Cleared Traditional

MINIQUANT D-DIMER, MODEL 1447 (K002642) - FDA 510(k) Clearance

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

K002642 · Biopool Intl., Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
165d
Days
Class 2
Risk

K002642 is an FDA 510(k) clearance for the MINIQUANT D-DIMER, MODEL 1447. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Biopool Intl., Inc. (Ventura, US). The FDA issued a Cleared decision on February 5, 2001 after a review of 165 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 Intl., Inc. devices

Submission Details

510(k) Number K002642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2000
Decision Date February 05, 2001
Days to Decision 165 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
52d slower than avg
Panel avg: 113d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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 - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

All 56
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K002642.
HemosIL D-Dimer HS 500
K172903 · Instrumentation Laboratory CO · Nov 2017
HemosIL D-Dimer HS
K160885 · Instrumentation Laboratory CO · Oct 2016
HemosIL D-Dimer HS
K151534 · Instrumentation Laboratory CO · Jul 2015
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · bioMerieux, Inc. · Jul 2012
HEMOSIL D-DIMER HS 500, CONTROLS
K090264 · Instrumentation Laboratory CO · Feb 2010
HEMOSIL D-DIMER HS
K070927 · Instrumentation Laboratory CO · Sep 2007