Cleared Traditional

K915418 - ELLAGIC ACID APTT REAGENT

K915418 is the FDA 510(k) clearance for ELLAGIC ACID APTT REAGENT by Helena Laboratories. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K915418 · Helena Laboratories · Hematology device
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Feb 1992
Decision
74d
Days
Class 2
Risk

K915418 is an FDA 510(k) clearance for the ELLAGIC ACID APTT REAGENT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helena Laboratories devices

Submission Details

510(k) Number K915418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date February 14, 1992
Days to Decision 74 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 113d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GFO Activated Partial Thromboplastin

All 36
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K915418.
PLATELIN L
K921396 · Organon Teknika Corp. · Oct 1992
ACS FREEZE-DRIED APTT REAGENT
K921223 · Analytical Control Systems, Inc. · Aug 1992
ACS APCT REAGENT
K921118 · Analytical Control Systems, Inc. · Jul 1992
HEMOCHRON ONESTEP APTT TEST
K915344 · International Technidyne Corp. · Feb 1992
HEMOCHRON(R) APTT, MODIFICATION
K911994 · International Technidyne Corp. · Jul 1991
APTT REAGENT
K904341 · Sigma Chemical Co. · Nov 1990