510(k) · Cleared
ClearedSEFRIA PCP Oral Fluid Enzyme Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Apr 20, 2021 as substantially equivalent to K181135 (Immunalysis Corporation, 2019) after a 144-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Apr 20, 2021
- Review
- 144 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000399 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK000399 STC PCP Intercept Micro-Plate Eia, Model 11541OraSure Technologies, Inc. · 2000
- 3 generations backK101746 Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp. · 2011
- 2 generations backK122703 Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control…Biophor Diagnostics, Inc. · 2013
- 1 generation backK181135 Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019
- This deviceK203489 SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541 | OraSure Technologies, Inc. | 2000 | — |
| −3 | K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay | Microgenics Corp. | 2011 | — |
| −2 | K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and… | Biophor Diagnostics, Inc. | 2013 | — |
| −1 | K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2019 | — |
| 0 (this device) | K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCM device
- #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassaySummary page 4…assification Regulation: Unclassified Panel: Toxicology (91) Predicate Device: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay [K181135] 1… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LCM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LCM
Too few LCM 510(k)s in any year since 2007 to give a median.
Recalls per year · LCM
No recall names LCM since 2007.
Adverse event reports per year · LCM
2in 2019
MAUDE reports naming product code LCM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For In Vitro Diagnostic Use. The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an 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…
Read the full statement (172 words)
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203489: SEFRIA PCP Oral Fluid Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203489
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026