510(k) · Cleared

Cleared

Status DS Oxy

K130650510(k) TraditionalCleared Feb 26, 2014352-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

Princeton BioMeditech Corp. · DJG Enzyme Immunoassay, Opiates

Cleared on Feb 26, 2014 as substantially equivalent to K060351 (Medtox Diagnostics, Inc., 2006) after a 352-day review. Its family tree reaches back 3 generations to 2002.

Decided: Feb 26, 2014
Review: 352 days
Class: Class II
Product code: DJG
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K014101 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
2 generations backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
1 generation backK060351 Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
This deviceK130650 Status DS OxyPrinceton BioMeditech Corp. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K014101	Rapidone-Oxy Test	American Bio Medica Corp.	2002	—
−2	K040411	Dri Oxycodone Assay	Microgenics Corp.	2004	—
−1	K060351	Medtox Oxycodone	Medtox Diagnostics, Inc.	2006	—
0 (this device)	K130650	Status DS Oxy	Princeton BioMeditech Corp.	2014	—

FIG. 1 — Lineage of K130650, 2002–2014Source: 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
*	K060351	Medtox Oxycodone Summary page 1 …11 4.3. Product Code: DJG 4.4. Panel: Toxicology (91) 5. Identification of legally marketed devices to which claims of equivalence are made: K06035 1: MedTox Oxycodone by MedTox Diagnostics 6. Device Description: The Status DSTM OXY test device is a simple immuno-…	Medtox Diagnostics, Inc.	2006	—

Also cleared against K060351: 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 12 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K060351.

How does its category compare?

All DJG devices

DJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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?

The Status DSTM OXY is an immunocbromnatograhic test for the qualitative detection of Oxycodone in urine samples. The detection cut-off concentration of Oxycodone is 100 ng/mL. The test may be read visually or by using a DXpressm Reader. It is intended for clinical laboratory use only.

This assay provides only a preliminary analytical test result A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to the test reslt, particularly when preliminary positive results are obtained.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130650 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130650: Status DS Oxy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130650

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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