Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a turbidimetric assay for D-dimer detection, which is a standard laboratory technique and does not involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.

Therapeutic

No
The device is used for diagnostic purposes (detection of D-dimers as an aid in the diagnosis of VTE), not for treating a condition.

Diagnostic

Yes
The device is described as "an aid in the diagnosis of venous thromboembolism (VTE)".

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical reagent (polystyrene particles coated with an antibody) that undergoes a chemical reaction detected turbidimetrically. This is a hardware-based assay, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide information for diagnosis.
Indications for Use: It's intended "as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]." This clearly indicates a diagnostic purpose.
Device Description: The description details a laboratory test method (turbidimetric detection of aggregation) performed on a sample.
Clinical Study Summary: The inclusion of sensitivity and specificity data from a clinical study further supports its use in a diagnostic context.

All these elements align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

INNOVANCE™ D-Dimer:

For the quantitative determination of cross-linked fibrin degradation products (Ddimers) in human plasma on the Siemens and Sysmex Coagulation Systems. The INNOVANCE™ D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

INNOVANCE™ D-Dimer Controls:

INNOVANCE™ D-Dimer Control 1 and INNOVANCE™ D-Dimer Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Siemens and Sysmex Coagulation Systems.

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

DAP

Device Description

Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggregated when mixed with samples containing D-dimer. The D-dimer crosslinkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to triager an aggregation reaction, which is then detected turbidimetrically via the increase in turbidity.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Method Comparison: Comparative Method: Stratus® CS DDMR, Slope: 0.951, Intercept mg/L FEU: 0.059, Correlation Coefficient: 0.97, n: 318.
In the correlation studies, D-dimer values ranged between 0.18 and 4.39 mg/L FEU.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K063356, K992956

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

510(k) Summary for INNOVANCE™ D-Dimer Assay

OCT 2 4 2008

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

| The assigned 510(k) number is: | September 1 | (
11/6 |
|--------------------------------|-------------|-----------|
| | | |

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

| Manufacturer: | Siemens Healthcare Diagnostics
Products GmbH
Emil-von-Behring Str. 76
D-35001, Marburg Germany |

---------------	---------------------------------------------------------------------------------------------------------

Contact Information: Siemens Healthcare Diagnostics Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date: September 3, 2008

1. Device Name/ Classification: INNOVANCE™ D-Dimer INNOVANCE™ D-Dimer Controls
  Class:

Product Code:

Panel:

Fibrinogen and Fibrin Split Product, Antigen, Antiserum and controls, Class II 21 CFR 864.7320 Hematology (HE) DAP

3. ldentification of the Legally Marketed Device:

Stratus® CS DDMR TestPak, CalPak, DilPak- K063356 Advanced D-Dimer Controls 1 and 2 -- K992956

4. Device Description:

Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggregated when mixed with samples containing D-dimer. The D-dimer crosslinkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to triager an aggregation reaction, which is then detected turbidimetrically via the increase in turbidity.

1

5. Device Intended Use:

INNOVANCE™ D-Dimer:

For the quantitative determination of cross-linked fibrin degradation products (Ddimers) in human plasma on the Siemens and Sysmex Coagulation Systems. The INNOVANCE™ D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

INNOVANCE™ D-Dimer Controls:

INNOVANCE™ D-Dimer Control 1 and INNOVANCE™ D-Dimer Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Siemens and Sysmex Coagulation Systems.

6. Medical device to which equivalence is claimed and comparison information:

The INNOVANCE™ D-Dimer and INNOVANCE™ D-Dimer Controls are substantially equivalent to the Stratus® CS DDMR TestPak, CalPak, DilPak (K063356) and Advanced D-Dimer Controls 1 and 2 (K992956). The INNOVANCE™ D-Dimer method, like the Stratus® D-Dimer method, is intended for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in human plasma and aids in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE).

7. Device Performance Characteristics:

Method Comparison

	Regression Statistics
Comparative Method	Slope	Intercept
mg/L FEU	Correlation
Coefficient	n
Stratus® CS DDMR	0.951	0.059	0.97	318

In the correlation studies, D-dimer values ranged between 0.18 and 4.39 mg/L FEU.

Clinical Study Summary

|

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2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 4 2008

Siemens Healthcare Diagnostics Ms. Kathleen Dray-Lyons 500 GBC Drive M/S 514 Newark, Delaware 19702

Re: K081732

Trade/Device Name: Innovance D-Dimer and Innovance D-Dimer Controls Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: Class II Product Code: DAP Dated: October 16, 2008 Received: October 17, 2008

Dear Ms. Dray-Lyons:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 marketed

3

Page 2 -- Ms. Jepson

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 In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

ia m chan

Maria Chan, Ph.D Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number (if known):

K081737

INNOVANCE™ D-Dimer Device Name:

INNOVANCE™ D-Dimer Controls

Indications For Use:

INNOVANCE™ D-Dimer:

For the quantitative determination of cross-linked fibrin degradation products (Ddimers) in human plasma on the Dade Behring and Sysmex Coaqulation Systems. The INNOVANCE™ D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

INNOVANCE™ D-Dimer Controls:

INNOVANCE™ D-Dimer Control 1 and INNOVANCE™ D-Dimer Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on the Dade Behring and Sysmex Coagulation Systems.

Prescription Use × (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081732