510(k) · Cleared

Cleared

Episcreen

K970357510(k) TraditionalCleared Mar 10, 199739-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

Epitope, Inc. · PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Cleared on Mar 10, 1997 after a 39-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.

Decided: Mar 10, 1997
Review: 39 days
Class: Class II
Product code: PJD
Recalls: None
Predicates: 0

4 later devices descend from it, 3 citing it directly.

This deviceK970357 EpiscreenEpitope, Inc. · 1997
Descendant · cites it directly · 2 of its ownK973395 Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 1998
Descendant · cites it directly · 1 of its ownK984361 Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999 · Recalled
Descendant · cites it directly · 0 of its ownK011057 Intercept Oral Fluid Drug Test Oral Specimen Collection Device…OraSure Technologies, Inc. · 2001
Descendant · 2 generations on · 0 of its ownK991800 Hemochek Urine Collection KitOsborn Group, Inc. · 1999

Most influential descendants

Showing 4 of 4 · See all

K973395Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 1998 · cites it directly2descendants
K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999 · cites it directly1descendant
K011057Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXOraSure Technologies, Inc. · 2001 · cites it directly0descendants
K991800Hemochek Urine Collection KitOsborn Group, Inc. · 1999 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970357	Episcreen	Epitope, Inc.	1997	—
+1	K973395	Episcreen Oral Specimen Collection Device	Epitope, Inc.	1998	—
+1	K984361	Oral-Eze Oral Fluid Collection System	Osborn Laboratories, Inc.	1999	1
+1	K011057	Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX	OraSure Technologies, Inc.	2001	—
+2	K991800	Hemochek Urine Collection Kit	Osborn Group, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2001	1	0

FIG. 1 — Lineage of K970357, 1997–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Recalls
*	—	Saliva Sampler Named without a submission number	—
*	—	Salivette Named without a submission number	—
*	—	Saliva Sac Named without a submission number	—

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K973395	Episcreen Oral Specimen Collection Device	Epitope, Inc.	1998	2
K984361	Oral-Eze Oral Fluid Collection System	Osborn Laboratories, Inc.	1999	1
K011057	Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX	OraSure Technologies, Inc.	2001	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?

Of its descendants, K973395 (Epitope, Inc., 1998) has gone furthest, with 2 descendants of its own.

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.

FDA decisions per year · PJD

2in 2023

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	1
2017	0	—	1
2018	0	—	0
2019	1	—	1
2020	1	—	3
2021	0	—	0
2022	0	—	1
2023	2	—	2
2024	0	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

EpiScreen is intended for.use.in the collection, preservation, and 'ransport -

of oral fluid specimens’

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/K970357 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970357: Episcreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970357

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