Cleared Traditional

K992887 - STAK-CHEX PLUS RETICS

K992887 is an FDA 510(k) clearance for STAK-CHEX PLUS RETICS, manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with product code GLQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K992887 · Streck Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
87d
Days
Class 2
Risk

K992887 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 Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on November 22, 1999 after a review of 87 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.

FDA 510(k) Submission Details - K992887

510(k) Number K992887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1999
Decision Date November 22, 1999
Days to Decision 87 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
26d faster than avg
Panel avg: 113d · This submission: 87d
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 9
Devices cleared under the same product code (GLQ) and FDA review panel - the closest regulatory comparables to K992887.
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
CONTROL TM 8
K823794 · General Diagnostics · Jan 1983
UNI-CELL
K823587 · Medical Specialties Laboratories · Jan 1983
PARA 12
K823498 · Streck Laboratories, Inc. · Dec 1982
K992887 · STAK-CHEX PLUS RETICS
Download PDF FDA Summary Streck Laboratories, …