Cleared Traditional

K894851 - TRU-TRAX

K894851 is an FDA 510(k) clearance for TRU-TRAX, manufactured by Humagen, Inc.. The device is a Class 1 Hematology device with product code GIO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K894851 · Humagen, Inc. · Hematology device
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Sep 1989
Decision
60d
Days
Class 1
Risk

K894851 is an FDA 510(k) clearance for the TRU-TRAX. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Humagen, Inc. (Charlottesville, US). The FDA issued a Cleared decision on September 29, 1989 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6150 - 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.

FDA 510(k) Submission Details - K894851

510(k) Number K894851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date September 29, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

GIO Device Classification - Class 1, General Controls

Product Code GIO Tube, Collection, Capillary Blood
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6150
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.

Regulatory Peers - GIO Tube, Collection, Capillary Blood

All 21
Devices cleared under the same product code (GIO) and FDA review panel - the closest regulatory comparables to K894851.
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · Innovative Medical Technologies, Inc. · Sep 1997
MONOJECT SAMPLETTE SEPARATOR TUBE
K941291 · Sherwood Medical Co. · Oct 1994
HEMA(PRO)TEC(TION)
K885324 · Medical Products Search, Inc. · Feb 1989
CAPILLARY TUBE, BLOOD COLLECTION
K885138 · Coeur Laboratories, Inc. · Feb 1989
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
K884623 · Safe-Tec Clinical Products, Inc. · Dec 1988
NATELSON TUBES, HEPARIN AND PLAIN
K881187 · Helps Products, Inc. · May 1988
K894851 · TRU-TRAX
Download PDF Humagen, Inc.