Cleared Traditional

K961984 - PORPHOBILINOGEN (PBG)

K961984 is an FDA 510(k) clearance for PORPHOBILINOGEN (PBG), manufactured by Trace America, Inc.. The device is a Class 1 Chemistry device with product code JNF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K961984 · Trace America, Inc. · Chemistry device
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Dec 1996
Decision
203d
Days
Class 1
Risk

K961984 is an FDA 510(k) clearance for the PORPHOBILINOGEN (PBG). Classified as Ion-exchange Resin, Ehrlich's Reagent, Porphobilinogen (product code JNF), Class I - General Controls.

Submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 203 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1590 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Trace America, Inc. devices

FDA 510(k) Submission Details - K961984

510(k) Number K961984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1996
Decision Date December 10, 1996
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

JNF Device Classification - Class 1, General Controls

Product Code JNF Ion-exchange Resin, Ehrlich's Reagent, Porphobilinogen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1590
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.