Cleared Traditional

K882686 - ERYTHROPOIETIN ENZYME IMMUNOASSAY

K882686 is an FDA 510(k) clearance for ERYTHROPOIETIN ENZYME IMMUNOASSAY, manufactured by Amgen, Inc.. The device is a Class 2 Hematology device with product code GGT cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K882686 · Amgen, Inc. · Hematology device
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Dec 1988
Decision
173d
Days
Class 2
Risk

K882686 is an FDA 510(k) clearance for the ERYTHROPOIETIN ENZYME IMMUNOASSAY. Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Amgen, Inc. (Thousand Oaks, US). The FDA issued a Cleared decision on December 20, 1988 after a review of 173 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 Amgen, Inc. devices

FDA 510(k) Submission Details - K882686

510(k) Number K882686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1988
Decision Date December 20, 1988
Days to Decision 173 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 113d · This submission: 173d
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.