Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Device Facts
| Record ID | K152176 |
|---|---|
| Device Name | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
| Applicant | Immunalysis Corporation |
| Product Code | LCM · TX |
| Decision Date | Sep 4, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K152176 · Sep 4, 2015 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | Discarded clinical urine samples from clinical testing laboratories | Clinical urine samples were used to perform a method comparison study to verify the performance of the Immunalysis PCP Urine Enzyme Immunoassay against LC/MS confirmation. | Method comparison; Clinical urine samples; Discarded samples |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Method comparison study using clinical samples | Unaltered, anonymous and discarded clinical urine samples; Sample Size: 80 | LC/MS (Liquid Chromatography Tandem Mass Spectrometry) | Qualitative and semi-quantitative assay performance (agreement) |
Indications for Use
The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is calibrated against PCP. 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 permitting laboratories to establish quality control procedures. The Immunalysis PCP Urine Enzyme Immunoassay Kit 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 Liquid Chromatography/Mass Spectrometry (LC/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. The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.
Device Story
Device is a homogeneous enzyme immunoassay for PCP detection in human urine. Input: human urine samples. Principle: competitive binding between drug in sample and enzyme-labeled drug conjugate for recombinant PCP antibodies; enzyme activity (G6PDH) measured via clinical chemistry analyzer. Output: qualitative (positive/negative at 25ng/mL cutoff) or semi-quantitative results. Used in clinical laboratories by technicians/scientists. Output used by clinicians to identify potential drug presence, requiring confirmation by GC-MS or LC/MS. Benefits: rapid preliminary screening for PCP abuse.
Clinical Evidence
Bench testing only. Precision study (N=80) at ±25%, ±50%, ±75%, ±100% of cutoff. Specificity/cross-reactivity tested against structurally similar and non-similar compounds. Interference tested for endogenous compounds, pH, specific gravity, and boric acid. Linearity/recovery verified. Method comparison against LC/MS (N=80) showed 100% agreement for both qualitative and semi-quantitative modes.
Technological Characteristics
Homogeneous enzyme immunoassay. Reagents: recombinant PCP antibodies, G6P, NAD, and PCP-derivative labeled with G6PDH in Tris buffer with sodium azide. Calibrators: liquid, ready-to-use synthetic urine matrix. Analyzers: automated clinical chemistry (e.g., Beckman Coulter AU 400e). Storage: 2-8°C.
Indications for Use
Indicated for qualitative and semi-quantitative analysis of PCP in human urine. Intended for laboratory use with automated clinical chemistry analyzers. Prescription use only.
