510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Meth./Cali./Intru. Check for the Dimension System

K862359510(k) TraditionalCleared Aug 19, 198657-day reviewClass II21 CFR 862.1110Recalls 2

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

E.I. Dupont DE Nemours & Co., Inc. · CIG Diazo Colorimetry, Bilirubin

Cleared on Aug 19, 1986 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.

Decided
Aug 19, 1986
Review
57 days
Class
Class II
Product code
CIG
Recalls
2
Predicates
0

6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 4 descendants cleared2023: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK862359 Meth./Cali./Intru. Check for the Dimension SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
  3. Descendant · cites it directly · 1 of its ownK060628 Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi…Dade Behring, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK222104 Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
  5. Descendant · 2 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
  6. Descendant · cites it directly · 0 of its ownK061839 Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc. · 2006

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 42015: 12023: 1
2006high 4 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · cites it directly1descendant
  • K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc. · 2006 · cites it directly1descendant
  • K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
  • K061839Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862359Meth./Cali./Intru. Check for the Dimension SystemE.I. Dupont DE Nemours & Co., Inc.1986—
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20067
+1K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc.20061
+2K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.2023—
+2K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…Siemens Healthcare Diagnostics20152
+1K061839Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200640
201510
202310
FIG. 1 — Lineage of K862359, 1986–2023Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20061
K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc.20061
K061839Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc.20060
K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.20060

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 29, 2017Class IIZ-1654-2018Device DesignVarious assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
Mar 17, 2016Class IIZ-1662-2016Device DesignSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061655 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.

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—

More from E.I. Dupont DE Nemours & Co., Inc.

253 FDA decisions under this applicant name. See the company

  • K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayE.I. Dupont DE Nemours & Co., Inc. · 1996
  • K953724Cronex Radiation Therapy CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K953725Cronex Radiation Therapy Verification CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K951441Dupont Aca Digoxin (DGN a) MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K950137Urine Barbiturates Screen Flex (TM) Reagent CartridgeE.I. Dupont DE Nemours & Co., Inc. · 1995

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/K862359 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862359: Meth./Cali./Intru. Check for the Dimension System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862359

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026