Cleared Traditional

K161317 - Sysmex Automated Blood Coagulation Analyzer CS-5100

K161317 is an FDA 510(k) clearance for Sysmex Automated Blood Coagulation Anal..., manufactured by Siemens Healthcare Diagnostics Products GmbH. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K161317 · Siemens Healthcare Diagnostics Products GmbH · Hematology device
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Sep 2016
Decision
114d
Days
Class 2
Risk

K161317 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 Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on September 2, 2016 after a review of 114 days - within the typical 510(k) review window.

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. 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 Diagnostics Products GmbH devices

FDA 510(k) Submission Details - K161317

510(k) Number K161317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date September 02, 2016
Days to Decision 114 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
1d slower than avg
Panel avg: 113d · This submission: 114d
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 Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 165
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K161317.
ACL AcuStar
K170314 · Instrumentation Laboratory CO · Mar 2017
Sysmex CS-2100i
K162688 · Siemens Healthcare Diagnostics Products GmbH · Dec 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K162420 · Siemens Healthcare Diagnostics Products GmbH · Dec 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
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · Siemens Healthcare Diagnostic Products GmbH · Jan 2016