← Product Code [LCM](/productcode/LCM) · K152176

# Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176)

_Immunalysis Corporation · LCM · Sep 4, 2015 · TX · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K152176

## Device Facts

- **Applicant:** Immunalysis Corporation
- **Product Code:** [LCM](/productcode/LCM.md)
- **Decision Date:** Sep 4, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** TX
- **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.

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k152176

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

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**Source:** [https://fda-staging.innolitics.com/device/K152176](https://fda-staging.innolitics.com/device/K152176)

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