510(k) · Cleared

Recalled · Class II · 2020

Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator

K060628510(k) SpecialCleared Apr 6, 200628-day reviewClass II21 CFR 862.1110Recalls 1

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 Apr 6, 2006 as substantially equivalent to K861700 (E.I. Dupont DE Nemours & Co., Inc., 1986) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.

Decided: Apr 6, 2006
Review: 28 days
Class: Class II
Product code: CIG
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K861700 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK861700 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
This deviceK060628 Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi…Dade Behring, Inc. · 2006
Descendant · cites it directly · 0 of its ownK222104 Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all

K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023 · 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)	K060628	Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator	Dade Behring, Inc.	2006	—
+1	K222104	Atellica® CH Diazo Total Bilirubin (D_TBil)	Siemens Healthcare Diagnostics, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K060628, 1986–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K861700	Dimension (TM) Clinical Chemistry System Summary page 1 …ilirubin (total or direct) test system Bilirubin Calibrator Predicate Device: Dade Behring TBIL Flex® reagent cartridge (k861700) Dade Behring DBIL Flex® reagent cartridge (k862359) Dade Behri…	E.I. Dupont DE Nemours & Co., Inc.	1986	2
*	K862359	Meth./Cali./Intru. Check for the Dimension System Summary page 1 …ibrator Predicate Device: Dade Behring TBIL Flex® reagent cartridge (k861700) Dade Behring DBIL Flex® reagent cartridge (k862359) Dade Behring TBIL/DBIL Calibrator (k861700) Device Description Total Bilirubin/Direct Bilirub…	E.I. Dupont DE Nemours & Co., Inc.	1986	2

Also cleared against K861700: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K222104	Atellica® CH Diazo Total Bilirubin (D_TBil)	Siemens Healthcare Diagnostics, Inc.	2023	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 13, 2020	Class II	Z-1540-2020	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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K222104 (Siemens Healthcare Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K861700.

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

2007high 5 (2013) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIG

64in 2013

2007high 199 (2008) · low 64 (2013)2026

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

Recalls per year · CIG

1in 2019

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

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

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?

TBI Flex® reagent cartridge: The TBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease. DBI Flex® reagent cartridge: The DBI method for the Dimension® clinical chemistry…

Read the full statement (161 words)

TBI Flex® reagent cartridge:

The TBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.

DBI Flex® reagent cartridge:

The DBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure direct bilirubin in human serum and plasma. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disease.

TBI/DB1 Calibrator:

The Dimension® Bilirubin Calibrator is an in vitro diagnostic product intended to be used to calibrate the Direct Bilirubin (DBI) and Total Bilirubin (TBI) methods for the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of these methods.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K060628 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060628: Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060628

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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