Cleared Traditional

AGEN DIMERTEST GOLD EIA (K945642) - FDA 510(k) Clearance

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

K945642 · Agen Biomedical , Ltd. · Hematology device
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Oct 1995
Decision
343d
Days
Class 2
Risk

K945642 is an FDA 510(k) clearance for the AGEN DIMERTEST GOLD EIA. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Agen Biomedical , Ltd. (Brisbane, AU). The FDA issued a Cleared decision on October 25, 1995 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Agen Biomedical , Ltd. devices

Submission Details

510(k) Number K945642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date October 25, 1995
Days to Decision 343 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
230d slower than avg
Panel avg: 113d · This submission: 343d
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 K945642.
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