TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

K243858 · Haemonetics Corporation · JPA · Jan 15, 2025 · Hematology

Device Facts

Record IDK243858
Device NameTEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
ApplicantHaemonetics Corporation
Product CodeJPA · Hematology
Decision DateJan 15, 2025
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 864.5425
Device ClassClass 2

Indications for Use

The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. The CRT assay monitors the hemostasis process via both the intrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the TEG 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. The indication for TEG 6s System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.

Device Story

TEG 6s Hemostasis System uses disposable cartridges to analyze 3.2% citrated venous whole blood. Instrument performs automated microfluidic mixing of blood with dried reagents (kaolin, heparinase, tissue factor, abciximab, CaCl2). Detection uses piezoelectric actuator to vibrate measurement cells; optical photodiode monitors meniscus motion. Fast Fourier Transform (FFT) calculates resonant frequency and modulus of elasticity (stiffness) during clot formation and lysis. Output includes numerical parameters (R, K, Alpha, MA, FLEV) and graphical tracings. Used in clinical laboratories or point-of-care settings by healthcare professionals. Clinicians use output to assess coagulopathy, guide transfusion, or monitor heparin effects. Benefits include rapid, semi-quantitative assessment of hemostasis to aid clinical decision-making in surgical/cardiology contexts.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the device modification.

Technological Characteristics

Resonance-based viscoelastic coagulation analysis system. Utilizes disposable assay cartridges (K, KH, RT, FF). System is a multipurpose in vitro coagulation analyzer. Modification pertains to environment of use specifications; no changes to fundamental sensing technology or materials.

Indications for Use

Indicated for use in clinical settings for the evaluation of hemostasis in patients requiring coagulation studies using citrated blood samples.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K243858 B Applicant Haemonetics Corporation C Proprietary and Established Names TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JPA | Class II | 21 CFR 864.5425 - Multipurpose System For In Vitro Coagulation Studies | HE - Hematology | ## II Review Summary: This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable. 1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K150041). 2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} device has not changed. This change was to specify the environment of use for the TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. 4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their pre-amendment) device. K243858 - Page 2 of 2
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