Cleared Traditional

K893393 - EPO-TRAC BY RADIOIMMUNOASSAY (RIA)

K893393 is an FDA 510(k) clearance for EPO-TRAC BY RADIOIMMUNOASSAY (RIA), manufactured by Incstar Corp.. The device is a Class 2 Chemistry device with product code GGT cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K893393 · Incstar Corp. · Chemistry device
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Nov 1989
Decision
204d
Days
Class 2
Risk

K893393 is an FDA 510(k) clearance for the EPO-TRAC BY 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 November 21, 1989 after a review of 204 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7250 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K893393

510(k) Number K893393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date November 21, 1989
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 89d · This submission: 204d
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 Chemistry 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 K893393.
EPO-RIA
K910481 · Ramco Laboratories, Inc. · Nov 1991
DSL ERYTHROPOIETIN (DSL # 1100)
K903492 · Diagnostic Systems Laboratories, Inc. · Oct 1990
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639 · Incstar Corp. · Aug 1990
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
K894943 · Amgen, Inc. · Oct 1989
ERYTHROPOIETIN ENZYME IMMUNOASSAY
K882686 · Amgen, Inc. · Dec 1988
ERYTHROPOIETIN EIA
K833957 · Jcl Clinical Research Corp. · Mar 1984
K893393 · EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
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