Cleared Traditional

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

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

K902639 · Incstar Corp. · Hematology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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.

FDA 510(k) Submission Details - K902639

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.

GGT Device Classification - Class 2, Special Controls

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 19

Devices cleared under the same product code (GGT) and FDA review panel - the closest regulatory comparables to K902639.

PREDICTA ERYTHROPOIETIN KIT

K926390 · Genzyme Corp. · Jun 1993

EPO-RIA

K910481 · Ramco Laboratories, Inc. · Nov 1991

DSL ERYTHROPOIETIN (DSL # 1100)

K903492 · Diagnostic Systems Laboratories, Inc. · Oct 1990

EPO-TRAC BY RADIOIMMUNOASSAY (RIA)

K893393 · Incstar Corp. · Nov 1989

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

K894943 · Amgen, Inc. · Oct 1989

ERYTHROPOIETIN ENZYME IMMUNOASSAY

K882686 · Amgen, Inc. · Dec 1988

FDA 510(k) Resources - Hematology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K902639

Incstar Corp.

Stillwater, MN · US

DAVID H SHORT

Regulatory profile

58 submissions 57 cleared

98% clearance rate · Active in Hematology

View all devices by Incstar Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: August 22, 1990. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026