Cleared Traditional

K884419 - TECHNICON RA-PHENOBARBITAL

K884419 is the FDA 510(k) clearance for TECHNICON RA-PHENOBARBITAL by Technicon Instruments Corp.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K884419 · Technicon Instruments Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
33d
Days
Class 2
Risk

K884419 is an FDA 510(k) clearance for the TECHNICON RA-PHENOBARBITAL. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 33 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Technicon Instruments Corp. devices

Submission Details

510(k) Number K884419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date November 22, 1988
Days to Decision 33 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 87d · This submission: 33d
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 31
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K884419.
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · Syva Co. · Aug 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · Instrumentation Laboratory CO · Apr 1991
OPUS PHENOBARBITAL TEST SYSTEM
K896861 · Pb Diagnostic Systems, Inc. · Jan 1990
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
K874625 · Syva Co. · Dec 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926 · Em Diagnostic Systems, Inc. · Jan 1987
ACCULEVEL PHENOBARBITAL TEST
K854607 · Syva Co. · Aug 1986