Cleared Traditional

K053362 - CELL-CHEX AUTO

K053362 is the FDA 510(k) clearance for CELL-CHEX AUTO by Streck. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K053362 · Streck · Hematology device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
42d
Days
Class 2
Risk

K053362 is an FDA 510(k) clearance for the CELL-CHEX AUTO. 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 January 13, 2006 after a review of 42 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 K053362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2005
Decision Date January 13, 2006
Days to Decision 42 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
71d faster than avg
Panel avg: 113d · This submission: 42d
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 K053362.
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
COULTER 5C CELL CONTROL
K060464 · Beckman Coulter, Inc. · Mar 2006
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · R&D Systems, Inc. · Jul 2005
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · Bio-Rad · Nov 2004
RETIC-CHEX FOR CELL-DYN
K042587 · Streck Laboratories, Inc. · Oct 2004