Cleared Traditional

K160588 - XN CHECK BF

K160588 is the FDA 510(k) clearance for XN CHECK BF by Streck. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K160588 · Streck · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
296d
Days
Class 2
Risk

K160588 is an FDA 510(k) clearance for the XN CHECK BF. 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 22, 2016 after a review of 296 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 Streck devices

Submission Details

510(k) Number K160588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date December 22, 2016
Days to Decision 296 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 113d · This submission: 296d
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 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K160588.
XN-L CHECK
K160586 · Streck · Dec 2016
XN CHECK
K160590 · Streck · Dec 2016
BC-5D Hematology Control
K160606 · R&D Systems, Inc. · Sep 2016
R&D 5D RETIC HEMATOLOGY CONTROL
K130962 · R&D Systems, Inc. · Jul 2013
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
K101578 · R&D Systems, Inc. · Apr 2011
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
K100790 · Beckman Coulter, Inc. · Dec 2010