510(k) Report

510(k) · Cleared

Cleared

Cedia N-Acetylprocainamide Assay

K963306510(k) TraditionalCleared Oct 29, 199668-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

Boehringer Mannheim Corp. · LAR Enzyme Immunoassay, Procainamide

Cleared on Oct 29, 1996 as substantially equivalent to K830206 (Abbott Laboratories, 1983) after a 68-day review. Its family tree reaches back 1 generation to 1983.

Decided
Oct 29, 1996
Review
68 days
Class
Class II
Product code
LAR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K830206 (1983). No later device cites it as a predicate yet.

K830206 · TDX N-Acetylprocainamide · Abbott Laboratories · 19831980198519901995
K830206 · TDX N-Acetylprocainamide · Abbott Laboratories · 19830
  1. Root · 1 generation backK830206 TDX N-AcetylprocainamideAbbott Laboratories · 1983
  2. This deviceK963306 Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830206TDX N-AcetylprocainamideAbbott Laboratories1983—
0 (this device)K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp.1996—
FIG. 1 — Lineage of K963306, 1983–1996Source: 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), 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.

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  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K830206TDX N-Acetylprocainamide
Summary page 1
…oducts in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® N-acetylprocainamide Assay (K830206). Continued on next page —727- 10/10/96 17:58 510 574 HL2a BML CUNCOKD ho07/014 510(k) Summary, Continued 4.…
Abbott Laboratories1983—

Also cleared against K830206: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 1 other device also cites its predicate K830206.

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—

What is it indicated for?

Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma.

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

Also cleared against K830206

1 other device cites the same predicate.

  • K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp. · 1996

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

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
  • K962099Cedia Procainamide AssayBoehringer Mannheim Corp. · 1996

https://510kreport.com/device/K963306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963306: Cedia N-Acetylprocainamide Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963306

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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