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 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.

AI/ML Overview

The Dade Behring Inc. Control Plasma P is a lyophilized control prepared from pooled human plasma, intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological range.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Stability (Reconstituted)	Recovering within the assigned values for:	Met acceptance criteria (details below)
	- 4 hours at +15 to +25°C	Recovered within assigned values
	- 4 weeks at -20°C	Recovered within assigned values
	- 2 hours after thawing at +15 to +25°C (after 4 weeks storage at -20 to -30°C)	Recovered within assigned values

2. Sample size used for the test set and the data provenance:

Sample Size: The document states "In duplicate determinations," which indicates that the stability tests were performed at least twice for each condition. However, a specific numerical sample size (e.g., number of vials, number of lots) beyond "duplicate determinations" is not provided.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is a submission for a 510(k) modification, implying that the data was generated specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and study. The "ground truth" for a control plasma in this context refers to the assigned values or defined factor concentrations of the control and the expected performance within a specified range. These are established through manufacturing processes, analytical methods, and internal quality control, not by expert consensus readings of an outcome.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., imaging studies) where there might be disagreement in expert opinions. For a quantitative test like a control plasma, the determination of whether the device "recovers within the assigned values" is an objective, analytical measurement.

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 information is not applicable. The Control Plasma P is an in-vitro diagnostic (IVD) control material, not an AI-powered diagnostic tool, nor does it involve human readers in the context of interpretation. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

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

This question is not applicable for this device. The Control Plasma P is a reagent (control material), not an algorithm or an automated diagnostic system that performs a standalone analysis. Its "performance" is its stability and its ability to consistently yield specific assay values when tested on laboratory instruments.

7. The type of ground truth used:

The ground truth used for this device is based on assigned values/defined factor concentrations of the control plasma. The document states it is "adjusted to defined factor concentrations" and the performance criteria involve "recovering within the assigned values." This refers to the pre-established, analytically determined target values for the various coagulation and fibrinolysis parameters. These values are typically derived through extensive characterization during product development and manufacturing.

8. The sample size for the training set:

This information is not applicable as the Control Plasma P is not an AI/machine learning model that requires a training set. Its "development" involves chemical and biological formulation, stabilization, and analytical characterization rather than algorithmic training.

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

This information is not applicable for the same reasons as #8.

Summary

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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 GmbHEmil-von-Behring Str. 76Marburg/Germany
Contact Information:	Dade Behring Inc.Glasgow SiteP.O. Box 6101Newark, Delaware 19714Attn: Donna WolfTel: 302-631-0384
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:

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
1. 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)

Regulation Number and Section

§ 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.