Cleared Traditional

K053111 - STA-CEPHASCREEN KIT

K053111 is an FDA 510(k) clearance for STA-CEPHASCREEN KIT, manufactured by Diagnostica Stago, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K053111 · Diagnostica Stago, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
May 2006
Decision
181d
Days
Class 2
Risk

K053111 is an FDA 510(k) clearance for the STA-CEPHASCREEN KIT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 181 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 Diagnostica Stago, Inc. devices

FDA 510(k) Submission Details - K053111

510(k) Number K053111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2005
Decision Date May 04, 2006
Days to Decision 181 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
68d slower than avg
Panel avg: 113d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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.

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All 43
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