CONTROL PLASMA N AND CONTROL PLASMA P

K042209 · Dade Behring, Inc. · GGN · Oct 21, 2004 · Hematology

Device Facts

• Record ID: K042209
• Device Name: CONTROL PLASMA N AND CONTROL PLASMA P
• Applicant: Dade Behring, Inc.
• Product Code: GGN · Hematology
• Decision Date: Oct 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Control Plasma N is an assayed control for use in monitoring the performance of the following parameters in the normal range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Thrombin time (TT) 4. Batroxobin time 5. Fibrinogen 6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII 7. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin 8. Plasminogen 9. Lupus anticoagulants. Control Plasma P is an assayed control for use in monitoring the performance of the following parameters in the pathological range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (aPTT) 3. Fibrinogen (Clauss method) 4. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII 5. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin 6. Plasminogen.

Device Story

Control Plasma N and P are lyophilized, human-plasma-derived controls used in clinical laboratories to monitor the performance of coagulation assays. Control Plasma N is pooled human plasma stabilized with HEPES buffer for normal range monitoring; Control Plasma P is pooled human plasma adjusted to defined factor concentrations and stabilized with HEPES for pathological range monitoring. These controls are used by laboratory technicians to verify the accuracy and precision of coagulation testing systems. By comparing observed results against the assayed values provided for the controls, clinicians ensure the reliability of patient test results for parameters including PT, aPTT, fibrinogen, and various coagulation factors. This quality control process helps maintain the integrity of clinical decision-making regarding patient coagulation status.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated using retrospective data from 68 lots (Control Plasma N) and 54 lots (Control Plasma P). Control Plasma N precision: 2.1–4.5% CV. Control Plasma P precision: 3.0–8.1% CV.

Technological Characteristics

Pooled human plasma; HEPES buffer stabilizer; lyophilized form; siliconized vials. Compatible with mechanical and photo-optical coagulation instrumentation. Traceable to WHO reference preparations and in-house standards.

Indications for Use

Indicated for use as an assayed control to monitor the performance of coagulation assays in normal (Control Plasma N) and pathological (Control Plasma P) ranges for patients undergoing coagulation testing.

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

• Dade Behring Control Plasma N (K023309)
• Dade Behring Control Plasma P (K023312)

Submission Summary (Full Text)

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K042209

# 510(k) Summary Control Plasma N and P

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

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Donna Wolf Tel: [phone]

August 13, 2004 Preparation date:

### 2. Device Name/ Classification:

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

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

Control Plasma N (K023309) and Control Plasma P (K023312)

### Device Description: 4.

Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution.

### Device Intended Use: 5.

Control Plasma N is an assayed control for use in monitoring the performance of the following parameters in the normal range:

- 1. Prothrombin time (PT)
- 2. Activated partial thromboplastin time (APTT)
- 3. Thrombin time (TT)
- 4. Batroxobin time
- 5. Fibrinogen
- 6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
- 7. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
- 8. Plasminogen
- 9. Lupus anticoaquiants

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

- 1. Prothrombin time (PT)
- 2. Activated partial thromboplastin time (aPTT)
- 3. Fibrinogen (Clauss method)
- 4. Coagulation factors II, V, VII, VIII, VWF, 1X, X, XI, XII
- 5. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
- 6. Plasminogen

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

Control Plasma N (modified) and Control Plasma P (modified) are substantially Oontrol Plasma N (modified) and Gontrol Plasma N (K023309) and Control Plasma P (K023312) currently marketed. The products differ from their predicate in that their value assignment process has changed for some of the reagents.

#### Device Performance Characteristics: 7.

Control Plasma N and Control Plasma P values are substantially equivalent to the current legally marketed devices, K023309 and K023312.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna Wolf Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

Re: k042209 Trade/Device Name: Control Plasma N and Control Plasma P Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: II Product Code: GGN, GIZ, GGC Dated: September 30, 2004 Received: October 8, 2004

OCT 2 1 2004

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 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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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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

K 043209

Control Plasma N Device Name:

## Indications for Use:

Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range:

- 1. Prothrombin time (PT)
- 2. Activated partial thromboplastin time (APTT)
- 3. Thrombin time (TT)
- 4. Batroxobin time
- 5. Fibrinogen
- 6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
- 7. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
- 8. Plasminogen
- 9. Lupus anticoagulants

> Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Souphine Bautista

Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k) K042209

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## Indications for Use Statement

510(k) Number (if known): K042209

Control Plasma P Device Name:

## Indications for Use:

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

- 1. Prothrombin time (PT)
- 2. Activated partial thromboplastin time (aPTT)
- 3. Fibrinogen (Clauss method)
- 4. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
- 5. Inhibitors: Antithrombin III, protein C, protein S, a2 --antiplasmin
- 6. Plasminogen

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device on and Sat

510(k) K042209