510(k) · Cleared

Cleared

Abuscreen (R) Online (TM) for THC (50/100)(100TEST KT

K913414510(k) TraditionalCleared Sep 25, 199162-day reviewClass II21 CFR 862.3870

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

Roche Diagnostic Systems, Inc. · LAT Radioimmunoassay, Cannabinoid (S)

Cleared on Sep 25, 1991 after a 62-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Sep 25, 1991
Review: 62 days
Class: Class II
Product code: LAT
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK913414 Abuscreen (R) Online (TM) for THC (50/100)(100TEST KTRoche Diagnostic Systems, Inc. · 1991
Descendant · cites it directly · 0 of its ownK981584 Abuscreen Online for Cannabinoids (100 Test Kit)Roche Diagnostic Systems, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all

K981584Abuscreen Online for Cannabinoids (100 Test Kit)Roche Diagnostic Systems, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913414	Abuscreen (R) Online (TM) for THC (50/100)(100TEST KT	Roche Diagnostic Systems, Inc.	1991	—
+1	K981584	Abuscreen Online for Cannabinoids (100 Test Kit)	Roche Diagnostic Systems, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K913414, 1991–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LAT? 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K981584	Abuscreen Online for Cannabinoids (100 Test Kit)	Roche Diagnostic Systems, Inc.	1998	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, K981584 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LAT devices

LAT Radioimmunoassay, Cannabinoid (S): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAT

FDA has decided no LAT device since 2007.

Median 510(k) review, days · LAT

Too few LAT 510(k)s in any year since 2007 to give a median.

Recalls per year · LAT

No recall names LAT since 2007.

Adverse event reports per year · LAT

No MAUDE report names LAT since 2007.

View these four charts as a table

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

https://510kreport.com/device/K913414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913414: Abuscreen (R) Online (TM) for THC (50/100)(100TEST KT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913414

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026