Cleared Traditional

K860046 - DETERMINATION OF PHENOBARBITAL

K860046 is the FDA 510(k) clearance for DETERMINATION OF PHENOBARBITAL by Clinical Data, Inc.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K860046 · Clinical Data, Inc. · Toxicology device
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Jan 1986
Decision
16d
Days
Class 2
Risk

K860046 is an FDA 510(k) clearance for the DETERMINATION OF PHENOBARBITAL. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 16 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K860046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 22, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
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 29
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K860046.
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926 · Em Diagnostic Systems, Inc. · Jan 1987
ACCULEVEL PHENOBARBITAL TEST
K854607 · Syva Co. · Aug 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
K862308 · Em Diagnostic Systems, Inc. · Jul 1986
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · Miles Laboratories, Inc. · Sep 1985
VENTREZYME PHENOBARBITAL KIT IMMUNO
K842264 · Ventrex Laboratories, Inc. · Aug 1984
CHEM KIT PHENOBARBITAL
K833796 · Abbott Laboratories · Jan 1984