Cleared Special

K011347 - EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

K011347 is an FDA 510(k) clearance for EMIT 2000 PHENYTOIN ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code DIP cleared through the Special 510(k) pathway after a 15-day FDA review.

K011347 · Syva Co. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
15d
Days
Class 2
Risk

K011347 is an FDA 510(k) clearance for the EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 17, 2001 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011347

510(k) Number K011347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date May 17, 2001
Days to Decision 15 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

DIP Device Classification - Class 2, Special Controls

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - DIP Enzyme Immunoassay, Diphenylhydantoin

All 43
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K011347.
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
K063145 · Thermo Electron OY · Oct 2007
ROCHE ONLINE TDM PHENYTOIN
K030428 · Roche Diagnostics Corp. · Apr 2003
RANDOX PHENYTOIN
K011393 · Randox Laboratories, Ltd. · Dec 2001
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
K000006 · Diagnostic Products Corp. · Feb 2000
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · Syva Co. · Jan 2000
ACE PHENYTOIN REAGENT, AED CALIBRATORS
K973414 · Schiapparelli Biosystems, Inc. · Nov 1997
K011347 · EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
Download PDF FDA Summary Syva Co.