Cleared Traditional

K111822 - STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

K111822 is an FDA 510(k) clearance for STA - LIQUID ANTI-XA, manufactured by Diagnostica Stago, Inc.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K111822 · Diagnostica Stago, Inc. · Hematology device
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Oct 2011
Decision
120d
Days
Class 2
Risk

K111822 is an FDA 510(k) clearance for the STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBP.... Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Diagnostica Stago, Inc. (Rome, IT). The FDA issued a Cleared decision on October 26, 2011 after a review of 120 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, Inc. devices

FDA 510(k) Submission Details - K111822

510(k) Number K111822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2011
Decision Date October 26, 2011
Days to Decision 120 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
7d slower than avg
Panel avg: 113d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KFF Assay, Heparin

All 32
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K111822.
HemosIL Liquid Anti-Xa
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INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
K162540 · Siemens Healthcare Diagnostics Prodcts GmbH · Aug 2017
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · Instrumentation Laboratory CO · Jun 2009
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
K050367 · Hyphen Biomed · May 2006
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · International Technidyne Corp. · Jun 2001
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998