510(k) · Cleared
Recalled · Class II · 2014Vitros Chemistry Products CRBM Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · KLT Enzyme Immunoassay, Carbamazepine
Cleared on Feb 25, 1998 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 3 times.
- Decided
- Feb 25, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- KLT
- Recalls
- 3
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 KLT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Mar 5, 2014 | Class II | Z-1470-2014 | Release of Material/Component prior to receiving test results | The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. |
| Jun 12, 2013 | Class II | Z-0307-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and… |
| May 26, 2005 | Not classified | Z-1016-05 | Other | Falsely elevated Carbamazepine results. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KLT devicesKLT Enzyme Immunoassay, Carbamazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KLT
Too few KLT 510(k)s in any year since 2007 to give a median.
Recalls per year · KLT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLT
4in 2025
MAUDE reports naming product code KLT, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only.
VITROS CRBM slides quantitatively measure carbamazepine (CRBM) 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/K980283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980283: Vitros Chemistry Products CRBM Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980283
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026