Cleared Traditional

K090137 - STAK-CHEX PLUS RETICS

K090137 is the FDA 510(k) clearance for STAK-CHEX PLUS RETICS by Streck. It is a Class 2 Hematology device (product code GLQ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K090137 · Streck · Hematology device
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Mar 2009
Decision
56d
Days
Class 2
Risk

K090137 is an FDA 510(k) clearance for the STAK-CHEX PLUS RETICS. 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 March 18, 2009 after a review of 56 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 K090137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date March 18, 2009
Days to Decision 56 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
57d faster than avg
Panel avg: 113d · This submission: 56d
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.

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

Devices cleared under the same product code (GLQ) and FDA review panel - the closest regulatory comparables to K090137.
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
CONTROL TM 8
K823794 · General Diagnostics · Jan 1983
PARA 12
K823498 · Streck Laboratories, Inc. · Dec 1982