Cleared Traditional

K932650 - ERYTHROPOIETIN IMMUNOASSAY KIT

K932650 is an FDA 510(k) clearance for ERYTHROPOIETIN IMMUNOASSAY KIT, manufactured by Nichols Institute. The device is a Class 2 Hematology device with product code GGT cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K932650 · Nichols Institute · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
282d
Days
Class 2
Risk

K932650 is an FDA 510(k) clearance for the ERYTHROPOIETIN IMMUNOASSAY KIT. Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 282 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 Nichols Institute devices

FDA 510(k) Submission Details - K932650

510(k) Number K932650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date March 11, 1994
Days to Decision 282 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
169d slower than avg
Panel avg: 113d · This submission: 282d
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 15
Devices cleared under the same product code (GGT) and FDA review panel - the closest regulatory comparables to K932650.
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
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
K931666 · R&D Systems, Inc. · Jul 1993
PREDICTA ERYTHROPOIETIN KIT
K926390 · Genzyme Corp. · Jun 1993
DSL ERYTHROPOIETIN (DSL # 1100)
K903492 · Diagnostic Systems Laboratories, Inc. · Oct 1990