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K Number
K993276
Device Name
SIMPLIFY D-DIMER, MODEL DCGK1
Manufacturer
AGEN BIOMEDICAL LTD.
Date Cleared
1999-12-14

(75 days)

Product Code
GHH
Regulation Number
864.7320
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.

Device Description

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma.

AI/ML Overview

While the provided text indicates that the Simplify D-dimer device received 510(k) clearance (K993276) from the FDA, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a clearance letter, stating that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use (aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis, and pulmonary embolism). It outlines regulatory responsibilities and contacts, but does not include the technical details of the performance study that would have supported the substantial equivalence claim.

Therefore, I cannot provide the requested information based solely on the provided input. To answer your questions, I would need access to the actual 510(k) submission summary or other detailed performance study reports for the Simplify D-dimer device.

§ 864.7320 Fibrinogen/fibrin degradation products assay.

(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).