510(k) · Cleared
ClearedSTC PCP Intercept Micro-Plate Eia, Model 11541
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OraSure Technologies, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on May 15, 2000 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 15, 2000
- Review
- 98 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK000399 STC PCP Intercept Micro-Plate Eia, Model 11541OraSure Technologies, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- Descendant · 2 generations on · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK101746 Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp. · 2011
- Descendant · 2 generations on · 2 of its ownK122703 Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control…Biophor Diagnostics, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK181135 Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012 · cites it directly6descendants
- K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · 2 generations on3descendants
- K101746Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp. · 2011 · cites it directly3descendants
- K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…Biophor Diagnostics, Inc. · 2013 · 2 generations on2descendants
- K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541 | OraSure Technologies, Inc. | 2000 | — |
| +1 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| +2 | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +1 | 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 | — |
| +3 | K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K103227 (Branan Medical Corporation, 2012) has gone furthest, with 6 descendants 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.
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 | — |
https://510kreport.com/device/K000399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000399: STC PCP Intercept Micro-Plate Eia, Model 11541.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000399
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026