510(k) · Cleared
ClearedSalivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biochemical Diagnostics, Inc. · DIF Drug Mixture Control Materials
Cleared on Dec 16, 2013 as substantially equivalent to K103227 (Branan Medical Corporation, 2012) after a 110-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Dec 16, 2013
- Review
- 110 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924446 (1992). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 2 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 1 generation backK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- This deviceK132688 Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid…Biochemical Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK133047 Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −2 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −1 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| 0 (this device) | K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control… | Biochemical Diagnostics, Inc. | 2013 | — |
| +1 | K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators… | Biophor Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K103227 | Oratect Oral Fluid Drug Screen DevicesSummary page 2…quivalence Information: 1. Predicate device A Predicate K number Oratect®Check Saliva/Oral Fluid Controls K103227 (Positive and Negative) 6a. De vice Description: The Salivabuse ®9 multi-constituent and the Salivabuse®9 single… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral… | 2014 | 0 |
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 5.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K133047 (Biophor Diagnostics, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103227.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 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 Salivabuse® liquid oral fluid controls are intended for in vitro diagnostic use only as quality controls to monitor the precision of laboratory oral fluid toxicology testing procedures for the analytes listed in the package insert. The Salivabuse® controls are available as multi-constituent and single constituent controls.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132688: Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132688
Report an extraction error
Are you the manufacturer?
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