Cleared Special

K011528 - EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

K011528 is an FDA 510(k) clearance for EMIT 2000 PHENOBARBITAL ASSAY, manufactured by Syva Co.. The device is a Class 2 Chemistry device with product code DLZ cleared through the Special 510(k) pathway after a 20-day FDA review.

K011528 · Syva Co. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
20d
Days
Class 2
Risk

K011528 is an FDA 510(k) clearance for the EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3660 - the FDA in vitro diagnostics and chemistry 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 - K011528

510(k) Number K011528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2001
Decision Date June 06, 2001
Days to Decision 20 days
Submission Type Special
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
69d faster than avg
Panel avg: 89d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

DLZ Device Classification - Class 2, Special Controls

Product Code DLZ Enzyme Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - DLZ Enzyme Immunoassay, Phenobarbital

All 34
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K011528.
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
K081231 · Abbott Laboratories · Sep 2008
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644 · Roche Diagnostics Corp. · Sep 2007
RANDOX PHENOBARBITAL
K011303 · Randox Laboratories, Ltd. · Jul 2001
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012 · Diagnostic Products Corp. · Mar 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · Syva Co. · Jan 2000
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
K011528 · EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
Download PDF FDA Summary Syva Co.