Cleared Traditional

K120745 - XN CAL

K120745 is an FDA 510(k) clearance for XN 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 221-day FDA review.

K120745 · Streck · Hematology device
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Oct 2012
Decision
221d
Days
Class 2
Risk

K120745 is an FDA 510(k) clearance for the XN 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 October 19, 2012 after a review of 221 days - an extended review cycle.

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.

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FDA 510(k) Submission Details - K120745

510(k) Number K120745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2012
Decision Date October 19, 2012
Days to Decision 221 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
108d slower than avg
Panel avg: 113d · This submission: 221d
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.