbital. Test samples were within the USA (implied as no other country is mentioned and this is an FDA submission). The study appears to be prospective (controlled spiking to evaluate performance).
- Specificity and Cross-Reactivity: Not explicitly stated as a "sample size" in terms of patient samples. Structurally similar compounds were spiked into drug-free urine. Data provenance is implied to be within the USA. This is a prospective study design.
- Interference (Structurally Unrelated & Endogenous Compounds): Not explicitly stated as a "sample size." Potential interferents were spiked into drug-free urine containing secobarbital. Data provenance is implied to be within the USA. This is a prospective study design.
- Boric Acid Interference: Not explicitly stated as a "sample size." Boric acid was spiked into drug-free urine containing secobarbital. Data provenance is implied to be within the USA. This is a prospective study design.
- pH Interference: Not explicitly stated as a "sample size." Test samples were prepared in drug-free urine containing secobarbital at various pH levels. Data provenance is implied to be within the USA. This is a prospective study design.
- Specific Gravity Interference: Not explicitly stated as a "sample size." Test samples were prepared in drug-free urine containing secobarbital at various specific gravity levels. Data provenance is implied to be within the USA. This is a prospective study design.
- Linearity/Recovery: Not explicitly stated as a "sample size" in terms of patient samples. Drug-free urine was spiked with secobarbital and serially diluted. Each pool was tested in triplicate. Data provenance is implied to be within the USA. This is a prospective study design.
- Method Comparison: 96 de-identified, unaltered leftover clinical urine samples. Data provenance is implied to be from clinical testing laboratories within the USA (as no other country is mentioned and this is an FDA submission). The study is retrospective, as it used "leftover clinical urine samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No human experts were used to establish the ground truth for this device. The ground truth was established by:
- Mass Spectrometry (MS/LC-MS/MS): This is considered the "gold standard" for confirmatory drug testing.
- Controlled spiking: For precision, specificity, interference, pH, specific gravity, and linearity studies, known concentrations of the drug or interfering substances were added to drug-free urine samples. This provides a precisely known "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As the ground truth was established by mass spectrometry or controlled spiking, there was no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic immunoassay, not an imaging device requiring human reader interpretation. Therefore, assessing how human readers improve with AI vs without AI assistance is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone performance evaluations of the assay system itself. The device is an automated immunoassay intended for laboratories and provides preliminary analytical test results, which may then be confirmed by other methods (like GC-MS or LC-MS/MS). The performance reported is of the immunoassay system operating without human interpretation involved in the result generation process, other than standard laboratory procedures.
7. The Type of Ground Truth Used
The ground truth used was primarily:
- Mass Spectrometry (LC-MS/MS): Used to confirm concentrations in spiked samples for precision/cutoff determination and as the comparator method for the method comparison study.
- Known concentrations via controlled spiking: For studies on precision/cutoff, specificity, interference (structurally unrelated, endogenous, boric acid), pH, specific gravity, and linearity, the "ground truth" was the precisely known concentration of the drug or interferent added to a drug-free matrix.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of an algorithm or AI. This device is an immunoassay, which does not typically involve machine learning training sets in the same way an AI-based diagnostic might. The device formulation and parameters would have been developed and optimized, but this isn't described as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the context of AI/machine learning is not relevant for this immunoassay device. The scientific principles of antigen-antibody reactions and enzyme kinetics underpin the assay's function, rather than data-driven learning.
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