Cleared Traditional

COULTER LIN-X LINEARITY CONTROL (K081641) - FDA 510(k) Clearance

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

K081641 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
219d
Days
Class 2
Risk

K081641 is an FDA 510(k) clearance for the COULTER LIN-X LINEARITY CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 219 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K081641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2008
Decision Date January 16, 2009
Days to Decision 219 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 113d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 191
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K081641.
XN-L CHECK
K160586 · Streck · Dec 2016
XN CHECK BF
K160588 · Streck · Dec 2016
XN CHECK
K160590 · Streck · Dec 2016
BC-5D Hematology Control
K160606 · R&D Systems, Inc. · Sep 2016
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · Bio-Rad · Nov 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · Bio-Rad · Jun 2004