Cleared Traditional

K871499 - PROTOFLUOR Z (FDA 510(k) Clearance)

Class I Toxicology device.

K871499 · Helena Laboratories · Toxicology device
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Aug 1987
Decision
131d
Days
Class 1
Risk

K871499 is an FDA 510(k) clearance for the PROTOFLUOR Z. Classified as Fluorometric Measurement, Porphyrins (product code JKJ), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 25, 1987 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1595 - 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.

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Submission Details

510(k) Number K871499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1987
Decision Date August 25, 1987
Days to Decision 131 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 87d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKJ Fluorometric Measurement, Porphyrins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1595
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.