(280 days)
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 4 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Oral Fluid 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The LZI Oral Fluid 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Oral Fluid 6-Acetylmorphine assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, 6-Acetylmorphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound 6-Acetylmorphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The R1 solution contains mouse monoclonal anti-6-Acetylmorphine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with 6-Acetylmorphine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay calibrators and controls designated for use at the 4 ng/mL cutoffs contain 0, 2, 4, 6, 10, and 20 ng/mL of 6-Acetylmorphine in synthetic oral fluid matrix with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The provided document is a 510(k) premarket notification for the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay (EIA), its calibrators, and controls. This device is an in-vitro diagnostic test for detecting 6-Acetylmorphine in human oral fluid.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a separate section with numerical thresholds for performance metrics. Instead, it presents performance characteristic studies (Precision, Analytical Recovery, Method Comparison), and the results of these studies implicitly demonstrate the device's acceptable performance for determining substantial equivalence to a predicate device. The primary performance characteristic related to diagnostic accuracy is the Method Comparison with clinical samples.
Here's a table summarizing the reported device performance, particularly focusing on the "Method Comparison" results, as this is the most direct measure of accuracy against a reference method:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay) |
|---|---|---|
| Semi-Quantitative Accuracy (Clinical Samples): | ||
| Agreement with GC/MS (Positive) | High agreement expected | 99.0% agreement with GC/MS for positive samples (10 near cutoff positive and 89 high positive samples correctly identified by immunoassay as positive). |
| Agreement with GC/MS (Negative) | High agreement expected | 100.0% agreement with GC/MS for negative samples (20 negative, 14 |
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).