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K Number
K063356
Device Name
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
Manufacturer
DADE BEHRING, INC.
Date Cleared
2007-03-23

(136 days)

Product Code
DAP
Regulation Number
864.7320
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stratus® CS Acute Care™ D-dimer (DDMR) method is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus® CS Acute Care™ DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute Care™ D-dimer Calibrator (DDMR CalPak) Catalog, No. CDDMR-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Ddimer (DDMR) method. The Stratus® CS Acute Care™ D-dimer Dilution Pak (DDMR DilPak), Catalog. No. CDDMR-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ DDMR TestPak, Catalog. No. CDDMR for the measurement of samples with elevated levels of D-Dimer.
Device Description
The Stratus® CS Acute Care™ DDMR procedure is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate, consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the DDMR molecule is pipetted onto the reaction zone of the paper. Durine this second incubation period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibody-antigen-labeled antibody sandwich. The unbound, labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution, to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of the enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of D-dimer in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
More Information

K022976/K051597, K022977

Not Found

No
The device description details a standard immunoassay technology with optical measurement and microprocessor-based data analysis. There is no mention of AI or ML algorithms for data interpretation or decision support.

No
The device is described as an "in vitro diagnostic product" intended for the "quantitative measurement of cross-linked fibrin degradation products (D-dimer)" as an aid in diagnosing venous thromboembolism. It does not actively treat or directly manage a patient's condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that "The Stratus® CS Acute Care™ D-dimer (DDMR) method is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma." and "The Stratus® CS Acute Care™ DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]."

No

The device description clearly outlines a hardware-based immunoassay procedure involving physical components like glass fiber paper, antibodies, enzymes, and an optical system for measurement. While a microprocessor performs data analysis, the core functionality relies on physical and chemical reactions within a dedicated analyzer.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The document explicitly states that the Stratus® CS Acute Care™ D-dimer method, Calibrator, and Dilution Pak are "in vitro diagnostic test[s]" and "in vitro diagnostic product[s]".
  • Purpose: The intended use is for the quantitative measurement of D-dimer in human plasma as an aid in the diagnosis of venous thromboembolism (VTE). This is a diagnostic purpose performed outside of the body (in vitro).
  • Device Description: The description details a laboratory-based assay procedure using biological samples (plasma) and reagents to measure a specific analyte (D-dimer).

The information provided clearly aligns with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Stratus® CS Acute Care™ D-dimer (DDMR) method is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus® CS Acute Care™ DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.

The Stratus® CS Acute Care™ D-dimer Calibrator (DDMR CalPak) Catalog, No. CDDMR-C, is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Ddimer (DDMR) method.

The Stratus® CS Acute Care™ D-dimer Dilution Pak (DDMR DilPak), Catalog. No. CDDMR-D, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ DDMR TestPak, Catalog. No. CDDMR for the measurement of samples with elevated levels of D-Dimer.

Product codes (comma separated list FDA assigned to the subject device)

DAP

Device Description

Method

The Stratus® CS Acute Care™ DDMR procedure is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate, consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the DDMR molecule is pipetted onto the reaction zone of the paper. Durine this second incubation period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibody-antigen-labeled antibody sandwich. The unbound, labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution, to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of the enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of D-dimer in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.

Calibrator

The Stratus® CS Acute Care™ DDMR calibrator (DDMR CalPak) contains D-dimer in a liquid buffered bovine protein matrix with stabilizers and

§ 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).

0

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K063356

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Manufacturer: Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Pamela A. Jurga Tel: 302-631-8891 Date of Preparation: March 19, 2007

2. Device Name / Classification

  • . Stratus® CS Acute Care™ D-dimer (DDMR) TestPak / Class II
  • Stratus® CS Acute Care™ D-dimer (DDMR) CalPak (the assay calibrator) / ● Class II
  • Stratus® CS Acute Care™ D-dimer (DDMR) DilPak (the assay diluent)/ Class II .

Classification Name:

  • Fibrinogen/fibrin degradation products test systems and associated . calibrator and diluent
    Common/Usual Name:

  • D-dimer assay and calibrator and diluent .
    Proprietary Name:

  • Stratus® CS Acute Care™ D-dimer (DDMR) TestPak .

  • Stratus® CS Acute Care™ D-dimer (DDMR) CalPak ●

  • . Stratus® CS Acute Care™ D-dimer (DDMR) DilPak

3. Identification of the Predicate Device

1

  • Dade Behring Stratus® CS DDMR TestPak and DilPak . K022976/K051597
  • . Dade Behring Stratus® CS DDMR CalPak K022977

FDA Guidance Document(s):

  • . "Bundling Multiple Devices or Multiple Indications in a Single Submission" - 11/26/2003

4. Device Description(s):

Method

The Stratus® CS Acute Care™ DDMR procedure is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate, consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the DDMR molecule is pipetted onto the reaction zone of the paper. Durine this second incubation period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibody-antigen-labeled antibody sandwich. The unbound, labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution, to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of the enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of D-dimer in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.

Calibrator

The Stratus® CS Acute Care™ DDMR calibrator (DDMR CalPak) contains D-dimer in a liquid buffered bovine protein matrix with stabilizers and