FDA product code · Clinical Toxicology
DJGEnzyme Immunoassay, Opiates
Product code DJG covers Enzyme Immunoassay, Opiates, a Class II device regulated under 21 CFR 862.3650. FDA has cleared 215 devices in this code, 5 of them in the last 12 months. Median review time across the 215 most recent decisions is 88 days. openFDA lists 13 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.3650
- Review panel
- Clinical Toxicology
- Clearances
- 215
What is happening in DJG right now?
DJG (Enzyme Immunoassay, Opiates) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0733-2026, Z-0734-2026). The code is crowded, scoring 63 of 100 — 80 companies hold a clearance here and 5 arrived in the last 12 months (DJG:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0733-2026, Z-0734-2026 |
| Crowding | Context | DJG:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in DJG?
FDA has cleared 215 devices under product code DJG since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | |
| K252520 | SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation | |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. |
How long does FDA review take for DJG?
The median FDA review time for DJG is 88 days, measured across the 215 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DJG?
openFDA lists 13 recall records against product code DJG. A recall record covers one firm's corrective action and may span many device lots.
Z-0733-2026Open, ClassifiedGET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Z-0734-2026Open, ClassifiedGET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Z-2073-2025Open, ClassifiedOrtho-Clinical Diagnostics, Inc.
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
Z-1743-2020TerminatedCarolina Liquid Chemistries
Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes
Z-1751-2020TerminatedBeckman Coulter, Inc.
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
Showing the 5 most recently initiated of 13. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DJG?
MAUDE holds 4 adverse-event reports naming product code DJG, 1 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DJG unusual?
DJG does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
3 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in DJG?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DJG?
Across the 215 most recent decisions, these applicants filed most often in DJG.
| Applicant | Recent clearances |
|---|---|
| Lin-Zhi International, Inc. | 16 |
| Immunalysis Corporation | 11 |
| Guangzhou Wondfo Biotech Co., Ltd. | 8 |
| Syva Co. | 8 |
| Medtox Diagnostics, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in DJG files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Microgenics Corporation | 13 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DJG
Get an email the morning anything changes in DJG — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.