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K Number
K042209
Device Name
CONTROL PLASMA N AND CONTROL PLASMA P
Manufacturer
DADE BEHRING, INC.
Date Cleared
2004-10-21

(66 days)

Product Code
GGN,GGC,GIZ
Regulation Number
864.5425
Type
Traditional
Panel
Hematology
Reference & Predicate Devices
K023309,K023312
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

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.

AI/ML Overview

This 510(k) summary (K042209) is for Control Plasma N and Control Plasma P, which are assayed controls for monitoring in vitro coagulation studies. It does not describe an AI medical device, but rather a laboratory control product. Therefore, many of the requested details, such as those related to AI performance, human reader studies, and training/test set specifics, are not applicable to this document.

Here's an analysis based on the provided text, focusing on the concepts that are relevant to this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table as one would for an AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for these control plasmas is substantial equivalence to their legally marketed predicate devices.

Acceptance Criteria (Implicit)Reported Device Performance
Substantial Equivalence to Predicate Devices (K023309 and K023312)"Control Plasma N and Control Plasma P values are substantially equivalent to the current legally marketed devices, K023309 and K023312."
Functionality as an assayed control for specified coagulation parameters in normal (Control Plasma N) or pathological (Control Plasma P) ranges.Intended Use statements explicitly list the coagulation parameters for each control, indicating they function as designed for monitoring these.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a medical device like a control plasma, the "test set" would typically refer to the samples used during the internal validation studies to demonstrate its performance and equivalence. The summary only states that the "value assignment process has changed for some of the reagents," implying internal testing was conducted to re-establish values and demonstrate equivalence, but no details on sample size or provenance are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in the context of this device. "Ground truth" for an in vitro diagnostic control like this is established through analytical methods and calibration processes against reference materials, not typically by expert review in the way it would be for an image-based AI diagnostic. The "values" for the control plasmas are determined through laboratory procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for this type of device. Adjudication methods are used to establish ground truth in complex, subjective diagnostic tasks, often in image interpretation or clinical diagnosis. For a coagulation control, the "truth" (i.e., the assigned values) is determined through analytical testing and statistical methods, not by expert consensus or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used to evaluate diagnostic imaging devices with human readers, often involving AI assistance. This document describes a quality control plasma, which does not involve "human readers" interpreting an output in the same way.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a consumable, assayed control plasma, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" (the assigned values for the various coagulation parameters in the control plasmas) is established through analytical testing and calibration against reference methods/materials. The summary indicates a "value assignment process has changed for some of the reagents," suggesting a laboratory-based method for determining these values. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. As it's not an AI/machine learning device, there is no training set or ground truth in that context.

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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: 302-631-0384

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)
    1. Activated partial thromboplastin time (APTT)
    1. Thrombin time (TT)
    1. Batroxobin time
    1. Fibrinogen
    1. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
    1. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
    1. Plasminogen
    1. 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)
    1. Activated partial thromboplastin time (aPTT)
    1. Fibrinogen (Clauss method)
    1. Coagulation factors II, V, VII, VIII, VWF, 1X, X, XI, XII
    1. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
    1. 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)
    1. Activated partial thromboplastin time (APTT)
    1. Thrombin time (TT)
    1. Batroxobin time
    1. Fibrinogen
    1. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
    1. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
    1. Plasminogen
    1. 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)
    1. Activated partial thromboplastin time (aPTT)
    1. Fibrinogen (Clauss method)
    1. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
    1. Inhibitors: Antithrombin III, protein C, protein S, a2 --antiplasmin
    1. 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

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.