Cleared Traditional

K071644 - ONLINE PHENOBARBITAL

K071644 is the FDA 510(k) clearance for ONLINE PHENOBARBITAL by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K071644 · Roche Diagnostics Corp. · Toxicology device
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Sep 2007
Decision
89d
Days
Class 2
Risk

K071644 is an FDA 510(k) clearance for the ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 12, 2007 after a review of 89 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K071644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2007
Decision Date September 12, 2007
Days to Decision 89 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
2d slower than avg
Panel avg: 87d · This submission: 89d
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 28
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