510(k) · Cleared
ClearedRapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biophor Diagnostics, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 20, 2015 as substantially equivalent to K110446 (Roche Diagnostics, 2011) after a 324-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- May 20, 2015
- Review
- 324 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933052 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- 2 generations backK992918 STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 2000
- 1 generation backK110446 Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche…Roche Diagnostics · 2011
- This deviceK141748 Rapidfret Oral Fluid Assay for Amphetamine, 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 |
|---|---|---|---|---|---|
| −3 | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| −2 | K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I | OraSure Technologies, Inc. | 2000 | — |
| −1 | K110446 | Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral… | Roche Diagnostics | 2011 | — |
| 0 (this device) | K141748 | Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine… | Biophor Diagnostics, Inc. | 2015 | — |
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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 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 |
|---|---|---|---|
| * | K110446 | Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat…Summary page 4…Amphetamine Control Set Reserved 807.92(a)(3): Identification of Legally Marketed Predicate Devices Roche Diagnostics DAT Oral Fluid Amphetamine (k110446). 807.92(a)(4): Device Description The RapidFRET Oral Fluid Assay for Amphetamine is an In Vitro Diagnostic competitive immunoa… | 2011 |
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 22 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RapidFRET Oral Fluid Assay for Amphetamine 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 amphetamine at 50 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…
Read the full statement (182 words)
The RapidFRET Oral Fluid Assay for Amphetamine 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 amphetamine at 50 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 Amphetamine Calibrator Set and RapidFRET Oral Fluid Amphetamine Control Set are intended for use only with the RapidFRET Oral Fluid Assay for Amphetamine 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/K141748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141748: Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141748
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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