(95 days)
The Cozart EIA Cocaine Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for cocaine and metabolites in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/ml. in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample.
This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.
The Cozart EIA Cocaine Oral Fluid Kit is a laboratory based test for the detection of cocaine and metabolites in human oral fluid using a cutoff equivalent to 30ng/mL. The Cozart EIA Cocaine Oral Fluid Kit is a competitive ELISA for the detection of cocaine and its metabolites in human oral fluid. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 5, 10 and 50ng/ml benzoylecgonine in oral fluid matrix).
Here's a summary of the acceptance criteria and study details for the Cozart EIA Cocaine Oral Fluid Kit, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments / Context |
|---|---|---|
| Method Comparison | 96% overall agreement | Compared to GC/MS (Gas Chromatography/Mass Spectrometry), the gold standard. |
| Precision | CVs less than 9% (kit) | Acceptable for qualitative manual ELISA assay (CVs less than 10% acceptable). |
| Total precision (kit) CVs less than 11% | ||
| Sensitivity | 1.8 ng/mL | Detection limit for cocaine in oral fluid. |
| Specificity | No cross-reactivity with 29 potential interferents | Three out of four related compounds showed some cross-reactivity. |
| Cutoff Concentration Validation | Absorbances for 5 ng/mL higher than 10 ng/mL cutoff calibrator; Absorbances for 15 ng/mL lower than 10 ng/mL cutoff calibrator | Confirmed appropriate response around the 10 ng/mL cutoff. |
| Interference Studies | No interference observed | Tested against alcohol, sample adequacy indicator dye, hemoglobin, smoking, coffee, tea, water, food, orange juice, hard candy, chewing gum, and mouthwash. |
| Stopped Assay Stability | Must be read within 15 minutes at 450 nm | Absorbance readings at various time points (0, 5, 10, 15, 30, 45, 60 minutes) showed stability up to 15 minutes. |
| Assay Drift | Little change across the plate | Sample addition must occur within 25 minutes. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 177 samples.
- Data Provenance: Not explicitly stated, but the context of clinical and forensic samples suggests human samples. The country of origin is not specified, but the manufacturer is based in the UK. The study appears to be retrospective, as existing samples were tested.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable for this type of in-vitro diagnostic (IVD) device. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method, not human expert consensus, for drug detection.
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Adjudication Method for the Test Set:
- Not applicable. The reference method (GC/MS) served as the definitive ground truth, and the device's results were compared directly to it. There was no mention of human adjudication between different readers or methods beyond the GC/MS.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This device is an in-vitro diagnostic kit, not an imaging or diagnostic algorithm requiring human interpretation of output.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this was a standalone performance study. The Cozart EIA Cocaine Oral Fluid Kit is a laboratory-based test that provides a qualitative result based on its biochemical reactions and spectrophotometric reading. Its performance was evaluated directly against GC/MS without human intervention in the interpretation of the kit's results.
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The Type of Ground Truth Used:
- analytical reference method, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The text explicitly states: "The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS)." and "96% overall agreement as compared with GC/MS". GC/MS is widely considered the "gold standard" for confirmatory drug testing.
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Sample Size for the Training Set:
- Not explicitly stated. The document describes a "method comparison" study as the primary performance evaluation. For a competitive ELISA kit, internal calibration and validation (which might involve a "training" equivalent) would have been performed by the manufacturer during its development, but details regarding a distinct "training set" sample size are not provided in this 510(k) summary.
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How the Ground Truth for the Training Set Was Established:
- Not explicitly stated. Given that performance for the test set was established against GC/MS, it is highly probable that any internal development, calibration, or "training" (if applicable for this type of device) would also have referenced GC/MS or highly purified standards of cocaine and its metabolites at known concentrations.
§ 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).