510(k) · Cleared
Recalled · Class II · 2024Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator; Models K1167, KC212
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CIG Diazo Colorimetry, Bilirubin
Cleared on Aug 25, 2006 as substantially equivalent to K861700 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 67-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 25, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- CIG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861700 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK861700 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- This deviceK061719 Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK072717 Dimension Vista System Bilirubin Calibrator, Model KC210Dade Behring, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K072717Dimension Vista System Bilirubin Calibrator, Model KC210Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861700 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 2 |
| 0 (this device) | K061719 | Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil… | Dade Behring, Inc. | 2006 | — |
| +1 | K072717 | Dimension Vista System Bilirubin Calibrator, Model KC210 | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K861700 | Dimension (TM) Clinical Chemistry SystemSummary page 1…Bilirubin Calibrator Predicate Device: Dade Behring Dimension® TBIL Flex® reagent cartridge and TBIL/DBIL Calibrator (k861700) Device Description: TBIL Flex®& reagent cartridge Diazotized sulfanilic acid is formed by combining sodium nitrite a… | 1986 |
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 |
|---|---|---|---|
| K072717 | Dimension Vista System Bilirubin Calibrator, Model KC210 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2024 | Class II | Z-3065-2024 | Software Manufacturing/Software Deployment | During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA.… |
| Feb 13, 2020 | Class II | Z-1541-2020 | Under Investigation by firm | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension VistaTM System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.
The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061719 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061719: Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator; Models K1167, KC212.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061719
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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