Cleared Traditional

K926390 - PREDICTA ERYTHROPOIETIN KIT

K926390 is the FDA 510(k) clearance for PREDICTA ERYTHROPOIETIN KIT by Genzyme Corp.. It is a Class 2 Hematology device (product code GGT) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K926390 · Genzyme Corp. · Hematology device
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Jun 1993
Decision
185d
Days
Class 2
Risk

K926390 is an FDA 510(k) clearance for the PREDICTA ERYTHROPOIETIN KIT. Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Genzyme Corp. devices

Submission Details

510(k) Number K926390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date June 25, 1993
Days to Decision 185 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 113d · This submission: 185d
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 11
Devices cleared under the same product code (GGT) and FDA review panel - the closest regulatory comparables to K926390.
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K936016 · R&D Systems, Inc. · Jul 1994
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(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639 · Incstar Corp. · Aug 1990
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
K893393 · Incstar Corp. · Nov 1989