For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.

Device Description

Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Dade® Thrombin Reagent, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for the Dade® Thrombin Reagent is demonstrated through a method comparison study against the legally marketed predicate device, the Dade® Fibrinogen Determination Reagents kit. The acceptance criteria are implicit in the "Correlation Coefficient" values, indicating a strong correlation between the new device and the predicate.

Acceptance Criteria (Stated/Inferred)	Reported Device Performance (Dade® Thrombin Reagent vs. Dade® Fibrinogen Determination Reagents)
High Correlation (e.g., >0.90) with Predicate Device	Slope: 1.03, Intercept: -0.063, Correlation Coefficient: 0.995 (for SHP Lot # 502587)
	Slope: 0.946, Intercept: -0.027, Correlation Coefficient: 0.993 (for SHP Lot # 502589)

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 80 samples were used for each of the two lots tested (SHP Lot # 502587 and SHP Lot # 502589), for a total of 160 samples in the method comparison study.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This is an in vitro diagnostic device for quantitative determination, not an imaging or qualitative diagnostic device requiring expert interpretation of results for ground truth establishment in the traditional sense. The "ground truth" for comparison is the performance of the legally marketed predicate device.
Adjudication Method for the Test Set:
- Not applicable, for the same reasons as point 2. The comparison is quantitative against a predicate device.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study was not done. MRMC studies are typically used for imaging devices or diagnostics that involve human interpretation, which is not the primary function of this in vitro diagnostic reagent.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Yes, in a sense. The performance presented is for the reagent itself, functioning on an instrument. There is no "human-in-the-loop" component in the direct measurement process of a fibrinogen level using a coagulation assay. The device determines the fibrinogen level directly.
The Type of Ground Truth Used:
- Comparative Ground Truth: The "ground truth" for this device's performance evaluation is established by comparison to a legally marketed predicate device. The predicate device itself (Dade® Fibrinogen Determination Reagents kit) serves as the reference standard. The study aims to show that the new device produces results that are highly correlated and comparable to the established method.
The Sample Size for the Training Set:
- The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. For a reagent test, development typically involves analytical validation and optimization rather than a separate training set for a "machine learning" algorithm.
How the Ground Truth for the Training Set was Established:
- Not applicable, as a discrete "training set" with established ground truth as understood in machine learning is not described or required for this type of in vitro diagnostic reagent. The development of such reagents generally relies on established chemical and biological principles, optimization through analytical testing, and ultimately validation against reference methods or clinical samples.

Summary

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510(k) Summary for Dade® Thrombin Reagent

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K050928

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

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date:

June 24, 2005

2.	Device Name	Dade® Thrombin Reagent and Dade® Owren's Veronal Buffer
	Classification:	Fibrinogen Determination System, Class II, 21 CFR 864.7340
	Panel:	Hematology
	Product Code:	KQJ

ldentification of the Legally Marketed Device: 3.

Dade® Fibrinogen Determination Reagents kit (Pre-1976) and Dade® Thrombin Reagent (BK860038)

Device Description: 4.

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5. Device Intended Use:

For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.

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

The modified Dade Thrombin Reagent is substantially equivalent to the currently marketed Dade® Fibrinogen Determination Reagents kit (Pre-1976) and Dade® Thrombin mancied Daoc The modified Dade Thrombin Reagent, like the current Dade Fibrinogen Determination Reagents kit is intended for use in the quantitative determination of fibrinogen in human plasma and to accelerate coagulation of anticoagulated samples for immunohematological studies.

Device Performance Characteristics: 7 .

Method Comparison Study Dade® Fibrinogen Determination Reagents vs. Dade® Thrombin Reagent

Dade® ThrombinReagent	(n=)	Slope	Intercept	CorrelationCoefficient
SHP Lot # 502587	80	1.03	-0.063	0.995
SHP Lot # 502589	80	0.946	-0.027	0.993

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JUN 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

K050928 Re:

Trade/Device Name: Dade® Thrombin Reagent Regulation Number: 21 CFR § 864.7340 Regulation Name: System, Fibrinogen Determination Regulatory Class: II Product Code: KQJ Dated: April 13, 2005 Received: April 14, 2005

Dear Ms. Dray-Lyons:

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 for are cased a a 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 or any I odeful 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 Of It Fart 6077, acceming (21 the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form arketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleate 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, If you destions on the promotion and advertising of your device, please contact the Office of In of quotions on the promise Evaluation and Safety at (240) 276-0484. Also, please note the v tro Diagnoution . "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may obtain of Scherar ne 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/industry/support/index.html

Sincerely yours,

Robert Beckerh

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

Enclosure

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Dade Behring Inc. Dade® Thrombin Reagent 510(k) Notification - Modification

Indications Statement

K050928

Device Name:

Dade® Thrombin Reagent

Indications for Use:

muleations for Goo.
For use in the quantitative determination of fibrinogen in plasma and to accelerate r or ass in the quantically ated samples for immunohematology studies.

Prescription Use
(Per 21 CFR 801 Subpart D)

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)

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Atuxhina Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) kasagar

000030

Regulation Number and Section

§ 864.7340 Fibrinogen determination system.

(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.