510(k) · Cleared
ClearedRapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid Collector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biophor Diagnostics, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Apr 25, 2013 as substantially equivalent to K101746 (Microgenics Corp., 2011) after a 233-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 25, 2013
- Review
- 233 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000399 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000399 STC PCP Intercept Micro-Plate Eia, Model 11541OraSure Technologies, Inc. · 2000
- 1 generation backK101746 Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp. · 2011
- This deviceK122703 Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control…Biophor Diagnostics, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181135 Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK203489 SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541 | OraSure Technologies, Inc. | 2000 | — |
| −1 | K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay | Microgenics Corp. | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssaySummary page 1…1 862.3280 91 -Toxicology 807,921a)(3): Identification of Legallv Marketed Predicate Devices Thermo Scientific CEDIAO Phencyclidline (PCP) OFT Assay (k101746). 80792a)141: Device Descrin~tion The RapidFRET Oral Fluid Assay for PCP is an In Vitro Diagnostic competitive immunoiassay use… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | 2019 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181135 (Immunalysis Corporation, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Phencyclidine at 10 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific…
Read the full statement (182 words)
The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Phencyclidine at 10 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid PCP Calibrator Set and RapidFRET Oral Fluid PCP Control Set are intended for use only with the RapidFRET Oral Fluid Assay for PCP and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122703: Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid Collector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122703
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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