LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

K032611 · Bio-Rad · GGN · Sep 17, 2003 · Hematology

Device Facts

• Record ID: K032611
• Device Name: LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

Device Story

Lyphochek® Coagulation Control Level 4 is a lyophilized human plasma-based quality control material containing added purified biochemicals of animal origin and preservatives. It is used by laboratory personnel to monitor the precision of citrated coagulation systems. The control is reconstituted and analyzed alongside patient samples to verify the performance of coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III), and Thrombin Time (TT). By comparing observed results against established target values, clinicians ensure the accuracy and reliability of coagulation testing, which is critical for diagnosing and managing bleeding or clotting disorders.

Clinical Evidence

Bench testing only. Stability studies confirmed open-vial stability of 24 hours at 2-25°C and a shelf life of three years when stored at 2-8°C.

Technological Characteristics

Lyophilized human plasma matrix; contains purified biochemicals of animal origin and preservatives. Form factor: 1 mL fill size. Storage: 2-8°C. Stability: 24 hours open-vial at 2-25°C. Analyte panel: PT, APTT, Fibrinogen, AT III, TT.

Indications for Use

Indicated for use as a quality control plasma to monitor the precision of citrated coagulation systems 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.

Submission Summary (Full Text)

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**SEP 17 2003**

K032611

Page 1 of 2

Summary of Safety and Effectiveness Lyphochek® Coagulation Control Level 4

#### 1.0 Submitter

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

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

August 11, 2003

## 2.0 Device Identification

| Product Trade Name: | Lyphochek® Coagulation Control Level 4 |
|---------------------|----------------------------------------|
| Common Name: | Plasma Coagulation Control |
| Classifications: | Class II |
| Product Code: | GGN |
| Regulation Number: | 21 CFR 864.5425 |

### 3.0 Device to Which Substantial Equivalence is Claimed

Lyphochek® Coagulation Control Bio-Rad Laboratories Irvine, California

Docket Number: K012722

## 4.0 Description of Device

Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemicals (tissue extract from animal origin), and preservatives. The control is provided in lyophilized form for increased stability.

### 5.0 Statement of Intended Use

Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems

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

The new Lyphochek® Coagulation Control Level 4 claims substantial equivalence to the Lyphochek® Coaqulation Control currently in commercial distribution (K012722). The new Lyphochek® Coagulation Control is a tri-level (Level 1, 2 and 3) product and the current product is a single level (Level 4) product.

| | Bio-Rad | Bio-Rad |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Lyphochek® Coagulation Control | Lyphochek® Coagulation Control |
| | (Predicate Device K012722) | (New Device) |
| Similarities | | |
| Intended Use | Lyphochek® Coagulation Control is intended for<br>use as a quality control plasma control to monitor<br>the precision of citrated coagulation systems. | Lyphochek® Coagulation Control is intended for<br>use as a quality control plasma control to monitor<br>the precision of citrated coagulation systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human plasma |
| Open Vial stability | 24 hours at 2 to 25°C | 24 hours at 2 to 25°C |
| Storage<br>(Unopened) | 2 to 8°C<br>Until expiration date | 2 to 8°C<br>Until expiration date |
| Analytes | Prothrombin Time (PT) Activated Partial Thromboplastin Time (APTT) Fibrinogen Antithrombin II (AT III) Thrombin Time (TT) | Prothrombin Time (PT) Activated Partial Thromboplastin Time (APTT) Fibrinogen Antithrombin II (AT III) Thrombin Time (TT) |
| Fill size | 1 mL | 1 mL |
| Differences | | |
| Formulation | Does not contain constituents of animal origin | Contain constituents of animal origin |
| Levels | Levels 1, 2 and 3 (Does not include level 4) | Level 4 (Does not include levels 1, 2 or 3) |

## 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Coagulation Control Level 4. Product claims are as follows:

- 7.1 Open vial: Once the control material is reconstituted, all analytes will be stable for 24 hours when stored tightly capped at 2-25°C
- 7.2 Shelf Life: Three years when stored at 2-8 °C
- 7.3 Real time studies will be ongoing to support the shelf life of this product.

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 1 7 2003

ood and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k032611 Trade/Device Name: Lyphochek® Coagulation Control Level 4

Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: II Product Code: GGN Dated: August 11, 2003 Received: August 25, 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 (OS) 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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Page 2 -

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): ___________________________________________________________________________________________________________________________________________________

Lyphochek® Coagulation Control Level 4 Device Name:

Indications for Use:

Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

Methods:

- Diagnostica Stago Neoplastine C1 Plus (PT) ●
- Diagnostica Stago PTT Automate .
- Diagnostica Stago Fibrinogen .
- Diagnostica Stago Stachrom (AT III) ●
- Diagnostica Stago Thrombin .
- Axis Shield Nycotest ●
- Axis Shield Cephotest ●

Tugl
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092611

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription use | or |
|------------------|----|
|------------------|----|

Over-the Counter use _________________________________________________________________________________________________________________________________________________________