Cleared Traditional

K954898 - PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)

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

K954898 · Genzyme Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954898

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
Combination Product No
PCCP Authorized No
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.

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 14
Devices cleared under the same product code (GGT) and FDA review panel - the closest regulatory comparables to K954898.
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203 · Diagnostic Products Corp. · Jul 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
K980737 · Nichols Institute Diagnostics · Mar 1999
ERYTHROPOIETIN IMMUNOASSAY KIT
K952559 · Nichols Institute · May 1996
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