510(k) · Cleared
Recalled · Class II · 2013Vitros Chemistry Products PHBR Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DLZ Enzyme Immunoassay, Phenobarbital
Cleared on Jan 26, 1999 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 26, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- 3
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK984288 Vitros Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK042476 Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK043384 Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK043386 Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK042479 Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
- Descendant · cites it directly · 0 of its ownK042520 Vitros Chemistry Products Caffn Reagent Kit and TDM Performance…Ortho-Clinical Diagnostics, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K042476Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly3descendants
- K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
- K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
- K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
- K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984288 | Vitros Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| +1 | K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| +2 | K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +2 | K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | 3 |
| +2 | K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr… | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
| +1 | K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2013 | Class II | Z-0319-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| Mar 14, 2013 | Class II | Z-1152-2013 | Unknown/Undetermined by firm | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's… |
| Jun 23, 2011 | Not classified | Z-1117-2012 | Nonconforming Material/Component | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042476 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 3 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?
For in vitro diagnostic use only.
VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984288 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984288: Vitros Chemistry Products PHBR Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984288
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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