Cleared Traditional

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (K183160) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183160 · Haemonetics Corporation · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 77
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