K Number

Device Name

HEMOSIL D-DIMER HS

Manufacturer

INSTRUMENTATION LABORATORY CO.

Date Cleared

2005-04-26

(55 days)

Product Code

DAP HEM

Regulation Number

864.7320

Intended Use

Device Description

HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP as an aid in the diagnosis of venous thromboembolism (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)]. The D-Dimer HS Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab')2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The Use of the F(ab)2 fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latcx Reagent and the Reaction Buffer included in the D-Dimer HS kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K972696

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard automated immunoassay based on latex agglutination and turbidimetry. There is no mention of AI or ML in the device description, performance studies, or key metrics.

Therapeutic

No
This device is an in vitro diagnostic immunoassay used to aid in the diagnosis of venous thromboembolism by measuring D-Dimer levels in plasma. It does not directly treat or prevent a medical condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in the diagnosis of venous thromboembolism (VTE)" and "For in vitro diagnostic use."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical kit containing latex reagents and reaction buffer, which are hardware components used in a turbidimetric immunoassay. The device is an in vitro diagnostic (IVD) test kit, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicitly stated in the Intended Use: The document clearly states "For in vitro diagnostic use."
Measures a substance in a biological sample: The device measures D-Dimer in "human citrated plasma," which is a biological sample.
Used to aid in diagnosis: The intended use is "as an aid in the diagnosis of venous thromboembolism (VTE)."
Performed outside the body: The test is performed on a sample of plasma, not directly on the patient.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DAP

Device Description

The D-Dimer HS Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab')2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The Use of the F(ab)2 fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latcx Reagent and the Reaction Buffer included in the D-Dimer HS kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay).

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)

Precision:
Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results:
ACL TOP:
D-Dimer Plasma Pool: Mean (ng/mL) 179.6, CV% (Within run) 8.3, CV% (Total) 11.0
HemosIL D-Dimer Low Control: Mean (ng/mL) 313.8, CV% (Within run) 3.7, CV% (Total) 7.0
HemosIL D-Dimer High Control: Mean (ng/mL) 677.2, CV% (Within run) 2.0, CV% (Total) 7.0

Method Comparison:
In a method comparison study on an ACL TOP using citrated plasma samples (n=229) ranging in D-Dimer concentration from 87 to 20869 ng/mL, the correlation statistics for HemosIL D-Dimer HS versus the predicate device are shown below:
IL System TOP ACL: Slope 0 0407, Intercept -50.298, and and a concession to manufacturer programment 0.973

Management Study:
An outcome study was performed on 300 frozen samples from patients admitted consecutively to an emergency unit with suspected PE or DVT (frequency of venous thromboembolic disease: 26%). Of the 300 samples, 78 were confirmed as VTE positive (47 PE and 31 DVT) by standard objective tests and the remaining 222 were confirmed as negative.
Instrument ACL TOP: N 300, Cut-off 230 ng/mL

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

% Sensitivity (95% CI): 100% (95.4% to 100%)
% Specificity (95% CI): 47% (40.1% to 53.6%)
% NPV (95% CI): 100% (96.5% to 100%)

Predicate Device(s)

HemosIL D-Dimer K972696

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K050544

APR 2 6 2005 Section 3 HemosIL D-Dimer HS 510(k) Summary (Summary of Safety and Effectiveness)

Applicant Contact Information:

Applicant:	Instrumentation Laboratory Co.
Address:	113 Hartwell Avenue
Lexington, MA 02421
Contact Person:	Carol Marble, Regulatory Affairs Director
Phone Number:	781-861-4467
Fax Number:	781-861-4207
Preparation Date:	February 28, 2005

Device Trade Name:

HemosIL D-Dimer HS

Regulatory Information:

Classification Name: Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control Device Class: Class II 864.7320 Regulation No .: DAP

Product Code: Hematology Panel:

Predicate Device:

HemosIL D-Dimer K972696

Device Intended Use / Description:

Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL D-Dimer HS is substantially equivalent to the commercially available predicate device (HemosIL D-Dimer) in performance and intended use.

Section 3	HemosIL D-Dimer HS 510(k)	Page 1 of
-----------	---------------------------	-----------

Section 3 (Cont.) HemosIL D-Dimer HS 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Precision

Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results:

ACL TOP:	Mean (ng/mL)	CV% (Within run)	CV% (Total)
D-Dimer Plasma Pool	179.6	8.3	11.0
HemosIL D-Dimer Low Control	313.8	3.7	7.0
HemosIL D-Dimer High Control	677.2	2.0	7.0

Method Comparison

In a method comparison study on an ACL TOP using citrated plasma samples (n=229) ranging in D-Dimer concentration from 87 to 20869 ng/mL, the correlation statistics for HemosIL D-Dimer HS versus the predicate device are shown below:

| IL System
.

******************************************************************************************************************************************************************************	Slope	Intercept	and and a concession to manufacturer programment
TOP
ACL	0 0407	-50.298	0.973

Management Study

An outcome study was performed on 300 frozen samples from patients admitted consecutively to an emergency unit with suspected PE or DVT (frequency of venous thromboembolic disease: 26%). Of the 300 samples, 78 were confirmed as VTE positive (47 PE and 31 DVT) by standard objective tests and the remaining 222 were confirmed as negative.

| Instrument | N | Cut-off | % Sensitivity
(95% CI) | % Specificity
(95% CI) | % NPV
(95% CI) |
|------------|-----|-----------|---------------------------|---------------------------|-------------------------|
| ACL TOP | 300 | 230 ng/mL | 100%
(95.4% to 100%) | 47%
(40.1% to 53.6%) | 100%
(96.5% to 100%) |

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, suggesting a sense of community and support.

APR 2 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

Re: K050544

Trade/Device Name: HemosIL D-Dimer HS Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control Regulatory Class: II Product Code: DAP Dated: February 28, 2005 Received: March 2, 2005

Dear Mr. Marble:

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

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerf

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

Indications for Use

510(k) Number (if known): K050544

Device Name: HemosL D-Dimer HS

Indications for Use:

For in vitro diagnostic use.

Prescription Use ﺮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050544

HemosIL D-Dimer HS 510(k)