510(k) · Cleared
Recalled · Class II · 2013Emit 2000 Phenobarbital Assay, Model OSR4D229
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 Jun 6, 2001 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Jun 6, 2001
- Review
- 20 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- 3
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2013 | Class II | Z-0181-2014 | Nonconforming Material/Component | Imprecision with certain lots |
| Dec 10, 2012 | Class II | Z-0664-2013 | Nonconforming Material/Component | Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be… |
| Jul 30, 2012 | Class II | Z-0030-2013 | Nonconforming Material/Component | Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the… |
No ancestor or descendant has a Class I recall.
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 | — |
https://510kreport.com/device/K011528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011528: Emit 2000 Phenobarbital Assay, Model OSR4D229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011528
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026