Cleared Traditional

K150678 - Sysmex Automated Blood Coagulation Analyzer CS-5100

K150678 is an FDA 510(k) clearance for Sysmex Automated Blood Coagulation Anal..., manufactured by Siemens Healthcare Diagnostic Products GmbH. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K150678 · Siemens Healthcare Diagnostic Products GmbH · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
301d
Days
Class 2
Risk

K150678 is an FDA 510(k) clearance for the Sysmex Automated Blood Coagulation Analyzer CS-5100. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on January 11, 2016 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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. Elevated predicate reliance profile. 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 - K150678

510(k) Number K150678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2015
Decision Date January 11, 2016
Days to Decision 301 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
188d slower than avg
Panel avg: 113d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Consultant

Siemens Healthcare Disgnostics Products GmbH
DONNA NOEH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 164
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K150678.
Sysmex Automated Blood Coagulation Analyzer CS-5100
K161317 · Siemens Healthcare Diagnostics Products GmbH · Sep 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K161312 · Siemens Healthcare Diagnostics Products GmbH · Sep 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K151259 · Siemens Healthcare Diagnostics Products GmbH · Jan 2016
STA R MAX
K151867 · Diagnostica Stago S.A.S · Aug 2015
CORA (Coagulation Resonance Analysis) System
K150041 · Coramed Technologies, LLC · Jun 2015
STA COMPACT MAX
K130090 · Diagnostica Stago, Incorporated · Feb 2013