(380 days)
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of oxycodone in human oral fluid with clinical analyzers. This assay is calibrated against oxycodone.
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 SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
The SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is an in vitro test to detect the presence of oxycodone in human oral fluid samples collected by Quantisal II Oral Fluid Collection Device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Qualitative Mode) - Quantisal | Consistently identify negative samples below cutoff and positive samples above cutoff, with mixed results around cutoff. | At -100%, -75%, -50%, -25% of cutoff (0, 7.5, 15, 22.5 ng/mL): All 60 determinations were Negative. |
| At Cutoff (30 ng/mL): 31 Negative / 29 Positive. | ||
| At +25%, +50%, +75%, +100% of cutoff (37.5, 45, 52.5, 60 ng/mL): All 60 determinations were Positive. | ||
| Precision (Semi-Quantitative Mode) - Quantisal | Mean concentrations should be close to expected values, with consistent negative/positive calls. | At -100% (0 ng/mL): Mean Conc. -0.2 ng/mL, 60 Negative. |
| At -50% (15 ng/mL): Mean Conc. 16.7 ng/mL, 60 Negative. | ||
| At -25% (22.5 ng/mL): Mean Conc. 24.3 ng/mL, 60 Negative. | ||
| At Cutoff (30 ng/mL): Mean Conc. 32.3 ng/mL, 16 Negative / 44 Positive. | ||
| At +25% (37.5 ng/mL): Mean Conc. 42.1 ng/mL, 60 Positive. | ||
| At +50% (45 ng/mL): Mean Conc. 53.3 ng/mL, 60 Positive. | ||
| At +75% (52.5 ng/mL): Mean Conc. 64.3 ng/mL, 60 Positive. | ||
| At +100% (60 ng/mL): Mean Conc. 76.3 ng/mL, 60 Positive. | ||
| Precision (Qualitative Mode) - Quantisal II Pad A | Consistently identify negative samples below cutoff and positive samples above cutoff, with mixed results around cutoff. | At -100%, -75%, -50%, -25% of cutoff (0, 7.5, 15, 22.5 ng/mL): All 60 determinations were Negative. |
| At Cutoff (30 ng/mL): 31 Negative / 29 Positive. | ||
| At +25%, +50%, +75%, +100% of cutoff (37.5, 45, 52.5, 60 ng/mL): All 60 determinations were Positive. | ||
| Precision (Semi-Quantitative Mode) - Quantisal II Pad A | Mean concentrations should be close to expected values, with consistent negative/positive calls. | At -100% (0 ng/mL): Mean Conc. 0.5 ng/mL, 60 Negative. |
| At -75% (7.5 ng/mL): Mean Conc. 7.3 ng/mL, 60 Negative. | ||
| At -50% (15 ng/mL): Mean Conc. 14.7 ng/mL, 60 Negative. | ||
| At -25% (22.5 ng/mL): Mean Conc. 21.7 ng/mL, 60 Negative. | ||
| At Cutoff (30 ng/mL): Mean Conc. 29.9 ng/mL, 36 Negative / 24 Positive. | ||
| At +25% (37.5 ng/mL): Mean Conc. 42.4 ng/mL, 60 Positive. | ||
| At +50% (45 ng/mL): Mean Conc. 50.9 ng/mL, 60 Positive. | ||
| At +75% (52.5 ng/mL): Mean Conc. 57.3 ng/mL, 60 Positive. | ||
| At +100% (60 ng/mL): Mean Conc. 66.5 ng/mL, 60 Positive. | ||
| Precision (Qualitative Mode) - Quantisal II Pad B | Consistently identify negative samples below cutoff and positive samples above cutoff, with mixed results around cutoff. | At -100%, -75%, -50%, -25% of cutoff (0, 7.5, 15, 22.5 ng/mL): All 60 determinations were Negative. |
| At Cutoff (30 ng/mL): 28 Negative / 32 Positive. | ||
| At +25%, +50%, +75%, +100% of cutoff (37.5, 45, 52.5, 60 ng/mL): All 60 determinations were Positive. | ||
| Precision (Semi-Quantitative Mode) - Quantisal II Pad B | Mean concentrations should be close to expected values, with consistent negative/positive calls. | At -100% (0 ng/mL): Mean Conc. 0.3 ng/mL, 60 Negative. |
| At -75% (7.5 ng/mL): Mean Conc. 7.0 ng/mL, 60 Negative. | ||
| At -50% (15 ng/mL): Mean Conc. 14.9 ng/mL, 60 Negative. | ||
| At -25% (22.5 ng/mL): Mean Conc. 22.7 ng/mL, 60 Negative. | ||
| At Cutoff (30 ng/mL): Mean Conc. 30.8 ng/mL, 28 Negative / 32 Positive. | ||
| At +25% (37.5 ng/mL): Mean Conc. 42.9 ng/mL, 60 Positive. | ||
| At +50% (45 ng/mL): Mean Conc. 49.4 ng/mL, 60 Positive. | ||
| At +75% (52.5 ng/mL): Mean Conc. 58.3 ng/mL, 60 Positive. | ||
| At +100% (60 ng/mL): Mean Conc. 67.1 ng/mL, 60 Positive. | ||
| Specificity and Cross-Reactivity | Minimal or no cross-reactivity with structurally similar compounds at high concentrations, and significant cross-reactivity with known related compounds. | **No/Minimal Cross-Reactivity ( |
§ 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).