CONTROL PLASMA N, PROC CONTROL PLASMA

K042333 · Dade Behring, Inc. · GGN · Dec 1, 2004 · Hematology

Device Facts

• Record ID: K042333
• Device Name: CONTROL PLASMA N, PROC CONTROL PLASMA
• Applicant: Dade Behring, Inc.
• Product Code: GGN · Hematology
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Control Plasma N is an assayed control used to monitor the performance of the following parameters in the normal range: Prothrombin time (PT), Activated partial thromboplastin time (APTT), Thrombin Time (TT), Bastroxobin time, Fibrinogen, Coagulation Factors II, V, VII, VIII, vWF, IX, X, XI, XII, inhibitors: Antithrombin III, protein C, protein S, α2-antiplasin, Plasminogen, Lupus anticoagulants and Factor V Leiden. The ProC® Control Plasma is an assayed control intended to monitor the performance of Factor V Leiden assay in the pathological range.

Device Story

Lyophilized plasma controls; Control Plasma N (pooled human plasma, HEPES buffer); ProC® Control Plasma (pooled human and rabbit plasma, HEPES buffer). Used in clinical laboratories to monitor coagulation assay performance; ensures accuracy of test results for PT, APTT, and various coagulation factors. Reconstituted by laboratory personnel; stability validated for 4 hours at 15-25°C or 4 weeks at -20°C. Provides quality control metrics for healthcare providers to verify instrument/reagent system performance; supports clinical decision-making by ensuring reliable diagnostic data for coagulation disorders.

Clinical Evidence

No clinical studies performed. Analytical performance verified via real-time stability studies (4 hours at 15-25°C, 8 hours at 2-8°C, 4 weeks at -20°C). Factor V Leiden sensitivity for ProC® Control Plasma verified using 42 specimens from previously diagnosed Factor V Leiden deficient individuals; control material recovered within expected ranges.

Technological Characteristics

Lyophilized, stabilized pooled human plasma. ProC® Control Plasma includes rabbit plasma to adjust sensitivity for Factor V Leiden. Stabilized with HEPES buffer. Compatible with mechanical and photo-optical coagulation analyzers. No specific ASTM standards cited.

Indications for Use

Indicated for use as quality control material for coagulation assays in clinical laboratory settings. Control Plasma N monitors normal range performance for PT, APTT, TT, Bastroxobin time, Fibrinogen, coagulation factors, and inhibitors. ProC® Control Plasma monitors Factor V Leiden assay performance in the pathological range.

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 N (K023309)
• Chromogenix Control Plasma Level 2 (K963111)

Submission Summary (Full Text)

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DEC - 1 2004

K042333

### 510(k) Summary Control Plasma N and ProC® Control Plasma Manufacturer's Name, Address, Telephone, and Contact Person, Date of

- Preparation:
1.

| Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>Marburg/Germany |
|----------------------|--------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc |

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101

Newark, Delaware 19714 Attn: Radames Riesgo Tel: [phone]

August 27, 2004 Preparation date:

#### Device Name/ Classification: 2.

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

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

Control Plasma N (K023309) and Chromogenix Control Plasma Level 2 (K963111)

#### 4. Device Description:

Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. ProC® Control Plasma is a lyophilized control prepared from pooled human plasma and rabbit plasma, and 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 anticoagulants
- 10. Factor V Leiden

ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.

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

Control Plasma N (modified) is substantially equivalent in intended use to Control Plasma N (K023309) and ProC® Control Plasma is substantially equivalent in intended use to Chromogenix Control Plasma Level 2 (K963111).

#### Device Performance Characteristics: 7.

Reconstituted stability data of Control Plasma N and ProC® Control Plasma met the acceptance criteria of recovering within the assigned values for the following claims: 4 hours at 15 to 25°; 4 weeks at -20°C or below.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

DEC - 1 2004

Re: k042333

Trade/Device Name: Control Plasma N and ProC® Control Plasma Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: November 3, 2004 Received: November 4, 2004

Dear Mr. Riesgo:

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):

K042333

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, α2 –antiplasmin
- 8. Plasminogen
- 9. Lupus anticoagulants
- 10. Factor V Leiden

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div> <span>✓</span> </div> | AND/OR | Over-The-Counter Use<br>(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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K042333 |
|--------|---------|
|--------|---------|

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# Indications for Use Statement

510(k) Number (if known): K042333

ProC® Control Plasma Device Name:

### Indications for Use:

ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.

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 Evaluation and Safety

510(k) K042333