510(k) Report

510(k) · Cleared

Cleared

TDX N-Acetylprocainamide

K830206510(k) TraditionalCleared Feb 18, 198328-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

Abbott Laboratories · LAN Enzyme Immunoassay, N-Acetylprocainamide

Cleared on Feb 18, 1983 after a 28-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
Feb 18, 1983
Review
28 days
Class
Class II
Product code
LAN
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1997: 1 descendant cleared19801990200020102020
  1. This deviceK830206 TDX N-AcetylprocainamideAbbott Laboratories · 1983
  2. Descendant · cites it directly · 1 of its ownK962269 Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp. · 1996
  3. Descendant · 2 generations on · 0 of its ownK972433 Cedia Digoxin CalibratorsBoehringer Mannheim Corp. · 1997
  4. Descendant · cites it directly · 0 of its ownK963306 Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp. · 1996

Most influential descendants

Showing 3 of 3 · See all
  • K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp. · 1996 · cites it directly1descendant
  • K972433Cedia Digoxin CalibratorsBoehringer Mannheim Corp. · 1997 · 2 generations on0descendants
  • K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K830206TDX N-AcetylprocainamideAbbott Laboratories1983—
+1K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp.1996—
+2K972433Cedia Digoxin CalibratorsBoehringer Mannheim Corp.1997—
+1K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
FIG. 1 — Lineage of K830206, 1983–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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)

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

NumberDeviceApplicantDecidedDescendants
K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp.19961
K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp.19960

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, K962269 (Boehringer Mannheim Corp., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LAN devices

LAN Enzyme Immunoassay, N-Acetylprocainamide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAN

FDA has decided no LAN device since 2007.

Median 510(k) review, days · LAN

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

Recalls per year · LAN

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LAN

No MAUDE report names LAN 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—10
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 Abbott Laboratories

1,433 FDA decisions under this applicant name. See the company

  • K262156Anti-HCV NextAbbott Laboratories · 2026
  • P120008/S032ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)Abbott Laboratories · 2026
  • K252424Anti-HCV NextAbbott Laboratories · 2026
  • P910007/S068ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026
  • P910007/S067ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026

Recent decisions in LAN

The LAN category page

  • K060738TDM N-AcetylprocainamideRoche Diagnostics Corp. · 20061 recall
  • K032564Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111Dade Behring, Inc. · 2003
  • K011620Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229Syva Co., Dade Behring, Inc. · 2001
  • K983812Napa Eia AssayDiagnostic Reagents, Inc. · 1998
  • K971713N-Acetylprocainamide Assay for the Bayer Immuno 1 SystemBayer Corp. · 1997

https://510kreport.com/device/K830206 · printed Nov 3, 2026

Cite this page

510(k) Report. “K830206: TDX N-Acetylprocainamide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830206

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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