Cleared Traditional

K902639 - EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)

K902639 is the FDA 510(k) clearance for EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) by Incstar Corp.. It is a Class 2 Hematology device (product code GGT) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K902639 · Incstar Corp. · Hematology device
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Aug 1990
Decision
69d
Days
Class 2
Risk

K902639 is an FDA 510(k) clearance for the EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA). Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7250 - 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 Incstar Corp. devices

Submission Details

510(k) Number K902639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date August 22, 1990
Days to Decision 69 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
44d faster than avg
Panel avg: 113d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGT Assay, Erythropoietin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7250
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 - GGT Assay, Erythropoietin

All 10
Devices cleared under the same product code (GGT) and FDA review panel - the closest regulatory comparables to K902639.
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
K931756 · R&D Systems, Inc. · Apr 1994
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
K931666 · R&D Systems, Inc. · Jul 1993
DSL ERYTHROPOIETIN (DSL # 1100)
K903492 · Diagnostic Systems Laboratories, Inc. · Oct 1990
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
K893393 · Incstar Corp. · Nov 1989