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K Number
K030687
Device Name
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
2003-06-27

(114 days)

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

The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.

The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay.

For in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

I am sorry. This document is a letter from the FDA regarding the 510(k) premarket notification for the K-Assay D-Dimer Immunoturbidimetric Assay and Calibrator. It primarily discusses regulatory classification and approval to market the device.

Based on the provided text, there is no information available about the acceptance criteria or a study proving the device meets acceptance criteria.

The document details the following:

  • Device Name: K-Assay® D-Dimer Immunoturbidimetric Assay and K-Assay® D-Dimer Immunoturbidimetric Calibrator
  • Regulation Number: 21 CFR 864.7320
  • Regulation Name: Fibrinogen/fibrin degradation products assay
  • Regulatory Class: Class II
  • Product Code: DAP: GHH
  • Indications For Use: The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay. The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay. For in vitro diagnostic use.

To answer your request, I would need a different document that describes the performance study details for this specific 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).