Cleared Traditional

K183160 - TEG 6s Hemostasis System

K183160 is an FDA 510(k) clearance for TEG 6s Hemostasis System, manufactured by Haemonetics Corporation. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K183160 · Haemonetics Corporation · Hematology device
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May 2019
Decision
175d
Days
Class 2
Risk

K183160 is an FDA 510(k) clearance for the TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Haemonetics Corporation (Braintree, US). The FDA issued a Cleared decision on May 9, 2019 after a review of 175 days - an extended review cycle.

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 Haemonetics Corporation devices

FDA 510(k) Submission Details - K183160

510(k) Number K183160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2018
Decision Date May 09, 2019
Days to Decision 175 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
62d slower than avg
Panel avg: 113d · This submission: 175d
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 120
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K183160.
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
K202101 · Accriva Diagnostics, Inc. · Dec 2021
Hemochron Signature Elite
K193041 · Accriva Diagnostics, Inc. · Nov 2019
QNext and DG-PT
K183390 · Diagnostic Grifols, S.A. · Aug 2019
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
K173202 · Sekisui Medical Co., Ltd. · May 2018
ACL AcuStar
K170314 · Instrumentation Laboratory CO · Mar 2017
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
K083518 · Instrumentation Laboratory CO · Mar 2009