Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.

Device Description

The Fibrinogen Calibrators are lyophilized calibrators prepared from pooled human plasma from selected, healthy donors, diluted with buffered solution or supplemented with purified fibrinogen and stabilized.

AI/ML Overview

The provided text describes a 510(k) notification for the Dade Behring Inc. Fibrinogen Calibrator Kit. This document focuses on the intended use and substantial equivalence of the device to a legally marketed predicate device (Dade Behring Fibrinogen Standards K925988), rather than a study proving performance against specific acceptance criteria for a new clinical diagnostic or imaging device.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable to the information provided in this 510(k) summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not Applicable/Not Provided: The submission is for a calibrator kit, not a diagnostic device with specific performance metrics like sensitivity, specificity, or AUC against a ground truth. The acceptance criteria for a calibrator kit typically relate to its ability to establish a stable and accurate reference curve for a known assay, ensuring that the assay measurements are reliable. While the device is "substantially equivalent" to a predicate, specific quantitative performance data for the calibrator itself against predefined acceptance criteria (e.g., precision, stability, lot-to-lot consistency) are not detailed in this summary.

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

Not Applicable/Not Provided: This information is not part of the 510(k) summary provided. The nature of a calibrator kit means that "sample size" in the context of diagnostic performance studies is not relevant. The human plasma used to prepare the calibrators is stated to be from "selected, healthy donors," but no further details on sample size or provenance for testing the calibrator's performance 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)

Not Applicable/Not Provided: Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for a calibrator would be its own assigned fibrinogen concentration, which is established through a different validation process (e.g., using reference methods and materials), not by expert consensus on patient cases.

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

Not Applicable/Not Provided: Adjudication methods are used in studies involving subjective interpretation of diagnostic results (e.g., imaging). This is not relevant for a calibrator kit.

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

Not Applicable/Not Provided: This is a calibrator kit for an in vitro diagnostic assay, not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement are not relevant.

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

Not Applicable/Not Provided: This device is not an algorithm.

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

Not Applicable/Not Provided: As mentioned above, ground truth in the context of patient diagnosis is not relevant for a calibrator kit. The "truth" for the calibrator itself would be its characterized concentration values, established through metrological traceability.

8. The sample size for the training set

Not Applicable/Not Provided: This is not an AI/machine learning device that requires a training set.

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

Not Applicable/Not Provided: This is not an AI/machine learning device.

Summary

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Dade Behring Inc. Fibrinogen Calibrator Kit 510(k) Notification

K994341.

MAR - 3 2000

510(k) Summary for Fibrinogen Calibrator Kit

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

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 76Marburg/Germany
Contact Information:	Dade Behring Inc.Glasgow SiteP.O. Box 6101Newark, Delaware 19714Attn: Rebecca S. AyashTel: 302-631-6276
Preparation date:	December 22, 1999
Device Name Classifications

2. Device Name/ Classification:

Fibrinogen Calibrator Kit: Fibrinogen Calibrators

Class II (864.7340) Classification Number:

Identification of the Legally Marketed Device: 3.

Dade Behring Fibrinogen Standards (K925988)

4. Device Description:

ર. Device Intended Use:

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.

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

There are a number of in vitro diagnostic products in commercial distribution, which are used for the establishment of reference curves. One such product is the Dade Behring Fibrinogen Standards (K925988). The Fibrinogen Calibrator Kit is substantially equivalent in intended use to the Fibrinogen Standards. The Fibrinogen Calibrator Kit, like the Fibrinogen Standards is intended to be used for the calibration of a fibrinogen assay

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

MAR - 3 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring Glasgow Site P.O. Box 6101 Newark, Delaware 19714

Re: K994341 Trade Name: Fibrinogen Calibrator Kit Regulatory Class: II Product Code: GFX Dated: February 18, 2000 Received: February 24, 2000

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 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 Putman

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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Dade Behring Inc. Fibrinogen Calibrator Kit 510(k) Notification

K994341

Indications for Use Statement

Fibrinogen Calibrator Kit Device Name:

Indications for Use:

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.

ion Sign-Off Division of Clinical Laboratory Devi 510(k) Number

(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)

000017

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.