510(k) · Cleared
Recalled · Class II · 2012Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · DLZ Enzyme Immunoassay, Phenobarbital
Cleared on Jan 27, 2000 as substantially equivalent to K913190 (Syva Co., 1991) after a 140-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 27, 2000
- Review
- 140 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913190 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK913190 Emit (R) 2000 Phenobarbital Assay/CalibratorsSyva Co. · 1991 · Recalled
- This deviceK993031 Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and…Syva Co. · 2000
- Descendant · cites it directly · 0 of its ownK123271 Abbott Phenobarbital AssayMicrogenics Corp. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123271Abbott Phenobarbital AssayMicrogenics Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913190 | Emit (R) 2000 Phenobarbital Assay/Calibrators | Syva Co. | 1991 | 3 |
| 0 (this device) | K993031 | Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54 | Syva Co. | 2000 | — |
| +1 | K123271 | Abbott Phenobarbital Assay | Microgenics Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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 |
|---|---|---|---|
| * | K913190 | Emit (R) 2000 Phenobarbital Assay/CalibratorsSummary page 1…in human serum or plasma. The Abbott Aerose Phenobarbital Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Phenobarbital Assay (K913190) with regard to intended use, assay sample, and overall performance characteristics. tTM 28 510kabbtpheno.doc… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123271 | Abbott Phenobarbital Assay | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2012 | Class II | Z-1118-2013 | Nonconforming Material/Component | Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%… |
| Sep 26, 2006 | Not classified | Z-0454-2007 | Other | Erratic elevated results and or the inability to calibrate due to imprecision. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K123271 (Microgenics Corp., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DLZ devicesDLZ Enzyme Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the…
Read the full statement (137 words)
The Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the following reasons (1-3):
» Serum phenobarbital concentrations correlate better with concentration in the brain than does dosage once steady state is reached.
« Patients taking the same dosage of phenobarbital show considerable variation in serum phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens.
Methods historically used to monitor serum phenobarbital concentrations are gas-liquid chromatography, high-performance liquid chromatography, radlmmmunoassay, and immunoassay (1,2).
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/K993031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993031: Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993031
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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