LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3

K032017 · Bio-Rad · GGN · Aug 8, 2003 · Hematology

Device Facts

• Record ID: K032017
• Device Name: LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.

Device Story

Liquichek™ D-dimer Control is a liquid quality control product derived from processed human plasma with added constituents of human/animal origin and preservatives. It is used in clinical laboratory settings to monitor the precision of D-dimer testing procedures. The control is processed by laboratory technicians on specific coagulation analyzers (e.g., Vidas, Stratus CS, Sysmex, LIATEST, ACL, Tina-quant). By comparing the measured values of the control against established means and ranges, clinicians verify the performance and reliability of the analytical test methods. This monitoring ensures the accuracy of patient D-dimer results, which are critical for clinical decision-making regarding coagulation disorders.

Clinical Evidence

No clinical data. The device is an in vitro diagnostic quality control product; substantial equivalence is supported by bench testing, including stability studies (open vial and shelf life) and comparison of analyte levels against the predicate device.

Technological Characteristics

Liquid-form quality control consisting of processed human plasma with added human/animal constituents and preservatives. Tri-level formulation (Levels 1, 2, and 3). Storage requirements: 2°C to 8°C (unopened); 2°C to 25°C (opened).

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer in clinical laboratory settings.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Liquichek™ D-dimer Control (K030182)

Submission Summary (Full Text)

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**AUG - 8 2003**

K032017

Page 1 of 2

# Summary of Safety and Effectiveness Liquichek™ D-dimer Control

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] [phone] Fax:

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

June 26, 2003

### 2.0 Device Identification

| Product Trade Name: | Liquichek™ D-dimer Control |
|---------------------|-----------------------------|
| Common Name: | Plasma, Coagulation Control |
| Classifications: | Class II |
| Product Code: | GGN |
| Regulation Number: | CFR 862.5425 |

### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek™ D-dimer Control Bio-Rad Laboratories Irvine, California

510(k) Number: K030182

#### 4.0 Description of Device

Liquichek™ D-dimer Control is prepared from processed human plasma with added constituents of human and animal origin, and preservatives. The control is provided in liquid form for convenience.

#### 5.0 Statement of Intended Use

Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.

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### 6.0 Comparison of the new device with the Predicate Device

The new Liquichek™ D-dimer Control claims substantial equivalence to the Liquichek™ D-dimer Control currently in commercial distribution (K030182). The new Liquichek™ Ddimer Control is a tri-level (Level 1, 2 and 3) product and the current product is a bi-level (Level 1 and 2) product.

| | Bio-Rad | Bio-Rad |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Liquichek™ D-dimer Control | Liquichek™ D-dimer Control |
| | (New Device) | (Predicate Device K030182) |
| Similarities | | |
| Intended Use | Liquichek D-dimer Control is intended for use<br>as a quality control to monitor the precision of<br>D-dimer procedures. | Liquichek D-dimer Control is intended for use<br>as a quality control to monitor the precision of<br>D-dimer procedures. |
| Analytes | D-dimer | D-dimer |
| Storage<br>(Unopened) | 2°C to 8°C<br>Until expiration date | 2°C to 8°C<br>Until expiration date |
| Matrix | Processed human plasma with added<br>constituents of human and animal origin, and<br>preservatives. | Processed human plasma with added<br>constituents of human and animal origin, and<br>preservatives. |
| Open Vial Claim | 30 days at 2 to 25°C | 30 days at 2 to 25°C |
| Form | Liquid | Liquid |
| Differences | | |
| Levels | Level 1, 2 and 3 | Level 1 and 2 (Does not have a Level 3<br>product) |
| Analyte D-dimer<br>Levels | Level 3: 4.5 - 5.5 ug FEU/mL | Level 1: 0.22 - 0.4 ug FEU/mL |
| | | Level 2: 1.5 - 2.5 ug FEU/mL |

Table 1. Similarities and Differences between new and predicate device.

#### 7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ D-dimer Control. Product claims are as follows:

- 7.1 Open vial: Once the product is opened, the analyte will be stable for 30 days when stored tightly capped at 2 to 25°C.
- 7.2 Shelf Life: Three years when stored at 2 to 8 °C.

Real time studies will be onqoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT FOR HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 8 2003

Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017

Re: k032017 Trade/Device Name: Liquichek™M D-dimer Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: June 26, 2003 Received: July 1, 2003

Dear Ms. Zeballos:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known):

Liquichek™ D-dimer Control Device Name:

Indications for Use:

Liquichek D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.

# Methods:

- bioMerieux Vidas .
- Dade Behring BCS/BCT Advanced D-Dimer ●
- Dade Behring Stratus CS ●
- Dade Behring Sysmex Series Advanced D-Dimer ●
- Diagnostica Stago Sta/Sta-R/Sta-Compact LIATEST ●
- IL ACL Series ●
- Roche Cobas Integra 400/800 Tina-quant .
- Roche Hitachi Tina-quant .

510(k)

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription use | <div style="display:inline-block;">✓</div> | or | Over-the Counter use |
|------------------|--------------------------------------------|----|----------------------|
|------------------|--------------------------------------------|----|----------------------|

Saitte Y. Michael O MD FOR J. BAUTISTA

Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032017