Cleared Abbreviated

K993375 - CDS LTX CONTROL LATEX PARTICLE SUSPENSI...

K993375 is the FDA 510(k) clearance for CDS LTX CONTROL LATEX PARTICLE SUSPENSI... by Clinical Diagnostic Solutions, Inc.. It is a Class 2 Hematology device (product code KRX) cleared through the Abbreviated 510(k) pathway after a 74-day FDA review.

K993375 · Clinical Diagnostic Solutions, Inc. · Hematology device
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Dec 1999
Decision
74d
Days
Class 2
Risk

K993375 is an FDA 510(k) clearance for the CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER. Classified as Calibrator For Cell Indices (product code KRX), Class II - Special Controls.

Submitted by Clinical Diagnostic Solutions, Inc. (Plantation, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8150 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Clinical Diagnostic Solutions, Inc. devices

Submission Details

510(k) Number K993375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1999
Decision Date December 20, 1999
Days to Decision 74 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 113d · This submission: 74d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KRX Calibrator For Cell Indices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8150
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 - KRX Calibrator For Cell Indices

All 8
Devices cleared under the same product code (KRX) and FDA review panel - the closest regulatory comparables to K993375.
XN CAL
K160585 · Streck · Dec 2016
CAL-CHEX CD PLUS
K020469 · Streck Laboratories, Inc. · Apr 2002
CD-CAL PLUS CALIBRATOR
K003991 · R&D Systems, Inc. · Jan 2001
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · R&D Systems, Inc. · Feb 1996
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · R&D Systems, Inc. · Jul 1991
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · R&D Systems, Inc. · Aug 1986