510(k) · Cleared
ClearedRapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biophor Diagnostics, Inc. · LAF Gas Chromatography, Methamphetamine
Cleared on Sep 18, 2015 as substantially equivalent to K131652 (Lin-Zhi International, Inc., 2014) after a 396-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Sep 18, 2015
- Review
- 396 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924446 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 4 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 3 generations backK050988 Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and…Lin-Zhi International, Inc. · 2006
- 2 generations backK062242 Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay…Lin-Zhi International, Inc. · 2006
- 1 generation backK131652 Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2014
- This deviceK142293 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −4 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −3 | K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls | Lin-Zhi International, Inc. | 2006 | — |
| −2 | K062242 | Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and… | Lin-Zhi International, Inc. | 2006 | — |
| −1 | K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls | Lin-Zhi International, Inc. | 2014 | — |
| 0 (this device) | K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid… | Biophor Diagnostics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsSummary page 4…0 91 - Toxicology 807.92(a)(3): Identification of Legally Marketed Predicate Devices Lin-Zhi International, Inc., LZI Oral Fluid Methamphetamine Enzyme Immunoassay (k131652). 807.92(a)(4): Device Description The RapidFRET Oral Fluid Assay for Methamphetamine is an In Vitro Diagnostic competitive imm… | 2014 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K131652.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 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 Methamphetamine is a homogencous 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 methamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To oblain a confirmed analytical result. a…
Read the full statement (179 words)
The RapidFRET Oral Fluid Assay for Methamphetamine is a homogencous 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 methamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To oblain 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 Lest result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Methamphetamine Calibrators and RapidFRET Oral Fluid Methamphetamine Controls are intended for use only with appropriatc RapidFRET Oral Fluid Assay products and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutofT 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142293: Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142293
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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