510(k) · Cleared
ClearedAlinity c Tricyclic Antidepressants Reagent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
Cleared on Nov 17, 2023 as substantially equivalent to K213875 (Microgenics Corporation, 2022) after a 221-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Nov 17, 2023
- Review
- 221 days
- Class
- Class II
- Product code
- LFH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983268 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LFH? 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 LFH device
- #1 K213875 DRI TM Tricyclics Serum Tox Assayscore 7.5 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K213875 | DRI TM Tricyclics Serum Tox AssaySummary page 5…DeviceManufacturer: Microgenics Corporation Predicate Device Common Tricyclics Serum Tox Assay Name Predicate Device Premarket K213875 Notification #: Predicate Device Product LFH, Class II, Code, Classification, 21 CFR 862… | 2022 |
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 25 years and passes through 2 companies; a new generation was cleared every 24.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LFH devicesLFH U.V. Spectrometry, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LFH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFH
Too few LFH 510(k)s in any year since 2007 to give a median.
Recalls per year · LFH
No recall names LFH since 2007.
Adverse event reports per year · LFH
1in 2007
MAUDE reports naming product code LFH, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alinity ¢ Tricyclic Antidepressants Reagent Kit is a homogeneous enzyme immunoassay intended for use in the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum or plasma at a cutoff concentration of 300 ng/mL on the Alinity c system in patients suspected of drug overdose. The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the…
Read the full statement (150 words)
The Alinity ¢ Tricyclic Antidepressants Reagent Kit is a homogeneous enzyme immunoassay intended for use in the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum or plasma at a cutoff concentration of 300 ng/mL on the Alinity c system in patients suspected of drug overdose.
The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS), or for permitting laboratories to establish control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
For In Vitro Diagnostic Use Only.
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/K231020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231020: Alinity c Tricyclic Antidepressants Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231020
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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