Cleared Traditional

K931666 - QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY

K931666 is an FDA 510(k) clearance for QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK ..., manufactured by R&D Systems, Inc.. The device is a Class 2 Hematology device with product code GGT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K931666 · R&D Systems, Inc. · Hematology device
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Jul 1993
Decision
105d
Days
Class 2
Risk

K931666 is an FDA 510(k) clearance for the QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY. Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 20, 1993 after a review of 105 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.

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FDA 510(k) Submission Details - K931666

510(k) Number K931666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date July 20, 1993
Days to Decision 105 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
8d faster than avg
Panel avg: 113d · This submission: 105d
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 K931666.
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
K954898 · Genzyme Corp. · Feb 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
PREDICTA ERYTHROPOIETIN KIT
K926390 · Genzyme Corp. · Jun 1993
DSL ERYTHROPOIETIN (DSL # 1100)
K903492 · Diagnostic Systems Laboratories, Inc. · Oct 1990
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639 · Incstar Corp. · Aug 1990