510(k) · Cleared

Cleared

Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX

K011057510(k) TraditionalCleared Jun 6, 200161-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

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

Cleared on Jun 6, 2001 as substantially equivalent to K970357 (Epitope, Inc., 1997) after a 61-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jun 6, 2001
Review: 61 days
Class: Class II
Product code: PJD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970357 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK970357 EpiscreenEpitope, Inc. · 1997
This deviceK011057 Intercept Oral Fluid Drug Test Oral Specimen Collection Device…OraSure Technologies, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970357	Episcreen	Epitope, Inc.	1997	—
0 (this device)	K011057	Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX	OraSure Technologies, Inc.	2001	—

FIG. 1 — Lineage of K011057, 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K970357	Episcreen Summary page 1 …ollection Device Classification Name: Blood Specimen Collection Device 3. Device to Which Substantial Equivalence Is Claimed: OraSure® Oral Specimen Collection Device; K970357 4. Description of Device: The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device consists of a treated absorbent…	Epitope, Inc.	1997	—
†	K001197	Cocaine Metabolite Intercept Micro-Plate Eia	OraSure Technologies, Inc.	2000	—
†	K000399	STC PCP Intercept Micro-Plate Eia, Model 11541	OraSure Technologies, Inc.	2000	—
†	K992918	STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I	OraSure Technologies, Inc.	2000	—
†	K002375	STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I	OraSure Technologies, Inc.	2001	4
†	K993208	STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I	OraSure Technologies, Inc.	2000	1
†	K981341	STC Opiates Micro-Plate Eia (Orasure Application)	OraSure Technologies, Inc.	1998	—
†	K001976	STC Barbiturates Intercept Micro-Plate Eia, Model 1108I	OraSure Technologies, Inc.	2000	1
†	K002010	STC Methadone Intercept Micro-Plate Eia, Model 11421	OraSure Technologies, Inc.	2000	—

Also cleared against K970357: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K970357.

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?

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE ElAs.

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/K011057 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011057: Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011057

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026