ADVANCED D-DIMER

K992957 · Dade Behring, Inc. · DAP · Jan 28, 2000 · Hematology

Device Facts

• Record ID: K992957
• Device Name: ADVANCED D-DIMER
• Applicant: Dade Behring, Inc.
• Product Code: DAP · Hematology
• Decision Date: Jan 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with a Dade Behring Coagulation Analyzer.

Device Story

Latex-enhanced turbidimetric assay; uses polystyrene particles covalently linked to monoclonal antibody (DD5) specific to cross-linked fibrin degradation products. Input: human plasma sample. Principle: antibody-antigen agglutination reaction; cross-linked fibrin degradation products trigger agglutination; increase in turbidity measured by Dade Behring Coagulation Analyzer. Output: quantitative D-dimer concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in identifying intravascular coagulation/fibrinolysis and monitoring disseminated intravascular coagulation therapy.

Clinical Evidence

Bench testing only. Correlation study comparing Advanced D-Dimer to Asserachrom® D-Di using 316 samples (range 0.43–85.9 mg/l) yielded correlation coefficient of 0.91, slope 0.98, y-intercept 0.54. Precision evaluated per NCCLS EP5-A: inter-assay precision 0.8–3.8%, intra-assay precision 1.3–3.0%.

Technological Characteristics

Latex-enhanced turbidimetric immunoassay. Reagents: polystyrene particles linked to monoclonal antibody (DD5). Detection: turbidimetric measurement of agglutination. Platform: Dade Behring Coagulation Analyzer.

Indications for Use

Indicated for quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma. Aids in detecting intravascular coagulation and fibrinolysis, and monitoring therapy for disseminated intravascular coagulation.

Predicate Devices

• Asserachrom® D-Di (K862156)

Submission Summary (Full Text)

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K992957

Advanced D-Dimer 510(k) Notification K992957 Additional Information

## 510(k) Summary for Advanced D-Dimer

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _____________________________

#### Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

| Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>Marburg/Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.<br>Glasgow Site<br>P.O. Box 6101<br>Newark, Delaware 19714<br>Attn: Rebecca S. Ayash<br>Tel: [phone] |
| Preparation date: | December 3, 1999 |

#### Device Name/ Classification: 2.

| Advanced D-Dimer: | Fibrinogen/fibrin degradation products assay |
|------------------------|----------------------------------------------|
| Classification Number: | Class II (864.7320) |

#### ldentification of the Legally Marketed Device: 3.

Asserachrom® D-Di (K862156)

#### 4. Device Description:

Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products containing D-dimer are agglutinated when mixed with samples containing D-dimer. The cross-linkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an agglutination reaction, which is then detected turbidimetrically via the increase in turbidity.

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#### 5. Device Intended Use:

Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with a Dade Behring Coagulation Analyzer.

#### Medical device to which equivalence is claimed and comparison information: 6.

There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma. One such product is the Asserachrom® D-Di (K862156). Advanced D-Dimer is substantially equivalent in intended use and results obtained to the Asserachrom® D-Di. The Advanced D-Dimer, like Asserachrom® D-Di is intended to be used for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in human plasma.

#### 7. Device Performance Characteristics:

### Correlation:

The Advanced D-Dimer assay was compared to the Asserachrom® D-Di by evaluating 316 samples ranging from 0.43 to 85.9 mg/l. A correlation coefficient of 0.91 was obtained, with a y-intercept value of 0.54 and a slope of 0.98.

## Precision:

Precision studies were performed by the evaluation of two levels of control material and two levels of human plasma pools in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 0.8 to 3.8%, while the intra-assay precision ranged from 1.3 to 3.0%.

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# JAN 2 8 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Avash Manager, Regulatory Affairs, Biology Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

Re: K992957 Trade Name: Advanced D-Dimer Regulatory Class: II Product Code: DAP Dated: December 3, 1999 Received: December 6, 1999

Dear Ms. Ayash:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulations.

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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 regulation (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" (21CFR 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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Advanced D-Dimer 510(k) Notification K992957 Additional Information

## Indications Statement

Device Name: Advanced D-Dimer

Indications for Use:

Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids 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).

Otto G. Macion

(Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number --

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)