HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems as an aid in the diagnosis of venous thromboembolism (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)].

Device Description

The D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin soluble derivatives. When plasma containing D-Dimer is mixed with the D-Dimer Latex Reagent and Reaction Buffer, the coated latex particles agelutinate. 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).

AI/ML Overview

The HemosIL D-Dimer device is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems as an aid in the diagnosis of venous thromboembolism (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)].

Here's a breakdown of its acceptance criteria and the study that proves it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses sensitivity and Negative Predictive Value (NPV) as key performance metrics, with a required sensitivity of 100% and NPV of 100% at a specific cut-off.

Instrument	N	Cut-off	Acceptance Criteria (Implied Minimum)	Reported Device Performance (Sensitivity)	Reported Device Performance (NPV)
ACL 9000	297	230 ng/mL	100% Sensitivity, 100% NPV	100% (95.2% - 100% CI)	100% (95.7%-100% CI)
ACL TOP	294	230 ng/mL	100% Sensitivity, 100% NPV	100% (95.1%-100% CI)	100% (95.4%-100% CI)

Note: While specificity is reported, the context of D-Dimer as a rule-out test for VTE typically prioritizes very high sensitivity and NPV, suggesting these are the primary implicit acceptance criteria for confirming its utility as an "aid in diagnosis" by ruling out the condition.

2. Sample Sizes Used for the Test Set and Data Provenance:

ACL 9000 Test Set Sample Size: 297
ACL TOP Test Set Sample Size: 294
Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, whether retrospective or prospective).

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

This information is not provided in the given summary. The document does not specify how the DVT/PE diagnoses (the ground truth for VTE) were established, nor does it mention the number or qualifications of experts involved.

4. Adjudication Method for the Test Set:

This information is not provided in the given summary. There is no mention of an adjudication process for resolving discrepancies in ground truth determination.

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

No. The study described is a standalone performance evaluation of the HemosIL D-Dimer device against a clinical outcome, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes. The reported performance metrics (Sensitivity, Specificity, NPV) are for the HemosIL D-Dimer device acting as an automated assay by itself, without explicit human intervention in interpreting the D-Dimer result beyond the established cut-off. The device determines the D-Dimer concentration, and this concentration is then used with a pre-defined cut-off to aid in diagnosis.

7. The Type of Ground Truth Used:

The ground truth used is the diagnosis of venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). This implies clinical diagnosis, likely established through standard diagnostic imaging (e.g., ultrasound for DVT, CT pulmonary angiography for PE) and clinical assessment, though the specifics are not detailed.

8. The Sample Size for the Training Set:

The provided text does not include information about a training set or its sample size. The focus is on the performance of the device on a validation or test set. As this is an immunoassay, the concept of a "training set" in the context of machine learning for image analysis might not directly apply here; instead, the assay's development would involve reagent optimization and calibration.

9. How the Ground Truth for the Training Set Was Established:

Since there is no mention of a training set, this information is not applicable/provided in the document.

Summary

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K050278

হ

MAR 1 0 2005

Section 3 HemosIL D-Dimer

510(k) Summary (Summary of Safety and Effectiveness)

Applicant Contact Information:

Applicant:	Instrumentation Laboratory Co.
Address:	113 Hartwell AvenueLexington, MA 02421
Contact Person:	Carol Marble, Regulatory Affairs Director
Phone Number:	781-861-4467
Fax Number:	781-861-4207
Preparation Date:	February 4, 2005

Device Trade Name:

HemosIL D-Dimer

Regulatory Information:

Classification Name: Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control

Device Class:	Class II
Regulation No.:	864.7320
Product Code:	DAP
Panel:	Hematology

Predicate Device:

HemosIL D-Dimer K972696

Device Indications for Use/Description:

Technological Characteristic Summary:

HemosIL D-Dimer is identical to the predicate device except for the clarifications for use and the introduction of additional performance data in the product labeling.

Instrument	N	Cut-off	% Sensitivity(95% CI)	% Specificity(95% CI)	% NPV
ACL 9000	297	230 ng/mL	100%(95.2% - 100%)	38%(31.4% - 44.6%)	100%(95.7%-100%)
ACL TOP	294	230 ng/mL	100%(95.1%-100%)	36%(29.6%-42.6%)	100%(95.4%-100%)

Performance Data Summary:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol is a stylized representation of an eagle with three wave-like lines emanating from its head, symbolizing health and human services.

MAR 1 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421

K050278 Re: Trade/Device Name: HemosIL D-Dimer Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Product Assay Regulatory Class: II Product Code: DAP Dated: February 4, 2005 Received: February 7, 2005

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrebare) 76 ttg enactment date of the Medical Device Amendments, or to conninered pror to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices mat have been rechassinou in asse approval of a premarket approval application (PMA). and Cosmette 7 for (110) that as nevice, subject to the general controls provisions of the Act. The r ou may, dicrorere, mains 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 r your device is elassinod (over as 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 I Toase oc advisod that I Dr a retiren that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any i cacial stutures and regeranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CTN Part 8075, adoming (DF CFR Crains (QS) regulation (21 CFR Part 820). This letter requirements as bet form in are quanded as described in your Section 510(k) premarket will anow you to begin mation.org your antial equivalence of your device to a legally marketed nonfreation. The results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, of In If you desire specific information acount in the office , please contact the Office of In
or questions on the promotion and advertises of your and any of 0.0.0.0184. Also, ma of questions on the promotion and advertising or your be may be and the Vitro Diagnostic Device Lyaniation and Barey as (21)Expands (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the Ast from the You may obtain other general information on your responsibilities under the Act from the You may outain other general mornational on your copyisumer 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 Beckerh

Robert L. Becker, Jr., MD, PA 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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Indications for Use

510(k) Number (if known): K050278

Device Name: HemosIL D-Dimer

Indications for Use:

HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative Hemosil - D-Dimer in human citrated plasma on IL Coagulation Systems an aid in the delerinmation of D-Dimer in namal enable (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)].

For in vitro diagnostic use.

Prescription Use _ (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) K050278

HemosIL D-Dimer 510(k)

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).