Cleared Traditional

K083200 - X-CAL

K083200 is an FDA 510(k) clearance for X-CAL, manufactured by Streck. The device is a Class 2 Hematology device with product code KRX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K083200 · Streck · Hematology device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
96d
Days
Class 2
Risk

K083200 is an FDA 510(k) clearance for the X-CAL. Classified as Calibrator For Cell Indices (product code KRX), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 3, 2009 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8150 - 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 - K083200

510(k) Number K083200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2008
Decision Date February 03, 2009
Days to Decision 96 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
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRX Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (KRX) and FDA review panel - the closest regulatory comparables to K083200.
XN CAL PF
K120747 · Streck · Oct 2012
XN CAL
K120745 · Streck · Oct 2012
CELL-DYN 22 PLUS CALIBRATOR
K111204 · Streck · Dec 2011
CAL-CHEX CD PLUS
K020469 · Streck Laboratories, Inc. · Apr 2002
CD-CAL PLUS CALIBRATOR
K003991 · R&D Systems, Inc. · Jan 2001
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K993375 · Clinical Diagnostic Solutions, Inc. · Dec 1999