Cleared Traditional

K893038 - PROTOFLUOR Z

K893038 is an FDA 510(k) clearance for PROTOFLUOR Z, manufactured by Helena Laboratories. The device is a Class 1 Chemistry device with product code JKJ cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K893038 · Helena Laboratories · Chemistry device
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Nov 1989
Decision
207d
Days
Class 1
Risk

K893038 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 November 17, 1989 after a review of 207 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1595 - 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 Helena Laboratories devices

FDA 510(k) Submission Details - K893038

510(k) Number K893038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date November 17, 1989
Days to Decision 207 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

JKJ Device Classification - Class 1, General Controls

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.