Cleared Traditional

K940596 - AXSYM PHENOBARBITAL

K940596 is an FDA 510(k) clearance for AXSYM PHENOBARBITAL, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LGQ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K940596 · Abbott Laboratories · Toxicology device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
131d
Days
Class 2
Risk

K940596 is an FDA 510(k) clearance for the AXSYM PHENOBARBITAL. Classified as Fluorescence Polarization Immunoassay, Phenobarbital (product code LGQ), Class II - Special Controls.

Submitted by Abbott Laboratories (Spartanburg, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 131 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K940596

510(k) Number K940596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date June 21, 1994
Days to Decision 131 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
44d slower than avg
Panel avg: 87d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGQ Device Classification - Class 2, Special Controls

Product Code LGQ Fluorescence Polarization 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 - LGQ Fluorescence Polarization Immunoassay, Phenobarbital

Devices cleared under the same product code (LGQ) and FDA review panel - the closest regulatory comparables to K940596.
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
K936130 · Roche Diagnostic Systems, Inc. · Mar 1994
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · Innotron of Oregon, Inc. · Apr 1990
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · Roche Diagnostic Systems, Inc. · Jul 1987
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
K862528 · Sclavo, Inc. · Jul 1986
TDX BARBITURATES
K854044 · Abbott Laboratories · Oct 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825 · Roche Diagnostic Systems, Inc. · Feb 1985