Cleared Traditional

PREDICTA ERYTHROPOIETIN KIT (K926390) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K926390 · Genzyme Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.