Cleared Traditional

ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS (K993031) - FDA 510(k) Clearance

Also marketed or referenced as:
MODELS 1E08 AND 5F54

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993031 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
140d
Days
Class 2
Risk

K993031 is an FDA 510(k) clearance for the ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS. 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 January 27, 2000 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K993031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date January 27, 2000
Days to Decision 140 days
Submission Type Traditional
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
53d slower than avg
Panel avg: 87d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Toxicology 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 K993031.
VITROS Chemistry Products PHBR Slides
K210858 · Ortho-Clinical Diagnostics, Inc. · Aug 2021
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
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · Syva Co. · Jun 2001
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012 · Diagnostic Products Corp. · Mar 2000
IL TEST PHENOBARBITAL CALIBRATORS
K943981 · Instrumentation Laboratory CO · Jan 1995