510(k) · Cleared
ClearedLabone Micro-Plate Cotinine Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Labone, Inc. · DLJ Calibrators, Drug Specific
Cleared on Feb 10, 2004 as substantially equivalent to K974234 (OraSure Technologies, Inc., 1998) after an 88-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Feb 10, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974234 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974234 Micro-Plate Cotinine EiaOraSure Technologies, Inc. · 1998
- This deviceK033601 Labone Micro-Plate Cotinine EiaLabone, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026
Most influential descendants
Showing 2 of 2 · See all- K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC · 2023 · cites it directly1descendant
- K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974234 | Micro-Plate Cotinine Eia | OraSure Technologies, Inc. | 1998 | — |
| 0 (this device) | K033601 | Labone Micro-Plate Cotinine Eia | Labone, Inc. | 2004 | — |
| +1 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… | Healgen Scientific,, LLC | 2023 | — |
| +2 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid… | Healgen Scientific,, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 DLJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K974234 | Micro-Plate Cotinine EiaSummary page 1…r: 862.3220 Substantially Equivalent Device: Product: OraSure Micro-Plate Cotinine EIA Manufactured by: OraSure® Technologies, Inc. 510(k) Number: K974234 Intended Use and Product Description: LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay fo… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | 2023 | 1 |
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.
- Of its descendants, K223162 (Healgen Scientific,, LLC, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only. The LabOne Microplate Cotinine Calibrators are a…
Read the full statement (128 words)
LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only.
The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva.
The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033601: Labone Micro-Plate Cotinine Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033601
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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