Cleared Traditional

K111204 - CELL-DYN 22 PLUS CALIBRATOR

K111204 is an FDA 510(k) clearance for CELL-DYN 22 PLUS CALIBRATOR, manufactured by Streck. The device is a Class 2 Hematology device with product code KRX cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K111204 · Streck · Hematology device
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Dec 2011
Decision
237d
Days
Class 2
Risk

K111204 is an FDA 510(k) clearance for the CELL-DYN 22 PLUS CALIBRATOR. 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 December 22, 2011 after a review of 237 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 - K111204

510(k) Number K111204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date December 22, 2011
Days to Decision 237 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
124d slower than avg
Panel avg: 113d · This submission: 237d
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.