HemosIL D-Dimer HS

K151534 · Instrumentation Laboratory CO · DAP · Jul 6, 2015 · Hematology

Device Facts

• Record ID: K151534
• Device Name: HemosIL D-Dimer HS
• Applicant: Instrumentation Laboratory CO
• Product Code: DAP · Hematology
• Decision Date: Jul 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

The HemosIL D-Dimer HS is an automated latex immunoturbidimetric assay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP family of instruments. The assay is used as an aid in the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Device Story

HemosIL D-Dimer HS is an automated latex-enhanced immunoturbidimetric assay used in clinical laboratories on ACL TOP analyzers. The device utilizes polystyrene latex particles coated with F(ab')2 fragments of monoclonal antibodies specific to the D-Dimer domain. When patient citrated plasma is mixed with the latex reagent and reaction buffer, D-Dimer causes particle agglutination. The analyzer measures the decrease in transmitted light, which is directly proportional to the D-Dimer concentration in the sample. Results are used by clinicians in conjunction with pretest probability (PTP) assessment models to rule out VTE in patients suspected of DVT or PE. The device provides quantitative data to assist in clinical decision-making, potentially reducing the need for unnecessary imaging studies.

Clinical Evidence

No clinical data; bench testing only. Modification involves labeling update based on peer-reviewed literature; no changes to device performance or analytical characteristics.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagent consists of polystyrene latex particles coated with F(ab')2 monoclonal antibody fragments. Analyzers: ACL TOP Family. Sample type: Citrated plasma. Detection limit: 21 ng/mL. Linearity: 150 – 69000 ng/mL. Cut-off: 230 ng/mL.

Indications for Use

Indicated for use as an aid in the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients suspected of having these conditions.

Predicate Devices

• HemosIL D-Dimer HS (K070927)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2015

INSTRUMENTATION LABORATORY CO. NIKITA MALLADI REGULATORY AFFAIRS SPECIALIST 180 HARTWELL ROAD BEDFORD, MA 01730

Re: K151534

Trade/Device Name: HemosIL D-Dimer HS Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: II Product Code: DAP Dated: June 5, 2015 Received: June 8, 2015

Dear Ms. Malladi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

{1}------------------------------------------------

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known)

#### K151534

Device Name HemosIL D-Dimer HS

#### Indications for Use (Describe)

Hemos!L D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE)

For in vitro diagnostic use.

Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Instrumentation Laboratory, a Werfen Company. The logo features a stylized "W" symbol in two shades of blue and green, followed by the company name in a sans-serif font. Below the company name, the text "A Werfen Company" is written in a smaller font size.

## 510(k) Summary

The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

| Submitter's Information | Instrumentation Laboratory (IL) Co.<br>180 Hartwell Road<br>Bedford, MA 01730, USA | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Nikita Malladi, Regulatory Affairs Specialist II<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Preparation Date | June 5, 2015 | |
| Device Trade Name | HemosIL D-Dimer HS | |
| Regulatory Information | Classification: Class II<br>Regulation No.: 21 CFR 864.7320<br>Common Name: Fibrinogen and Fibrin split products, Antigen, Antiserum, Control<br>Panel: Hematology (81)<br>Product Code: DAP | |
| Predicate Device | HemosIL D-Dimer HS 510(k) No.: K070927 | |
| Device Indications for Use /<br>Intended Use | HemosIL D-Dimer HS is an automated latex enhanced immunoassay<br>for the quantitative determination of D-Dimer in human citrated<br>plasma on the ACL TOP for use in conjunction with a clinical pretest<br>probability (PTP) assessment model to exclude venous<br>thromboembolism (VTE) in outpatients suspected of deep venous<br>thrombosis (DVT) and pulmonary embolism (PE)<br><br><i>For in vitro diagnostic use.</i> | |
| Device Description | The D-Dimer HS Latex Reagent is a suspension of polystyrene latex<br>particles of uniform size coated with the F(ab')2 fragment of a<br>monoclonal antibody highly specific for the D-Dimer domain<br>included in fibrin soluble derivatives. The use of the F(ab')2<br>fragment allows a more specific D-Dimer detection avoiding the<br>interference of some endogenous factors like the Rheumatoid<br>Factor. When a plasma containing D-Dimer is mixed with the Latex<br>Reagent and the Reaction Buffer included in the D-Dimer HS kit, the<br>coated latex particles agglutinate. The degree of agglutination is<br>directly proportional to the concentration of D-Dimer in the sample<br>and is determined by measuring the decrease of the transmitted | |

{4}------------------------------------------------

#### Comparison to Predicate:

This Special 510(k) is being submitted to add general information from peer-reviewed published literature to the Summary and Principle section of the HemoslL D-Dimer HS insert sheet regarding the association of patient age with D-Dimer levels.

The submission meets the criteria for a Special 510(k) based on the following:

- No change in indications for use or intended use
- No change in operating principle
- No change to labeled performance claims, including no change to the assay cut-off ●
- . No change to stability claims or to storage instructions
- No change to reagent preparation
- No change to specimen collection and preparation
- No change to formulation or materials
- No change to data reduction software
- No change to test parameters
- No change to calibration
- . No change to quality controls

Following is a description of the similarities and differences between the currently marketed HemosIL D-Dimer HS (K070927) and HemosIL D-Dimer HS with the insert sheet modifications:

| Similarities | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Item | Predicate (K070927) | Modified Device |
| Indications for Use | HemosIL D-Dimer HS is an automated<br>latex enhanced immunoassay for the<br>quantitative determination of D-Dimer<br>in human citrated plasma on the ACL<br>TOP Family for use in conjunction with a<br>clinical pretest probability<br>(PTP)<br>assessment model to exclude venous<br>thromboembolism (VTE) in outpatients<br>suspected of deep venous thrombosis<br>(DVT) and pulmonary embolism (PE). | Same |
| Analyte | D-Dimer | Same |
| Methodology | Latex-enhanced immuoturbidimetric<br>assay | Same |
| Analyzers | ACL TOP Family | Same |
| Sample Type | Citrated Plasma | Same |
| Cut-off | 230 ng/mL | Same |
| Linearity | 150 – 69000 ng/mL | Same |
| Detection Limit | 21 ng/mL | Same |
| Performance Claims | No change to labeled performance claims | Same |

{5}------------------------------------------------

### Comparison to Predicate (Cont.):

| Differences | | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate (K070927) | Modified Device |
| Insert Sheet<br>Summary and Principle<br>Section | Current insert language:<br><br>Elevated levels of D-Dimer are<br>found in clinical conditions suchas deep vein thrombosis (DVT),<br>pulmonary embolism (PE) and<br>disseminated intravascular<br>coagulation (DIC).<br><br>D-Dimer levels also rise during<br>the normal pregnancy, but very<br>high levels are associated with<br>complications. | Insert revisions in <i>italic</i> :<br><br>Elevated levels of D-Dimer are<br>found in clinical conditions such as<br>deep vein thrombosis (DVT),<br>pulmonary embolism (PE) and<br>disseminated intravascular<br>coagulation (DIC).<br><br>D-Dimer levels also rise with age,<br>and during the normal pregnancy,<br>but very high levels are associated<br>with complications.<br><br>Further, age-adjusted cut-off values<br>for DVT and PE suspicion have been<br>shown to increase the specificity of<br>D-Dimer and reduce the number of<br>unnecessary imaging studies in<br>patient populations greater than 50<br>years.<br><br>NOTE: Bibliography in insert<br>updated with applicable<br>supporting references. |

#### Conclusion:

HemosIL D-Dimer HS, with the modified Summary and Principle insert section, is substantially equivalent to the legally marketed predicate device FDA cleared under K070927.