HEMOSIL D-DIMER

K050278 · Instrumentation Laboratory CO · DAP · Mar 10, 2005 · Hematology

Device Facts

• Record ID: K050278
• Device Name: HEMOSIL D-DIMER
• Applicant: Instrumentation Laboratory CO
• Product Code: DAP · Hematology
• Decision Date: Mar 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

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)]. For in vitro diagnostic use.

Device Story

HemosIL D-Dimer is an automated latex-enhanced turbidimetric immunoassay used for quantitative D-Dimer measurement in human citrated plasma. The device utilizes latex particles coated with monoclonal antibodies specific to the D-Dimer domain of fibrin soluble derivatives. When mixed with patient plasma and reaction buffer, the particles agglutinate; the degree of agglutination is directly proportional to D-Dimer concentration. The system measures the decrease in transmitted light through the sample to quantify the agglutination. Used on IL Coagulation Systems in clinical laboratory settings by trained personnel. The output provides a quantitative D-Dimer concentration, which aids clinicians in the diagnostic workup for venous thromboembolism (VTE), including DVT and PE.

Clinical Evidence

Performance data provided for ACL 9000 and ACL TOP systems. Study evaluated 297 (ACL 9000) and 294 (ACL TOP) samples. At a 230 ng/mL cut-off, both systems demonstrated 100% sensitivity (95% CI: 95.2-100% and 95.1-100% respectively) and 100% NPV (95% CI: 95.7-100% and 95.4-100% respectively). Specificity was 38% for ACL 9000 and 36% for ACL TOP.

Technological Characteristics

Latex-enhanced turbidimetric immunoassay. Reagents: polystyrene latex particles coated with mouse monoclonal antibody (MA-8D3), phosphate buffer, bovine serum albumin. Energy source: optical (light transmission measurement). Platform: IL Coagulation Systems (ACL 8000/9000/10000, ACL TOP).

Indications for Use

Indicated for the quantitative determination of D-Dimer in human citrated plasma as an aid in the diagnosis of venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE).

Predicate Devices

• HemosIL D-Dimer (K972696)

Submission Summary (Full Text)

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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 Avenue<br>Lexington, 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:

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)].

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).

### 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<br>(95% CI) | % Specificity<br>(95% CI) | % NPV |
|------------|-----|-----------|---------------------------|---------------------------|----------------------|
| ACL 9000 | 297 | 230 ng/mL | 100%<br>(95.2% - 100%) | 38%<br>(31.4% - 44.6%) | 100%<br>(95.7%-100%) |
| ACL TOP | 294 | 230 ng/mL | 100%<br>(95.1%-100%) | 36%<br>(29.6%-42.6%) | 100%<br>(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 [phone] or [phone] 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)