510(k) · Cleared

Cleared

Modification of Emit D.a.U. Opiates Assay

K984232510(k) TraditionalCleared Jan 22, 199958-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 Jan 22, 1999 as substantially equivalent to K971596 (Behring Diagnostics, Inc., 1997) after a 58-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jan 22, 1999
Review: 58 days
Class: Class II
Product code: DJG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K902577 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK902577 Emit (R) II Opiate AssaySyva Co. · 1990
1 generation backK971596 Emit II Opiates 300/2000 AssayBehring Diagnostics, Inc. · 1997
This deviceK984232 Modification of Emit D.a.U. Opiates AssaySyva Co. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K902577	Emit (R) II Opiate Assay	Syva Co.	1990	—
−1	K971596	Emit II Opiates 300/2000 Assay	Behring Diagnostics, Inc.	1997	—
0 (this device)	K984232	Modification of Emit D.a.U. Opiates Assay	Syva Co.	1999	—

FIG. 1 — Lineage of K984232, 1990–1999Source: 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 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
#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
*	K971596	Emit II Opiates 300/2000 Assay Summary page 1 …with a 300 ng/mL or 2000 ng/mL cutoff. The modified Emit® d.a.u.™ Opiates Assay has been found to be equivalent to the predicate device: Emit® I Opiates 300/2000 Assay (K971596) with regard to intended use, assay sample, and overall performance characteristics. Comparative Analysis: The modified Emit® d.…	Behring Diagnostics, Inc.	1997	—

Also cleared against K971596: 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 9 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K971596.

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	—

What is it indicated for?

Emit® d.a.u.™ Opiates Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative or semiquantitative analysis of opiates in human urine. The assay is used to screen for potential drugs of abuse.

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/K984232 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984232: Modification of Emit D.a.U. Opiates Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984232

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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