Cleared Traditional

K920668 - MINUTEX D-DIMER LATEX TEST

K920668 is an FDA 510(k) clearance for MINUTEX D-DIMER LATEX TEST, manufactured by Biopool AB. The device is a Class 2 Hematology device with product code GHH cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K920668 · Biopool AB · Hematology device
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Oct 1992
Decision
246d
Days
Class 2
Risk

K920668 is an FDA 510(k) clearance for the MINUTEX D-DIMER LATEX TEST. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Biopool AB (Ontario, L7l 6b8, CA). The FDA issued a Cleared decision on October 16, 1992 after a review of 246 days - an extended review 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: 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 Biopool AB devices

FDA 510(k) Submission Details - K920668

510(k) Number K920668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1992
Decision Date October 16, 1992
Days to Decision 246 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
133d slower than avg
Panel avg: 113d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GHH Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K920668.
SIMPLIFY D-DIMER, MODEL DCGK1
K993276 · Agen Biomedical , Ltd. · Dec 1999
OPUS D-DIMER
K972316 · Behring Diagnostics, Inc. · Sep 1997
FDP - SLIDEX DIRECT
K921989 · Biomerieux Vitek, Inc. · Nov 1993
ABBOTT IMX(TM) D-DIMER
K893961 · Abbott Laboratories · Aug 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · Abbott Laboratories · Mar 1989
MODIFIED D-DI-TEST KIT
K890399 · American Bioproducts Co. · Feb 1989