510(k) Report

510(k) · Cleared

Cleared

Opus Napa

K934705510(k) TraditionalCleared Nov 22, 199353-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

Pb Diagnostic Systems, Inc. · LAN Enzyme Immunoassay, N-Acetylprocainamide

Cleared on Nov 22, 1993 after a 53-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 22, 1993
Review
53 days
Class
Class II
Product code
LAN
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K934705Source: 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 LAN? 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 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 Pb Diagnostic Systems, Inc.

35 FDA decisions under this applicant name. See the company

  • K940507Opus FT4 Test SystemPb Diagnostic Systems, Inc. · 1994
  • K934762Opus Procainamide Test SystemPb Diagnostic Systems, Inc. · 1994
  • K933389Opus CMV-GPb Diagnostic Systems, Inc. · 1994
  • K934137Opus (R) Serology Controls, ModificationPb Diagnostic Systems, Inc. · 1994
  • K935229Opus DigitoxinPb Diagnostic Systems, Inc. · 1993

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/K934705 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934705: Opus Napa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934705

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