Cleared Traditional

SIMPLIFY D-DIMER, MODEL DCGK1 (K993276) - FDA 510(k) Clearance

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

K993276 · Agen Biomedical , Ltd. · Hematology device
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Dec 1999
Decision
75d
Days
Class 2
Risk

K993276 is an FDA 510(k) clearance for the SIMPLIFY D-DIMER, MODEL DCGK1. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Agen Biomedical , Ltd. (Brisbane, Queensland, AU). The FDA issued a Cleared decision on December 14, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Agen Biomedical , Ltd. devices

Submission Details

510(k) Number K993276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1999
Decision Date December 14, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 113d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHH Fibrin Split Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 - GHH Fibrin Split Products

All 27
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K993276.
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · Roche Diagnostics Corp. · Mar 2007
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · Roche Diagnostics Corp. · Apr 2003
MDA D-DIMER
K021877 · bioMerieux, Inc. · Aug 2002
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · Roche Diagnostics Corp. · May 2001
ABBOTT IMX(TM) D-DIMER
K893961 · Abbott Laboratories · Aug 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · Abbott Laboratories · Mar 1989