(91 days)
The Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL on the Alinity c analyzer.
The semiquantitative application is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The 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 Spectrometry (GC/MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine samplefor a fixed amount of specific antibody binding sites. In the presence of free drug fromthe sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
The assay consists of reagents (A and E).
Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative.
Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.
The provided text describes the analytical performance studies for the DRI Cocaine Metabolite Assay, an in vitro diagnostic device, rather than an AI-powered medical device requiring human-in-the-loop studies or expert consensus for ground truth. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this submission.
However, I can extract information related to the acceptance criteria and performance of this in vitro diagnostic device.
Here's a breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the results presented in the analytical performance studies. The device is expected to accurately categorize samples as negative or positive relative to defined cutoffs (150 ng/mL or 300 ng/mL) and demonstrate good precision, linearity, and minimal interference.
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Study/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | High concordance for samples spiked above and below the cutoff concentrations; variable results around the cutoff are expected but within an acceptable range. | 150 ng/mL cutoff: |
- Below cutoff (-100% to -25%): 100% Negative (e.g., 120/0 or 119/0)
- Above cutoff (+25% to +100%): 100% Positive (0/120 or 0/119)
- At cutoff (150 ng/mL): Qualitative: 76/44 (N/P), Semi-Quantitative: 73/47 (N/P)
300 ng/mL cutoff: - Below cutoff (-100% to -25%): 100% Negative (e.g., 120/0 or 119/0)
- Above cutoff (+25% to +100%): 100% Positive (0/120)
- At cutoff (300 ng/mL): Qualitative: 44/76 (N/P), Semi-Quantitative: 42/77 (N/P) |
| Spike Recovery | Samples spiked below cutoff should be negative; samples spiked above cutoff should be positive. | 150 ng/mL cutoff: - 112.5 ng/mL (below C/O): 25/25 Negative
- 187.5 ng/mL (above C/O): 25/25 Positive
300 ng/mL cutoff: - 225 ng/mL (below C/O): 25/25 Negative
- 375 ng/mL (above C/O): 25/25 Positive |
| Linearity | Observed concentrations should be within an acceptable recovery range of expected concentrations across the assay range. | Excellent linearity demonstrated over the range 0 to 1032.2 ng/mL. Percent recovery from 95.7% to 111.4%. |
| Method Comparison (Accuracy) | High agreement (concordance) with the confirmatory method (LC-MS/MS). Discordant results should be minimal and explainable. | 150 ng/mL cutoff (Semi-Quantitative & Qualitative): - Agreement among Positives: 100% (51/51)
- Agreement among Negative: 98% (49/50)
- 1 discordant result (Device: Positive, LC-MS/MS: 134 ng/mL, which is below 150 ng/mL cutoff)
300 ng/mL cutoff (Semi-Quantitative & Qualitative): - Agreement among Positives: 100% (50/50)
- Agreement among Negative: 96% (48/50)
- 2 discordant results (Device: Positive, LC-MS/MS: 268 ng/mL and 211 ng/mL, both below 300 ng/mL cutoff) |
| Specificity (Cross-Reactivity) | Minimal cross-reactivity with structurally related or unrelated compounds at specified concentrations. | Cocaine and metabolites: - Benzoylecgonine: 100%
- Cocaine: 0.6%
- Cocaethylene: 0.5%
- Ecgonine: 0.17-0.19%
- Ecgonine Methyl Ester:
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).