For the calibration of the following tests: Prothrombin time (PT), Fibrinogen, Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII and XIII*, Inhibitors: Antithrombin III, Protein C, Protein S, α2-antiplasmin, C1-inhibitor*, Total complement activity*, Plasminogen. (* Not available in the U.S.)

Device Description

Standard Human Plasma is a lyophilized calibrator prepared from pooled citrated human plasma, stabilized with buffer solution and then lyophilized. It is assayed for the calibration of various coagulation and fibrinolysis tests

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "Standard Human Plasma." This device is a calibrator for in vitro coagulation and fibrinolysis studies.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Reconstituted stability within assigned values:	Met acceptance criteria (recovered within assigned values) for:
- 4 hours at +15 to +25°C	Detected: 4 hours at +15 to +25°C
- 4 weeks at -20 to -30°C	Detected: 4 weeks at -20 to -30°C (2 hours after thawing at +15 to +25°C)

2. Sample Size Used for the Test Set and Data Provenance:

The document states "In duplicate determinations," which indicates that stability testing was performed with at least two samples for each condition. However, the exact sample size beyond "duplicate" is not provided. The provenance of the data is not mentioned (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The "ground truth" for a calibrator like Standard Human Plasma would typically be established by comparing its performance against established reference materials or methods. The document only states that the device "recovered within the assigned values," implying a comparison to these established values, but it does not detail the process or experts involved in establishing those "assigned values."

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of data (e.g., image analysis, clinical diagnoses) where multiple experts assess the same cases and a consensus or tie-breaking mechanism is needed. For a calibrator's stability testing, the outcome is quantitative (recovery within assigned values), thus not requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study investigates how human readers' performance is affected by AI assistance, which is relevant for diagnostic AI tools. Standard Human Plasma is a calibrator, not a diagnostic AI tool, so an MRMC study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence, standalone performance was assessed. The device itself (a lyophilized calibrator) performs its function independently of a human operator making interpretive decisions about the calibration itself. The stability testing described is a standalone performance evaluation of the calibrator's ability to maintain its assigned values over time. However, it's not an "algorithm-only" performance study in the context of AI, but rather a performance study of a physical product.

7. The Type of Ground Truth Used:

The ground truth used for the stability testing was referred to as "assigned values." These assigned values would typically be established through expert consensus or by comparison to reference methods/materials that are themselves considered the gold standard for coagulation and fibrinolysis measurements. The document does not explicitly state the specific method used to establish these assigned values, but it implies a pre-defined set of expected values for the calibrator.

8. The Sample Size for the Training Set:

This information is not applicable and not provided because this device is not an AI/machine learning algorithm that requires a training set. It is a physical calibrator.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided for the same reason as above (not an AI/ML algorithm).

Summary

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K023141

JAN 1 6 2003

510(k) Summary Standard Human Plasma

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 September 19, 2002

Preparation date:

2. Device Name/ Classification:

Standard Human Plasma / Multipurpose system for in vitro coagulation studies (864.5425)

3. Identification of the Legally Marketed Device:

Standard Human Plasma (K924393)

4. Device Description:

5. Device Intended Use:

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

Standard Human Plasma (modified) is substantially equivalent in intended use to the Standard Human Plasma (K924393) currently marketed. Standard Human Plasma (modified), like the current Standard Human Plasma is intended for the calibration of coagulation and fibrinolysis tests 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 to -30°C (2 hours after thawing at +15 to +25°C, stored for 4 weeks at -20 to -30°C.)

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna Wolf Senior Regulatory Affairs Specialist Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

JAN 1 6 2003

Re: K023141

Trade/Device Name: Standard Human Plasma Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: December 17, 2002 Received: December 18, 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 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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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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. Standard Human Plasma 510(k) Modification

Indications for Use Statement

Device Name: Standard Human Plasma

Indications for Use:

For the calibration of the following tests:

1. Prothrombin time (PT)
1. Fibrinogen
1. Coagulation factors II, V, VII, VIII, WWf, IX, X, XI, XII and XIII*
1. Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C1-inhibitor*
1. Total complement activity*
1. Plasminogen

Not available in the U.S.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

Auriphene Bautista

(Division Sign-Off) Division of Clinical Laborator 510(k) Number

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.