Cleared Traditional

K101335 - CELL-CHEX

K101335 is an FDA 510(k) clearance for CELL-CHEX, manufactured by Streck. The device is a Class 2 Hematology device with product code GLQ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K101335 · Streck · Hematology device
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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

FDA 510(k) Submission Details - K101335

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
Combination Product No
PCCP Authorized No
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.

GLQ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GLQ Mixture, Control, White-cell And Red-cell Indices

All 8
Devices cleared under the same product code (GLQ) and FDA review panel - the closest regulatory comparables to K101335.
CELL-DYN 22 PLUS CONTROL
K111211 · Streck · Dec 2011
CELL-CHEX WITH CPPD CRYSTALS
K110718 · Streck · May 2011
STAK-CHEX PLUS RETICS
K090137 · Streck · Mar 2009
PARA 12 PLUS RETICS
K000945 · Streck Laboratories, Inc. · Apr 2000
XE CHECK
K994388 · Streck Laboratories, Inc. · Jan 2000
STAK-CHEX PLUS RETICS
K992887 · Streck Laboratories, Inc. · Nov 1999