Cleared Traditional

K954898 - PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)

K954898 is the FDA 510(k) clearance for PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) by Genzyme Corp.. It is a Class 2 Hematology device (product code GGT) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K954898 · Genzyme Corp. · Hematology device
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Feb 1996
Decision
138d
Days
Class 2
Risk

K954898 is an FDA 510(k) clearance for the PREDICTA ERYTHROPOIETIN KIT (MODIFICATION). Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on February 5, 1996 after a review of 138 days - within the typical 510(k) review window.

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 K954898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1995
Decision Date February 05, 1996
Days to Decision 138 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
25d slower than avg
Panel avg: 113d · This submission: 138d
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 K954898.
ACCESS EPO ASSAY
K052223 · Beckman Coulter, Inc. · Oct 2006
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203 · Diagnostic Products Corp. · Jul 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
K980737 · Nichols Institute Diagnostics · Mar 1999
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