510(k) Report

510(k) · Cleared

Cleared

Procainamide Analytical Test Pack

K833384510(k) TraditionalCleared Dec 27, 198389-day reviewClass II21 CFR 862.3320

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. · LAR Enzyme Immunoassay, Procainamide

Cleared on Dec 27, 1983 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Dec 27, 1983
Review
89 days
Class
Class II
Product code
LAR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2006: 1 descendant cleared2015: 1 descendant cleared19801990200020102020
  1. This deviceK833384 Procainamide Analytical Test PackE.I. Dupont DE Nemours & Co., Inc. · 1983
  2. Descendant · cites it directly · 2 of its ownK032573 Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model…Dade Behring, Inc. · 2003
  3. Descendant · 2 generations on · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K032573Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110Dade Behring, Inc. · 2003 · cites it directly2descendants
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · 2 generations on1descendant
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K833384Procainamide Analytical Test PackE.I. Dupont DE Nemours & Co., Inc.1983—
+1K032573Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110Dade Behring, Inc.2003—
+2K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20067
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…Siemens Healthcare Diagnostics20152

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
201510
FIG. 1 — Lineage of K833384, 1983–2015Source: 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.

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  • 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K032573Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110Dade Behring, Inc.20032

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, K032573 (Dade Behring, Inc., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LAR devices

LAR Enzyme Immunoassay, Procainamide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAR

FDA has decided no LAR device since 2007.

Median 510(k) review, days · LAR

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

Recalls per year · LAR

No recall names LAR since 2007.

Adverse event reports per year · LAR

No MAUDE report names LAR 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

Recent decisions in LAR

The LAR category page

  • K060773Online TDM ProcainamideRoche Diagnostics Corp. · 2006
  • K032573Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110Dade Behring, Inc. · 2003
  • K010812Emit 2000 Procainamide Assay, Model OSR4K229Syva Co., Dade Behring, Inc. · 2001
  • K971716Procainamide Assay for the Bayer Immuno 1 SystemBayer Corp. · 1997
  • K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp. · 1996

https://510kreport.com/device/K833384 · printed Nov 6, 2026

Cite this page

510(k) Report. “K833384: Procainamide Analytical Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833384

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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