510(k) · Cleared
ClearedDimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LAR Enzyme Immunoassay, Procainamide
Cleared on Oct 31, 2003 as substantially equivalent to K833384 (E.I. Dupont DE Nemours & Co., Inc., 1983) after a 72-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Oct 31, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- LAR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833384 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK833384 Procainamide Analytical Test PackE.I. Dupont DE Nemours & Co., Inc. · 1983
- This deviceK032573 Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model…Dade Behring, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
- Descendant · 2 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833384 | Procainamide Analytical Test Pack | E.I. Dupont DE Nemours & Co., Inc. | 1983 | — |
| 0 (this device) | K032573 | Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110 | Dade Behring, Inc. | 2003 | — |
| +1 | K061655 | Dimension Vista Flex Reagent Cartridges | Dade Behring, Inc. | 2006 | 7 |
| +2 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium… | Siemens Healthcare Diagnostics | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
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 LAR? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K833384 | Procainamide Analytical Test PackSummary page 1…FDA Classification Name: Procainamide test system (2 1CFRs862.3320; 9 1LAR) Predicate Device: Dade Behring aca@ PROC analytical test pack (K833384) Device Description: The Dade Behring Dimension@Procainamide (PROC) Flex@ reagent cartridge method is an in vitro diagnostic te… | 1983 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061655 | Dimension Vista Flex Reagent Cartridges | 2006 | 1 |
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 no recall.
- Of its descendants, K061655 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LAR devicesLAR 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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dade Behring Dimension@ Procainamide (PROC) Flex@ reagent cartridge method
is used to measure procainamide in serum or plasma. Measurements obtained may be
used in the diagnosis and treatment of procainamide overdose and in monitoring levels of
procainamide to emure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032573: Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032573
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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