← Product Code [LCM](/productcode/LCM) · K203489

# SEFRIA PCP Oral Fluid Enzyme Immunoassay (K203489)

_Immunalysis Corporation · LCM · Apr 20, 2021 · TX · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K203489

## Device Facts

- **Applicant:** Immunalysis Corporation
- **Product Code:** [LCM](/productcode/LCM.md)
- **Decision Date:** Apr 20, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** TX

## Indications for Use

For In Vitro Diagnostic Use. The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of PCP in human oral fluid with clinical analyzers. This assay is calibrated against PCP. 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 PCP Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method 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.

## Device Story

Homogeneous enzyme immunoassay for PCP detection in human oral fluid; utilizes Quantisal/Quantisal II collection devices. Samples processed on automated clinical chemistry analyzers (e.g., Beckman Coulter AU480). Assay provides qualitative (positive/negative) or semi-quantitative results based on 10 ng/mL cutoff. Used in clinical laboratories to screen for PCP; preliminary positive results require confirmatory testing via GC-MS or LC-MS/MS. Semi-quantitative mode assists in determining specimen dilution for confirmation or establishing quality control. Clinical decision-making relies on professional judgment following preliminary results; benefits include rapid screening for drug abuse.

## Clinical Evidence

Bench testing only. Precision study (N=60 per concentration) confirmed repeatability across 15 days. Linearity/recovery study confirmed range of 4-40 ng/mL. Method comparison study using 80 clinical samples analyzed on Beckman Coulter AU480 vs. LC-MS/MS showed 100% agreement for both qualitative and semi-quantitative modes.

## Technological Characteristics

Homogeneous enzyme immunoassay; utilizes antibody reagent and drug conjugate reagent. Calibrated against PCP. Compatible with automated clinical chemistry analyzers. Storage at 2-8°C. Linear range 4-40 ng/mL. Cutoff 10 ng/mL.

## Submission Summary (Full Text)

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

510(k) Number: k203489

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/K203489](https://fda-staging.innolitics.com/device/K203489)

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