510(k) Report

510(k) · Cleared

Cleared

Dimension Vista Dbil Flex Reagent Cartridge, Model K2125

K061839510(k) TraditionalCleared Aug 29, 200661-day reviewClass II21 CFR 862.1110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · CIG Diazo Colorimetry, Bilirubin

Cleared on Aug 29, 2006 as substantially equivalent to K862359 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 61-day review. Its family tree reaches back 1 generation to 1986.

Decided
Aug 29, 2006
Review
61 days
Class
Class II
Product code
CIG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K862359 (1986). No later device cites it as a predicate yet.

K862359 · Meth./Cali./Intru. Check for the Dimension System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled19851990199520002005
K862359 · Meth./Cali./Intru. Check for the Dimension System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled0
  1. Root · 1 generation backK862359 Meth./Cali./Intru. Check for the Dimension SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
  2. This deviceK061839 Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K862359Meth./Cali./Intru. Check for the Dimension SystemE.I. Dupont DE Nemours & Co., Inc.19862
0 (this device)K061839Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc.2006—
FIG. 1 — Lineage of K061839, 1986–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K862359Meth./Cali./Intru. Check for the Dimension System
Summary page 1
…® reagent cartridge FDA Classification Name: Bilimbin (total or direct) test system Predicate Device: Dade Behring DBIL Flex® reagent cartridge (k862359) Device Description: Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. The sample…
E.I. Dupont DE Nemours & Co., Inc.19862

Also cleared against K862359: 3 other devices →

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.
  • 3 other devices also cite its predicate K862359.

How does its category compare?

All CIG devices

CIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIG

2in 2023

2007: 12008: 32009: 22010: 12011: 22013: 52015: 12017: 12019: 12022: 12023: 22026 (partial year): 1
2007high 5 (2013) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIG

64in 2013

2008: 199 days median2013: 64 days median
2007high 199 (2008) · low 64 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CIG

1in 2019

2009: 32013: 32019: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CIG

52in 2025

2007: 22008: 82009: 32010: 62011: 382012: 142013: 82014: 32015: 72016: 42017: 112018: 232019: 252020: 312021: 222022: 262023: 342024: 392025: 52
2007high 52 (2025) · low 2 (2007)2025

MAUDE reports naming product code CIG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
2008319908
20092—33
20101—06
20112—038
20120—014
201356438
20140—03
20151—07
20160—04
20171—011
20180—023
20191—125
20200—031
20210—022
20221—026
20232—034
20240—039
20250—052
20261—0—

What is it indicated for?

The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct

(conjugated) bilirubin in human serum and plasma on the Dimension Vista System.

Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic,

hematological and metabolic disorders, including hepatitis and gall bladder disease.

Indications for use as stated in the FDA summary.

Also cleared against K862359

3 other devices cite the same predicate.

  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 20067 recalls
  • K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino…Dade Behring, Inc. · 20061 recall
  • K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc. · 20061 recall

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in CIG

The CIG category page

  • K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026
  • K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K223324Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
  • K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc. · 20193 recalls

https://510kreport.com/device/K061839 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061839: Dimension Vista Dbil Flex Reagent Cartridge, Model K2125.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061839

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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