Cleared Traditional

K980737 - ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY

K980737 is an FDA 510(k) clearance for ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIE..., manufactured by Nichols Institute Diagnostics. The device is a Class 2 Hematology device with product code GGT cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K980737 · Nichols Institute Diagnostics · Hematology device
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Mar 1999
Decision
391d
Days
Class 2
Risk

K980737 is an FDA 510(k) clearance for the ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY. Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on March 23, 1999 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Diagnostics devices

FDA 510(k) Submission Details - K980737

510(k) Number K980737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1998
Decision Date March 23, 1999
Days to Decision 391 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
278d slower than avg
Panel avg: 113d · This submission: 391d
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 K980737.
ACCESS EPO ASSAY
K052223 · Beckman Coulter, Inc. · Oct 2006
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
K992799 · Sangui Biotech, Inc. · Jun 2000
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203 · Diagnostic Products Corp. · Jul 1999
ERYTHROPOIETIN IMMUNOASSAY KIT
K952559 · Nichols Institute · May 1996
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
K954898 · Genzyme Corp. · Feb 1996
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K936016 · R&D Systems, Inc. · Jul 1994