Cleared Traditional

CELL-CHEX (K101335) - FDA 510(k) Clearance

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

K101335 · Streck · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
103d
Days
Class 2
Risk

K101335 is an FDA 510(k) clearance for the CELL-CHEX. Classified as Mixture, Control, White-cell And Red-cell Indices (product code GLQ), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on August 23, 2010 after a review of 103 days - within the typical 510(k) review window.

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 K101335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date August 23, 2010
Days to Decision 103 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
10d faster than avg
Panel avg: 113d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GLQ Mixture, Control, White-cell And Red-cell Indices
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.