510(k) · Cleared
ClearedArchitect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DLZ Enzyme Immunoassay, Phenobarbital
Cleared on Sep 26, 2008 as substantially equivalent to K940596 (Abbott Laboratories, 1994) after a 148-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Sep 26, 2008
- Review
- 148 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940596 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK940596 Axsym PhenobarbitalAbbott Laboratories · 1994
- This deviceK081231 Architect Iphenobarbital Reagents and Architect Iphenobarbital…Abbott Laboratories · 2008
- Descendant · cites it directly · 0 of its ownK210858 VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940596 | Axsym Phenobarbital | Abbott Laboratories | 1994 | — |
| 0 (this device) | K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators… | Abbott Laboratories | 2008 | — |
| +1 | K210858 | VITROS Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K940596 | Axsym PhenobarbitalSummary page 2…ITECT iPhenobarbital Page 1 of 3 510(k) Submission Legally marketed device to which equivalency is claimed: AxSYM Phenobarbital (K940596) Intended Use of Device: The ARCHITECT i Phenobarbital assay'is an in vitro chemiluminescent microparticle immunoass… | 1994 |
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 |
|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR Slides | 2021 | 0 |
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 no recall.
- Of its descendants, K210858 (Ortho-Clinical Diagnostics, Inc., 2021) 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. 2008, 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 ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STATprotocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
The ARCHITECT iPhenobarbital Calibrators are for the calibration of the ARCHITECT i System with STA T protocol capability when used for the quantitative determination of phenobarbital in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081231: Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081231
Report an extraction error
Are you the manufacturer?
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