510(k) · Cleared
ClearedQuantisal™ Oral Fluid Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Cleared on Nov 21, 2023 as substantially equivalent to K200801 (Immunalysis Corporation, 2020) after a 64-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Nov 21, 2023
- Review
- 64 days
- Class
- Class II
- Product code
- PJD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942435 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK942435 Saliva SamplerSaliva Diagnostic Systems, Inc. · 1995
- 2 generations backK183048 Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 2019
- 1 generation backK200801 Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020
- This deviceK232898 Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942435 | Saliva Sampler | Saliva Diagnostic Systems, Inc. | 1995 | — |
| −2 | K183048 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | 2019 | — |
| −1 | K200801 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | 2020 | — |
| 0 (this device) | K232898 | Quantisal™ Oral Fluid Collection Device | Immunalysis Corporation | 2023 | — |
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 PJD? 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 PJD device
- #1 K223781 Quantisal™ II Oral Fluid Collection Devicescore 6.0 · 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 |
|---|---|---|---|
| * | K200801 | Quantisal Oral Fluid Collection DeviceSummary page 5…el: Clinical Chemistry Predicate Information Company: Immunalysis Corporation Device: Quantisal™ Oral Fluid Collection Device (K200801) 5.2 Device Description The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and tr… | 2020 |
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 28 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All PJD devicesPJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PJD
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PJD
Too few PJD 510(k)s in any year since 2007 to give a median.
Recalls per year · PJD
No recall names PJD since 2007.
Adverse event reports per year · PJD
1in 2025
MAUDE reports naming product code PJD, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232898: Quantisal™ Oral Fluid Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232898
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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