Cleared Traditional

ACCULEVEL PHENOBARBITAL TEST (K854607) - FDA 510(k) Clearance

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

K854607 · Syva Co. · Toxicology device
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Aug 1986
Decision
280d
Days
Class 2
Risk

K854607 is an FDA 510(k) clearance for the ACCULEVEL PHENOBARBITAL TEST. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 25, 1986 after a review of 280 days - an extended review 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: 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 K854607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date August 25, 1986
Days to Decision 280 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
193d slower than avg
Panel avg: 87d · This submission: 280d
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
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