510(k) · Cleared
ClearedNapa Eia Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Reagents, Inc. · LAN Enzyme Immunoassay, N-Acetylprocainamide
Cleared on Nov 16, 1998 after a 19-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 16, 1998
- Review
- 19 days
- Class
- Class II
- Product code
- LAN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 devicesLAN 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
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
| 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 | — | 1 | 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 N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for
quantitative determination of N-acetylprocainamide in human serum or plasma. NAPA is the major
metabolite of procainamide. Its pharmacologic activity is almost equal to that of procainamide.
Furthermore, serum NAPA concentration may exceed its parent drug concentration. Therefore,
simultaneous measurement of procainamide and NAPA serum concentration is critical in achieving
optimal procainamide therapy.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983812: Napa Eia Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983812
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026