IL TEST D-DIMER

K972696 · Instrumentation Laboratory CO · DAP · Nov 4, 1997 · Hematology

Device Facts

• Record ID: K972696
• Device Name: IL TEST D-DIMER
• Applicant: Instrumentation Laboratory CO
• Product Code: DAP · Hematology
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ 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 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).

Device Story

IL Test™ D-Dimer is an in vitro diagnostic assay for human plasma; utilizes latex particles coated with monoclonal antibodies specific to D-Dimer domain of fibrin soluble derivatives. Principle of operation: turbidimetric immunoassay; plasma sample mixed with latex reagent and reaction buffer; agglutination occurs proportional to D-Dimer concentration; decrease in transmitted light measured by instrument (ACL 6000/ACL Futura). Used in clinical laboratory settings by trained personnel. Output is quantitative D-Dimer concentration; assists clinicians in assessing fibrinolysis/coagulation status.

Clinical Evidence

Method comparison study of 105 plasma samples; correlation (r) of 0.998 against predicate on ACL 6000 and ACL systems. Precision testing on ACL 6000 showed CVs of 4.4%, 2.4%, and 2.2% at mean concentrations of 390, 888, and 1055 ng/mL respectively. Precision testing on ACL Futura showed CVs of 6.9%, 2.1%, and 2.7% at mean concentrations of 411, 912, and 1051 ng/mL respectively.

Technological Characteristics

Turbidimetric immunoassay; latex particles coated with monoclonal antibodies. Quantitative measurement via light transmission decrease. System requires specific instrumentation (ACL series).

Indications for Use

Indicated for the quantitative in vitro diagnostic determination of D-Dimer in human plasma to aid in the detection of fibrin degradation products.

Predicate Devices

• AGEN's Dimertest® Gold EIA Kit (K945642)

Submission Summary (Full Text)

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K972696

# SECTION 3 IL Test™ D-Dimer - 510(k) SUMMARY (Summary of Safety and Effectiveness)

### Submitted by:

Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax: --

### Contact Persons:

Betty Lane Phone: [phone]

Carol Marble Alternate: Phone: [phone]

Summary Prepared:

July 9, 1997

#### Name of the device:

IL Test™ D-Dimer

### Classification name(s):

| 864.7320 | Fibrinogen/fibrin degradation products assay | Class II |
|----------|-------------------------------------------------------------------|----------|
| 81 DAP | Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control | |

### Identification of predicate device(s):

AGEN's Dimertest® Gold EIA Kit K945642

### Description of the device/intended use(s):

IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin When plasma containing D-Dimer is mixed with the D-Dimer Latex soluble derivatives. Reagent and Reaction Buffer, 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).

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:

IL Test™ D-Dimer is a quantitative D-Dimer test like the predicate Dimertest® Gold EIA Kit and is substantially equivalent in performance, intended use, and safety and effectiveness.

## Summary of Performance Data:

In a method comparison study evaluating 105 plasma samples, the correlation (r) of IL Test™ D-Dimer to the predicate device was 0.998 on both the ACL 6000 and on the ACL. On the ACL 6000, within precision accessed over multiple runs gave a CV of 4.4% (at a mean of 390 ng/mL), 2.4% (at a mean of 888 ng/mL) and 2.2% (at a mean of 1055 ng/mL). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 6.9% (at a mean of 411 ng/mL), 2.1% (at a mean of 912 ng/mL) and 2.7% (at a mean of 1051 ng/mL).

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NOV - 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Betty Lane ---------Director of Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173

Re : K972696/S1 Trade Name: IL Test™ D-Dimer Product Code: DAP Requlatory Class: II GHH II September 8, 1997 Dated: Received: September 9, 1997

Dear Ms. Lane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: IL Test™ D-Dimer

# Indications for Use:

IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ 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 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).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972696 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

Section 2

IL Test™ D-Dimer 510(k)