Cleared Traditional

K010455 - ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010455 · Diagnostica-Stago · Hematology device
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Jun 2001
Decision
129d
Days
Class 2
Risk

K010455 is an FDA 510(k) clearance for the ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Diagnostica-Stago (Parisppany, US). The FDA issued a Cleared decision on June 7, 2001 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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 devices

Submission Details

510(k) Number K010455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2001
Decision Date June 07, 2001
Days to Decision 129 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 113d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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.