510(k) · Cleared
ClearedOnline Phenobarbital, Model 03016757190 & 03510620
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DLZ Enzyme Immunoassay, Phenobarbital
Cleared on Sep 12, 2007 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) after an 89-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 12, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951595 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- This deviceK071644 Online Phenobarbital, Model 03016757190 & 03510620Roche Diagnostics Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| 0 (this device) | K071644 | Online Phenobarbital, Model 03016757190 & 03510620 | Roche Diagnostics Corp. | 2007 | — |
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 |
|---|---|---|---|
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 1…ation name: Enzyme Immunoassay, Phenobarbital 3) Predicate We claim substantial equivalence to the currently marketed COBAS device INTEGRA Phenobarbital (K951595). 4) Device The ONLINE TDM Phenobarbital assay is for the quantitative determination Description of phenobarbital i… | 1995 |
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?
- Its one ancestor has a recall.
- 31 other devices also cite its predicate K951595.
How does its category compare?
All DLZ devicesDLZ Enzyme Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071644 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071644: Online Phenobarbital, Model 03016757190 & 03510620.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071644
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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