510(k) · Cleared
ClearedImmulite Cocaine Metabolite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 8, 1997 as substantially equivalent to K870740 (Diagnostic Products Corp., 1987) after a 190-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Apr 8, 1997
- Review
- 190 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870740 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK870740 Coat-a-Count Cocaine Metabolite TKCN1 & TKCN5Diagnostic Products Corp. · 1987
- This deviceK963918 Immulite Cocaine MetaboliteDiagnostic Products Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870740 | Coat-a-Count Cocaine Metabolite TKCN1 & TKCN5 | Diagnostic Products Corp. | 1987 | — |
| 0 (this device) | K963918 | Immulite Cocaine Metabolite | Diagnostic Products Corp. | 1997 | — |
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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K870740 | Coat-a-Count Cocaine Metabolite TKCN1 & TKCN5Summary page 1…evice (862.32350), 91-DIO Diagnostic Products Corporation (DPC) 5700 West 96th Street Los Angeles, CA 90045-5597 2017183 DPC('s Coat-A-Count (CAC) Cocaine Metabolite (K870740) Description and Intended Use of Device: IMMULITE® Cocaine Metabolite 1s a solid-phase. chemiluminescent enzyme immunoassay des… | 1987 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A reagent system designed for the semi-quantitative analysis of benzoylecgonine, and its parent compound, cocaine, in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for cocaine and its principal metabolites.
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/K963918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963918: Immulite Cocaine Metabolite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963918
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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