Cleared Traditional

K931241 - FAST'N'FLAMMATORY KIT (FDA 510(k) Clearance)

Class I Hematology device.

K931241 · Techlab, Inc. · Hematology device
Feb 1994
Decision
329d
Days
Class 1
Risk

K931241 is an FDA 510(k) clearance for the FAST'N'FLAMMATORY KIT. Classified as Test, Leukocyte Peroxidase (product code GIA), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 329 days — an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7675 — the FDA hematology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K931241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1993
Decision Date February 03, 1994
Days to Decision 329 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 205d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIA Test, Leukocyte Peroxidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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.