Cleared Traditional

K994388 - XE CHECK

K994388 is an FDA 510(k) clearance for XE CHECK, 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 17-day FDA review.

K994388 · Streck Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
17d
Days
Class 2
Risk

K994388 is an FDA 510(k) clearance for the XE CHECK. 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 January 14, 2000 after a review of 17 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 Laboratories, Inc. devices

FDA 510(k) Submission Details - K994388

510(k) Number K994388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date January 14, 2000
Days to Decision 17 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
96d faster than avg
Panel avg: 113d · This submission: 17d
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 K994388.
CELL-CHEX
K101335 · Streck · Aug 2010
STAK-CHEX PLUS RETICS
K090137 · Streck · Mar 2009
PARA 12 PLUS RETICS
K000945 · Streck Laboratories, Inc. · Apr 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