Cleared Traditional

K242952 - INNOVANCE Antithrombin

K242952 is an FDA 510(k) clearance for INNOVANCE Antithrombin, manufactured by Siemens Healthcare Diagnostic Products GmbH. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K242952 · Siemens Healthcare Diagnostic Products GmbH · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K242952

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.

JBQ Device Classification - Class 2, Special Controls

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

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 45
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K242952.
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · Siemens Healthcare Diagnostics · May 2009
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
HEMOSIL LIQUID ANTITHROMBIN
K062431 · Instrumentation Laboratory CO · Sep 2006
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · Instrumentation Laboratory CO · Jan 2004
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · Instrumentation Laboratory CO · Aug 2002
COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002