510(k) · Cleared
ClearedCocaine Metabolite Intercept Micro-Plate Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OraSure Technologies, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on May 11, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 11, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK001197 Cocaine Metabolite Intercept Micro-Plate EiaOraSure Technologies, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- Descendant · 2 generations on · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK050945 Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays…Lin-Zhi International, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK181305 OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK132688 Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid…Biochemical Diagnostics, Inc. · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012 · cites it directly6descendants
- K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · 2 generations on3descendants
- K050945Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & ControlsLin-Zhi International, Inc. · 2006 · cites it directly2descendants
- K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018 · 3 generations on1descendant
- K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001197 | Cocaine Metabolite Intercept Micro-Plate Eia | OraSure Technologies, Inc. | 2000 | — |
| +1 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| +2 | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +1 | K050945 | Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators &… | Lin-Zhi International, Inc. | 2006 | — |
| +3 | K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +2 | K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control… | Biochemical Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 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 3.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K103227 (Branan Medical Corporation, 2012) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K001197 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001197: Cocaine Metabolite Intercept Micro-Plate Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001197
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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