510(k) Report

510(k) · Cleared

Cleared

Aca (R) Digitoxin Calibrator

K891093510(k) TraditionalCleared Apr 26, 198955-day reviewClass I21 CFR 866.5160

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. · DCJ Beta-Globulin, Antigen, Antiserum, Control

Cleared on Apr 26, 1989 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Apr 26, 1989
Review
55 days
Class
Class I
Product code
DCJ
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2016: 1 descendant cleared2006: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK891093 Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1989
  2. Descendant · cites it directly · 10 of its ownK990255 Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999
  3. Descendant · 2 generations on · 9 of its ownK032574 Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003
  4. Descendant · 3 generations on · 8 of its ownK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
  5. Descendant · 4 generations on · 2 of its ownK160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3…Siemens Healthcare Diagnostics, Inc. · 2016
  6. Descendant · 4 generations on · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12004: 12006: 22009: 12010: 12015: 12016: 12017: 12023: 1
1999high 2 (2006) · low 0 (2000)2026

Most influential descendants

Showing 5 of 11 · See all
  • K990255Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999 · cites it directly10descendants
  • K032574Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003 · 2 generations on9descendants
  • K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Dade Behring, Inc. · 2004 · 3 generations on8descendants
  • K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc. · 2016 · 4 generations on2descendants
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891093Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc.1989—
+1K990255Dimension Drug Calibrator II, Model DC49BDade Behring, Inc.1999—
+2K032574Dimension Drug Calibrator II, Model DC49CDade Behring, Inc.2003—
+3K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug…Dade Behring, Inc.2004—
+4K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc.2016—
+4K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20067

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200410
200620
200910
201010
201510
201610
201710
202310
FIG. 1 — Lineage of K891093, 1989–2023Source: 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 DCJ? 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
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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? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K990255Dimension Drug Calibrator II, Model DC49BDade Behring, Inc.199910

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?

  • Of its descendants, K990255 (Dade Behring, Inc., 1999) has gone furthest, with 10 descendants of its own.

How does its category compare?

All DCJ devices

DCJ Beta-Globulin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCJ

FDA has decided no DCJ device since 2007.

Median 510(k) review, days · DCJ

Too few DCJ 510(k)s in any year since 2007 to give a median.

Recalls per year · DCJ

No recall names DCJ since 2007.

Adverse event reports per year · DCJ

No MAUDE report names DCJ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—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

https://510kreport.com/device/K891093 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891093: Aca (R) Digitoxin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891093

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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