Cleared Traditional

K051211 - QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

K051211 is an FDA 510(k) clearance for QMS ZONISAMIDE REAGENTS, manufactured by Seradyn, Inc.. The device is a Class 2 Chemistry device with product code NWM cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K051211 · Seradyn, Inc. · Chemistry device
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Nov 2005
Decision
191d
Days
Class 2
Risk

K051211 is an FDA 510(k) clearance for the QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS. Classified as Immunoassay, Anti-seizure Drug (product code NWM), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 191 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Seradyn, Inc. devices

FDA 510(k) Submission Details - K051211

510(k) Number K051211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2005
Decision Date November 18, 2005
Days to Decision 191 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 88d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NWM Device Classification - Class 2, Special Controls

Product Code NWM Immunoassay, Anti-seizure Drug
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
Definition To Aid In Management Of Patients Treated With Anti-seizure Drug.
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 Chemistry devices follow this clearance model.

Regulatory Peers - NWM Immunoassay, Anti-seizure Drug

Devices cleared under the same product code (NWM) and FDA review panel - the closest regulatory comparables to K051211.
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
K091884 · ARK Diagnostics, Inc. · Dec 2009
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
K083799 · ARK Diagnostics, Inc. · Apr 2009
SERADYN QMS TOPIRAMATE
K070645 · Seradyn, Inc. · May 2007