Cleared Traditional

K242952 - INNOVANCE Antithrombin (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence.

K242952 · Siemens Healthcare Diagnostic Products GmbH · Hematology device
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Mar 2025
Decision
184d
Days
Class 2
Risk

K242952 is an FDA 510(k) clearance for the INNOVANCE Antithrombin. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on March 28, 2025 after a review of 184 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - 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 Siemens Healthcare Diagnostic Products GmbH devices

Submission Details

510(k) Number K242952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2024
Decision Date March 28, 2025
Days to Decision 184 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
71d slower than avg
Panel avg: 113d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Hematology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03754790 Active not recruiting Interventional Industry-sponsored

Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

281
Patients (actual)
79
Sites
Treatment
Purpose
Open label
Masking
Condition studied Hemophilia
Study design Single group
Eligibility Male only · 12 Years+
Principal investigator Clinical Sciences & Operations
Sponsor Genzyme, a Sanofi Company (industry)
Started 2019-01-09 → Primary completion 2026-11-05
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs)
Secondary outcome
Annualized bleeding rate (ABR)
View full study on ClinicalTrials.gov