510(k) Report

510(k) · Cleared

Cleared

Quantisal™ II Oral Fluid Collection Device

K223781510(k) TraditionalCleared Jul 28, 2023224-day reviewClass II21 CFR 862.1675

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Immunalysis Corporation · PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Cleared on Jul 28, 2023 as substantially equivalent to K183048 (Immunalysis Corporation, 2019) after a 224-day review. Its family tree reaches back 2 generations to 1995.

Decided
Jul 28, 2023
Review
224 days
Class
Class II
Product code
PJD
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K942435 (1995). No later device cites it as a predicate yet.

K942435 · Saliva Sampler · Saliva Diagnostic Systems, Inc. · 1995K183048 · Quantisal II Oral Fluid Collection Device · Immunalysis Corporation · 20191995200020052010201520202025
K183048 · Quantisal II Oral Fluid Collection Device · Immunalysis Corporation · 2019K942435 · Saliva Sampler · Saliva Diagnostic Systems, Inc. · 19950
  1. Root · 2 generations backK942435 Saliva SamplerSaliva Diagnostic Systems, Inc. · 1995
  2. 1 generation backK183048 Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 2019
  3. This deviceK223781 Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K942435Saliva SamplerSaliva Diagnostic Systems, Inc.1995—
−1K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation2019—
0 (this device)K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation2023—
FIG. 1 — Lineage of K223781, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232898 Quantisal™ Oral Fluid Collection Devicescore 7.0 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K183048Quantisal II Oral Fluid Collection Device
Summary page 5
…Clinical Chemistry Predicate Information Company: Immunalysis Corporation Device: Quantisal II Oral Fluid Collection Device (K183048) 5.2 Device Description The Quantisal II Oral Fluid Collection Device is intended for the collection, preservatio…
Immunalysis Corporation2019—

Also cleared against K183048: 1 other device →

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 23.9 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K183048.

How does its category compare?

All PJD devices

PJD 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

2019: 12020: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

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

2016: 12017: 12019: 12020: 32022: 12023: 22024: 12025: 1
2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code PJD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—01
20180—00
20191—01
20201—03
20210—00
20220—01
20232—02
20240—01
20250—01
20260—0—

What is it indicated for?

The Quantisal™ II 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.

Also cleared against K183048

1 other device cites the same predicate.

  • K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020

More from Immunalysis Corporation

50 FDA decisions under this applicant name. See the company

  • K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
  • K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  • K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021

Recent decisions in PJD

The PJD category page

  • K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  • K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020
  • K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 2019
  • K011057Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXOraSure Technologies, Inc. · 2001
  • K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 19991 recall

https://510kreport.com/device/K223781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223781: Quantisal™ II Oral Fluid Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223781

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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