510(k) · Cleared
ClearedAbbott Phenobarbital Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DLZ Enzyme Immunoassay, Phenobarbital
Cleared on Apr 26, 2013 as substantially equivalent to K993031 (Syva Co., 2000) after a 189-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Apr 26, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913190 (1991). 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 DLZ? 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 DLZ device
- #1 K210858 VITROS Chemistry Products PHBR Slidesscore 2.1 · 2 generations · 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 |
|---|---|---|---|
| * | K993031 | Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54Summary page 3…cate Proprietary Abbott Phenobarbital Assay Abbott Aeroset" Phenobarbital Assay Name (k993031) Intended Use The Phenobarbital assay is used for the in The assay is intended for use in the vitro quan… | 2000 |
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 22 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All DLZ devicesDLZ Enzyme Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DLZ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DLZ
Too few DLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLZ
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLZ
1in 2024
MAUDE reports naming product code DLZ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 58 |
| 2012 | 0 | — | 2 | 222 |
| 2013 | 1 | — | 2 | 101 |
| 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123271: Abbott Phenobarbital Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123271
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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