CONTROL PLASMA P

K023312 · Dade Behring, Inc. · GGC · Nov 1, 2002 · Hematology

Device Facts

• Record ID: K023312
• Device Name: CONTROL PLASMA P
• Applicant: Dade Behring, Inc.
• Product Code: GGC · Hematology
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Fibrinogen (Clauss method); Coagulation factors II, V, VII, VIII, VWf, IX, X, XI, XII and XIII*; Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C, inhibitor*; Total complement activity*, Plasminogen. (* Not available in the U.S.)

Device Story

Control Plasma P is a lyophilized, assayed quality control material derived from pooled human plasma; stabilized with HEPES buffer. It is used in clinical laboratories to monitor the accuracy and precision of coagulation and fibrinolysis assays. The control is reconstituted and analyzed alongside patient samples using mechanical or photo-optical coagulation systems. By comparing the measured values of the control against assigned target values in the pathological range, clinicians verify the performance of their testing systems. This ensures the reliability of diagnostic results for coagulation factors and inhibitors, supporting clinical decision-making regarding patient hemostasis and fibrinolysis status.

Clinical Evidence

Bench testing only. Stability studies demonstrated that reconstituted Control Plasma P recovers within assigned values for 4 hours at +15 to +25°C, 4 weeks at -20°C, and 2 hours after thawing at +15 to +25°C following 4 weeks of frozen storage.

Technological Characteristics

Lyophilized pooled human plasma; stabilized with HEPES buffer. Formulated for use as an assayed control in the pathological range. Compatible with mechanical and photo-optical coagulation systems. No electronic components or software algorithms.

Indications for Use

Indicated for use as an accuracy control for coagulation and fibrinolysis tests in the pathological range. Intended for professional use in clinical laboratory settings to monitor the accuracy and precision of coagulation testing systems.

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

• Control Plasma P (K924405)

Reference Devices

• Control Plasma N (K023309)

Submission Summary (Full Text)

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Dade Behring Inc.
- Control Plasma P
510(k) Modification

1623312

1 2002 NOV

# ATTACHMENT 5

# 510(k) Summary

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### 510(k) Summary Control Plasma P

### 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of 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: Donna Wolf<br>Tel: [phone] |
| Preparation date: | October 2, 2002 |

#### 2. Device Name/ Classification:

Control Plasma P / Multipurpose system for in vitro coagulation studies. Class II (864.5425)

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

Control Piasma P (K924405)

#### 4. Device Description:

Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological ranqe.

#### 5. Device Intended Use:

Assayed for use as an accuracy control of the following parameters in the pathological range:

Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Fibrinogen (Clauss method); Coagulation factors II, V, VII, VIII, VWf, IX, X, XI, XII and XIII*; Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C, inhibitor*; Total complement activity*, Plasminogen. (* Not available in the U.S.)

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

Control Plasma P (modified) is substantially equivalent in intended use to the Control Plasma P (K924405) currently marketed. Control Plasma P (modified), like the current Control Plasma P is intended for use as an assayed quality control material to monitor the accuracy and precision of various coagulation and fibrinolysis tests in the pathological range using a variety of mechanical and photo-optical coagulation systems.

#### 7. Device Performance Characteristics:

### Stability:

In duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values for the following claims: 4 hours at +15 to +25°C; 4 weeks at -20; 2 hours after thawing at +15 to +25°C (stored for 4 weeks at -20 to -30°C).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and head, symbolizing health and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna A. Wolf Senior Regulatory Affairs Specialist Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: k023312 Trade/Device Name: Control Plasma P Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GGC Dated: October 2, 2002 Received: October 3, 2002

Dear Ms. Wolf:

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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Control Plasma N. KC23309

## Indications for Use Statement

Device Name:

Control Plasma P

### Indications for Use:

Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range:

- Prothrombin time (PT) ﮩﮯ
- Activated partial thromboplastin time (aPTT) 2.
- 3. Fibrinogen (Clauss method)
- Coagulation factors il, V, Vii, Vili, VWF, iX, X, XI, and Xii 4 .
- Inhibitors: Antithrombin III, protein C, protein S, α2-antiplasmin ട.
- Plasminogen 6.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) ORH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Clinical Laboratory Devices

**510(k) Number**

Prescription Use (Per 21 CFR 801.109)

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