Cleared Traditional

K931241 - FAST'N'FLAMMATORY KIT

K931241 is an FDA 510(k) clearance for FAST'N'FLAMMATORY KIT, manufactured by Techlab, Inc.. The device is a Class 1 Hematology device with product code GIA cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K931241 · Techlab, Inc. · Hematology device
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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.

View all Techlab, Inc. devices

FDA 510(k) Submission Details - K931241

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 113d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

GIA Device Classification - Class 1, General Controls

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.