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.

AI/ML Overview

The provided 510(k) summary does not contain acceptance criteria for the device in the traditional sense of performance targets that must be met. Instead, it aims to demonstrate substantial equivalence to a predicate device by showing comparable performance, particularly regarding precision and accuracy, across different usage settings (laboratory vs. point-of-care).

The study described focuses on reproducibility (precision) and correlation (accuracy against the predicate).

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria are not stated. The study aims to demonstrate comparability to the predicate device. The performance is reported in the context of reproducibility and correlation.

Performance Metric	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance
Reproducibility (Precision)	Within-run (WR) SD (%CV) and Total SD (%CV) for two D-dimer levels at various Point-of-Care (POC) sites should be acceptable/comparable to laboratory performance and predicate.	Demonstrated %CVs ranging from 1.7% to 7.4% for WR SD and 2.2% to 9.6% for Total SD across different levels and POC sites.
Correlation (Accuracy)	Slope, Intercept, and Correlation Coefficient between Lab and POC measurements should indicate strong agreement.	Correlation coefficients > 0.989 reported across all POC sites and comparisons (Lab vs. ED, Lab vs. CCU). Slopes were close to 1 (e.g., 0.91 to 1.12) and intercepts were relatively small (e.g., -32.2 to -2.01 ng/mL).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Reproducibility: For each plasma pool level (L1 and L2) at each location (Lab, ED, CCU) within each of the three Point-of-Care sites, the "number of samples tested = 20." This refers to the number of replicates for the precision study, which was "4 reps per day for 5 days."
- Correlation:
  - POC Site 1 (Lab v ED): 64 samples
  - POC Site 1 (Lab v CCU): 62 samples
  - POC Site 2 (Lab v ED): 67 samples
  - POC Site 2 (Lab v CCU): 65 samples
  - POC Site 3 (Lab v ED): 74 samples
  - POC Site 3 (Lab v CCU): 75 samples
Data Provenance: The studies were performed at "three different locations (clinical laboratory (LAB, Emergency Department (ED) and Cardiac Care Unit (CCU) within three external evaluation sites." The document does not explicitly state the country of origin but implies clinical settings. The data appears to be prospective as it involves active testing for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is an in vitro diagnostic test for D-dimer levels, not an imaging or diagnostic AI system requiring expert interpretation of images. Therefore, the concept of "experts used to establish ground truth" as it would apply to imaging studies is not relevant here. The ground truth for D-dimer levels would be the measured values themselves, and the study compares the agreement between measurements obtained in different settings (lab vs. POC) or against a "predicate" device/method.

4. Adjudication Method for the Test Set

Not applicable. As this is not an imaging or qualitative diagnostic study, there is no adjudication process in the traditional sense for establishing ground truth from multiple expert interpretations. The "ground truth" for each sample is its D-dimer concentration as measured by either the laboratory method or the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic test, not an AI-based diagnostic tool requiring human readability or interpretation. The study compares instrument performance in different settings (Lab, ED, CCU) with different operators, but it's not framed as human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this study represents a form of standalone performance evaluation for the device. The device measures D-dimer levels automatically; the "human-in-the-loop" here refers to the operators performing the test, rather than interpreting results that an AI would output. The study specifically addresses performance with "non-laboratory" personnel (ED/CCU) to support point-of-care use, demonstrating the device's robust standalone performance regardless of operator expertise (within trained health care professionals).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of device is the quantitative measurement of D-dimer concentration, typically established by a reference method or the predicate device. The comparison data shows measurements from different operational settings (Lab, ED, CCU) and implicitly compares the new device's derived values to those obtained by the laboratory-based predicate or a standard laboratory setting.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models, as this is a chemical assay, not an AI device. The equivalent of "training" for such an assay would be the internal development and optimization of the assay's reagents and methodology by the manufacturer. The document does not provide details on the sample sizes used during the internal development or validation phase that led to the final product.

9. How the Ground Truth for the Training Set was Established

Given that this is a chemical assay, the concept of "ground truth for a training set" as it relates to AI is not applicable. The assay is based on established biochemical principles and calibrated using known D-dimer concentrations (as mentioned in the "Calibrator" section, where D-dimer in a liquid buffered bovine protein matrix with stabilizers is used). The calibration itself establishes the relationship between the signal detected by the instrument and the D-dimer concentration. This process is part of standard assay development and quality control.

Summary

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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

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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

Calibrator

The Stratus® CS Acute Care™ DDMR calibrator (DDMR CalPak) contains D-dimer in a liquid buffered bovine protein matrix with stabilizers and < 0.1% sodium azide. The DDMR CalPak is a single-use product which contains one calibrator level at an approximate concentration of 3500 ng/mL in each of three wells. The kit consists of five CalPaks at a single calibrator level.

Diluent

The Stratus® CS Acute Care™ DDMR Diluent (DDMR DilPak) contains a liquid buffered boyine protein matrix with stabilizers and < 0.1% sodium azide. The kit consists of 5 DilPaks with diluent in one well.

5. Device Intended Use:

Method

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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.

Calibrator

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.

Diluent

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 D-dimer levels.

6. Medical device to which equivalence is claimed:

Substantial Equivalence:

The products are substantially equivalent to the commercial Dade Behring Stratus® CS DDMR TestPaks, CalPaks and DilPaks.

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

Method

The Stratus® CS Acute Care™ DDMR Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS DDMR TestPak (K022976/K051597). Both assays are in vitro diagnostic tests for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus® CS DDMR method is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]..

There are no formulation or design changes associated with the DDMR TestPak intended use change. The two products are identical and use the same manufacturing processes. Labeling changes reflect the new intended use, supporting data and new name in addition to minor format changes.

Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.

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Calibrator

The Stratus® CS Acute Care™ DDMR calibrator (DDMR CalPak) is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS DDMR CalPak (K022977). Both calibrators are intended to be used to calibrate the DDMR assay.

There are no formulation or design changes associated with the DDMR CalPak name change. The two calibrator products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.

Diluent

The Stratus® CS Acute Care™ DDMR Dil Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS DDMR DilPak (K022976). Both diluents are intended to be used in conjunction with the DDMR TestPaks for the measurement of samples with elevated levels of D-Dimer.

There are no formulation or design changes associated with DDMR DilPak name change. The two diluent products are identical and use the same manufacturing processes. Labeling changes reflect the new name in addition to minor format changes.

Comparison to Predicate Device:

Method comparison and precision analyses were performed at three different locations (clinical laboratory (LAB, Emergency Department (ED) and Cardiac Care Unit (CCU) within three external evaluation sites.

Reproducibility Point of Care Data Subset1,2

Point of Care Site 1
Locations / Level	Mean(ng/mL)[µg/L] FEU	WR SD (%CV)	Total SD (%CV)
Lab - Plasma Pool L1	481.6	12.48 (2.6)	16.12 (3.3)
ED - Plasma Pool L1	526.4	22.06 (4.2)	22.85 (4.3)
CCU - Plasma Pool L1	512.9	36.96 (7.2)	36.96 (7.2)
Lab – Plasma Pool L2	2375.8	122.79 (5.2)	228.13 (9.6)
ED - Plasma Pool L2	2539.9	96.45 (3.8)	114.29 (4.5)
CCU – Plasma Pool L2	2541.0	187.67 (7.4)	187.67 (7.4)

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Locations / Level	Mean(ng/mL)[µg/L] FEU	WR SD (%CV)	Total SD (%CV)
Lab - Plasma Pool L1	502.7	15.86 (3.2)	32.11 (6.4)
ED - Plasma Pool L1	468.0	19.29 (4.1)	23.55 (5.0)
CCU - Plasma Pool L1	482.6	8.40 (1.7)	10.70 (2.2)
Lab - Plasma Pool L2	2433.5	78.51 (3.2)	120.14 (4.9)
ED - Plasma Pool L2	2350.0	105.89 (4.5)	142.73 (6.1)
CCU - Plasma Pool L2	2356.3	140.46 (6.0)	140.46 (6.0)

Point of Care Site 2

Point of Care Site 3

Locations / Level	Mean(ng/mL)[µg/L] FEU	WR SD (%CV)	Total SD (%CV)
Lab – Plasma Pool L1	446.4	10.63 (2.4)	15.94 (3.6)
ED – Plasma Pool L1	484.4	14.80 (3.1)	14.80 (3.1)
CCU - Plasma Pool L1	458.4	16.90 (3.7)	19.72 (4.3)
Lab - Plasma Pool L2	2254.6	86.50 (3.8)	108.48 (4.8)
ED - Plasma Pool L2	2404.4	83.61 (3.5)	94.84 (3.9)
CCU - Plasma Pool L2	2316.7	107.43 (4.6)	107.43 (4.6)

1 Number of samples tested = 20.

2 Point of Care precision data collected and analyzed per NCCLS/CLIS EP15-A: 4 reps per day for 5 days.

POC Site 1	Slope	Interceptng/mL [µg/L]FEU	CorrelationCoefficient	StandardError of theRegression	n
Lab v ED3	1.12 ± 0.01	-8.4 ± 14.3	0.998	78	64
Lab v CCU3	1.09 ± 0.02	-32.2 ± 25.6	0.992	139	62
POC Site 2
Lab v ED4	0.93 ± 0.01	-2.01 ± 16.2	0.996	92	67
Lab v CCU4	0.91 ± 0.02	-28.9 ± 25.2	0.991	140	65
POC Site 3
Lab v ED5	0.99 ± 0.02	-4.62 ± 28.2	0.989	176	74
Lab v CCU5	1.00 ± 0.01	-3.75 ± 22.7	0.994	143	75

Correlation

3 range of results = 36– 4220 ng/mL
4 range of results = 133 – 3974 ng/mL

ge of results = 133 - 3974 ng/mL

5 range of results = 56 – 4778 ng/mL

This data and a summary of information on the operators and their training, from either the ED or CCU, i.e. "non-lab operators supports the use of these products by trained health care professionals in the clinical laboratory and point of care (POC) settings.

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Conclusion:

The products listed in the following table are substantially equivalent based on their indications for use and performance characteristics. Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.

Predicate Device	New Device
Dade Behring Stratus® CS DDMR TestPak(K022976/K051597)	The Stratus® CS Acute Care™ DDMRTestPak
Stratus® CS DDMR CalPak (K022977)	Stratus® CS Acute Care™ DDMR CalPak
Stratus® CS DDMR DilPak (K022976)	Stratus® CS Acute Care™ DDMR DilPak

Pamela A. Jurga Regulatory Affairs and Compliance Manager March 19, 2007

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.

MAR 2 3 2007

_**_, and I am sorry for that.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DADE BEHRING, INC. C/O Pamela A. Jurga P.O. Box 6101 Bldg 500; M.S. 514 Newark, Delaware 19714

Re: K063356

Trade/Device Name: Stratus® Acute Care™ DDMR Test Pak Stratus® Acute Care™ DDMR CalPak Stratus® Acute Care™ DDMR DilPak Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: Class II Product Code: DAP Dated: November 1, 2006 Received: November 7, 2006

Dear Ms. Jurga:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Bockley

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC -

HFZ-404 510(k) Staff HFZ- 440 Division D.O.

and the control of the country of the country

and the comments of the comments of the country of

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Indications for Use

510(k) Number:

K063356

Device Name:

. Stratus® CS Acute Care™ DDMR TestPak
Stratus® CS Acute Care™ DDMR CalPak .
Stratus® CS Acute Care™ DDMR DilPak .

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Dauphine Bautet,

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

10(k) K.063356

Page 1 of 1

Regulation Number and Section

§ 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).