510(k) · Cleared

Cleared

Emit (R) II Opiate Assay

K902577510(k) TraditionalCleared Jul 27, 199046-day reviewClass II21 CFR 862.3650

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

Syva Co. · DJG Enzyme Immunoassay, Opiates

Cleared on Jul 27, 1990 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Jul 27, 1990
Review: 46 days
Class: Class II
Product code: DJG
Recalls: None
Predicates: 0

3 later devices descend from it, 1 citing it directly.

This deviceK902577 Emit (R) II Opiate AssaySyva Co. · 1990
Descendant · cites it directly · 2 of its ownK971596 Emit II Opiates 300/2000 AssayBehring Diagnostics, Inc. · 1997
Descendant · 2 generations on · 0 of its ownK013314 OpiatesAbbott Laboratories · 2002
Descendant · 2 generations on · 0 of its ownK984232 Modification of Emit D.a.U. Opiates AssaySyva Co. · 1999

Most influential descendants

Showing 3 of 3 · See all

K971596Emit II Opiates 300/2000 AssayBehring Diagnostics, Inc. · 1997 · cites it directly2descendants
K013314OpiatesAbbott Laboratories · 2002 · 2 generations on0descendants
K984232Modification of Emit D.a.U. Opiates AssaySyva Co. · 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)	K902577	Emit (R) II Opiate Assay	Syva Co.	1990	—
+1	K971596	Emit II Opiates 300/2000 Assay	Behring Diagnostics, Inc.	1997	—
+2	K013314	Opiates	Abbott Laboratories	2002	—
+2	K984232	Modification of Emit D.a.U. Opiates Assay	Syva Co.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	1	0

FIG. 1 — Lineage of K902577, 1990–2002Source: 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 DJG? 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 DJG device

#1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K971596	Emit II Opiates 300/2000 Assay	Behring Diagnostics, Inc.	1997	2

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, K971596 (Behring Diagnostics, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DJG devices

DJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DJG

3in 2025

2007high 12 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJG

31in 2025

2007high 422 (2021) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DJG

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DJG

1in 2025

2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJG, 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	2	—	0	0
2008	2	—	0	0
2009	2	—	0	0
2010	6	187	0	0
2011	6	233	1	4
2012	5	95	0	1
2013	5	60	0	4
2014	9	62	0	0
2015	12	141	0	3
2016	2	—	0	2
2017	4	101	0	1
2018	5	134	0	1
2019	3	235	1	0
2020	5	30	0	0
2021	3	422	0	2
2022	2	—	0	1
2023	10	140	0	0
2024	5	150	0	3
2025	3	31	2	1
2026	3	157	0	—

https://510kreport.com/device/K902577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902577: Emit (R) II Opiate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902577

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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