Cleared Traditional

K063218 - E-CHECK (XE)

K063218 is the FDA 510(k) clearance for E-CHECK (XE) by Streck. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K063218 · Streck · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
51d
Days
Class 2
Risk

K063218 is an FDA 510(k) clearance for the E-CHECK (XE). Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 51 days - a notably fast clearance 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: 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 Streck devices

Submission Details

510(k) Number K063218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2006
Decision Date December 14, 2006
Days to Decision 51 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
62d faster than avg
Panel avg: 113d · This submission: 51d
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 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K063218.
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · R&D Systems, Inc. · Nov 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K072268 · R&D Systems, Inc. · Nov 2007
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · R&D Systems, Inc. · Aug 2007
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · R&D Systems, Inc. · Jul 2006
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · R&D Systems, Inc. · Jun 2006
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
K061064 · Beckman Coulter, Inc. · May 2006