510(k) Report

510(k) · Cleared

Cleared

Emit 2000 Procainamide Assay, Model OSR4K229

K010812510(k) SpecialCleared Apr 13, 200125-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

Syva Co., Dade Behring, Inc. · LAR Enzyme Immunoassay, Procainamide

Cleared on Apr 13, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 13, 2001
Review
25 days
Class
Class II
Product code
LAR
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K010812Source: FDA 510(k) database · 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 LAR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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?

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.

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 Syva Co., Dade Behring, Inc.

19 FDA decisions under this applicant name. See the company

  • K011920Emit 2000 Digoxin Assay, Model OSR4H229Syva Co., Dade Behring, Inc. · 2001
  • K011620Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229Syva Co., Dade Behring, Inc. · 2001
  • K011605Emit 2000 Quinidine Assay, Model OSR4Q229Syva Co., Dade Behring, Inc. · 20011 recall
  • K011300Emit II Plus Cannabinoid Assay, Model OSR9N229Syva Co., Dade Behring, Inc. · 2001
  • K011306Emit II Plus Benzodiazepine Assay, Model 0SR9F229Syva Co., Dade Behring, Inc. · 2001

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
  • K971716Procainamide Assay for the Bayer Immuno 1 SystemBayer Corp. · 1997
  • K963306Cedia N-Acetylprocainamide AssayBoehringer Mannheim Corp. · 1996
  • K962099Cedia Procainamide AssayBoehringer Mannheim Corp. · 1996

https://510kreport.com/device/K010812 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010812: Emit 2000 Procainamide Assay, Model OSR4K229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010812

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026