Cleared Traditional

K983812 - NAPA EIA ASSAY

K983812 is an FDA 510(k) clearance for NAPA EIA ASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code LAN cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K983812 · Diagnostic Reagents, Inc. · Toxicology device
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Nov 1998
Decision
19d
Days
Class 2
Risk

K983812 is an FDA 510(k) clearance for the NAPA EIA ASSAY. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K983812

510(k) Number K983812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date November 16, 1998
Days to Decision 19 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 87d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAN Device Classification - Class 2, Special Controls

Product Code LAN Enzyme Immunoassay, N-acetylprocainamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - LAN Enzyme Immunoassay, N-acetylprocainamide

All 19
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K983812.
TDM N-ACETYLPROCAINAMIDE
K060738 · Roche Diagnostics Corp. · Aug 2006
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · Dade Behring, Inc. · Oct 2003
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · Syva Co., Dade Behring, Inc. · Jun 2001
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · Bayer Corp. · Jun 1997
AXSYM N-ACETYLPROCAINAMIDE
K955422 · Abbott Laboratories · Apr 1996
OPUS NAPA
K934705 · Pb Diagnostic Systems, Inc. · Nov 1993