The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.

Device Description

Dade Behring Heparin Calibrator and Controls are lyophilized products prepared from citrated human plasma and contain unfractionated heparin from a porcine source. The kit consists of a calibrator and two levels of assayed controls intended to monitor the performance of Berichrom® Heparin reagent when testing for unfractionated heparin using coagulation analyzers.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Heparin Calibrator and Controls, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the performance characteristics demonstrating equivalence and doesn't explicitly list "acceptance criteria" in a typical table format for all parameters. However, it does describe the performance that met the criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Reconstituted Stability: Recovery within assigned values.	Recovered within the assigned values when stored for eight (8) hours at 2 to 8°C.
Method Comparison (Regression Analysis) - Dade Behring BCS® Analyzer: Strong correlation and agreement with USP Heparin Sodium Reference Standard.	Y = 1.07 X - 0.01, r = 0.9985 (Excellent correlation, close to ideal Y=X)
Method Comparison (Regression Analysis) - Sysmex® CA-1500 Analyzer: Strong correlation and agreement with USP Heparin Sodium Reference Standard.	Y = 0.97 X + 0.01, r = 0.9996 (Excellent correlation, close to ideal Y=X)

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

Sample Size: The document states that the stability data used "at least duplicate determinations." For the method comparison studies, it mentions "different dilutions of USP Heparin Sodium Reference Standard were spiked into citrated plasma samples." The exact number of samples or dilutions is not specified.
Data Provenance: The data appears to be from a prospective study conducted by the manufacturer, Dade Behring Inc. The country of origin of the data is not explicitly stated, but the manufacturer is based in Newark, Delaware, USA.

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

This device is a calibrator and control material for an in vitro diagnostic assay. The ground truth for this type of device is typically established through a reference standard rather than expert interpretation of images or clinical data.
The study used the USP Heparin Sodium Reference Standard to establish the true heparin concentrations. Therefore, there were no "experts" in the traditional sense required to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

Given that the ground truth was established by a reference standard, an adjudication method is not applicable in this context. The measurements were quantitative and compared against known values derived from the reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No. This is an in vitro diagnostic device (calibrator and control) and not an AI-powered diagnostic tool for image interpretation or similar tasks requiring human readers. Therefore, an MRMC study is not relevant aquí.

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

Yes, effectively. The performance evaluation described is for the device (calibrator and controls) used with coagulation analyzers (Dade Behring BCS® Analyzer and Sysmex® CA-1500 Analyzer). The "performance" of the calibrator and controls is assessed in their ability to correctly calibrate and monitor the assay. There isn't a human-in-the-loop scenario described; the evaluation is of the analytical performance of the products themselves in combination with the specified instrumentation.

7. The Type of Ground Truth Used

The ground truth used was reference standard data, specifically the USP Heparin Sodium Reference Standard. This standard was used to:
- Spike known concentrations of heparin into plasma samples.
- Establish the calibration curve against which the new calibrator's performance was evaluated.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the calibrator and controls. These are standardized materials, and their development typically involves extensive characterization and formulation work rather than machine learning training sets. The studies described are validation (test set) studies to demonstrate performance.

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

Not applicable, as a "training set" in the machine learning sense is not mentioned or implied for this type of in vitro diagnostic product. The fundamental "ground truth" for the calibrator's development would ultimately trace back to primary reference materials and methods for unfractionated heparin, though specifics are not detailed here.

Summary

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K04294/

DEC - 2 2004

510(k) Summary Heparin Calibrator and Controls Manufacturer's Name, Address, Telephone, and Contact Person,

Date of Preparation: Dade Behring Inc. Manufacturer: P.O. Box 6101

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714 Attn: Radames Riesgo Tel: 305.480.7558

October 22, 2004 Preparation date:

2. Device Name/ Classification:

Dade Behring Heparin Calibrator and Controls / Multipurpose system for in vitro coagulation studies, Class II (864.5425)

Newark, Delaware 19714

3. Identification of the Legally Marketed Device:

aca® Heparin Calibrator (K843202)

Ci-Trol® Heparin Controls, Low and High (K812424)

4. Device Description:

5. Device Intended Use:

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

The Heparin Calibrator is substantially equivalent in intended use to Dade Behring aca® Heparin Calibrator, Level 3 (K843202). The Controls are substantially equivalent to Dade Behring Ci-trol® Heparin Controls, Low and High (K812424).

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7. Device Performance Characteristics:

Using at least duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values when stored for eight (8) hours at 2 to 8°C.

Different dilutions of USP Heparin Sodium Reference Standard were spiked into citrated plasma samples and the heparin recovery evaluated using a calibration curve established using the USP Heparin Sodium Reference Standard. The same samples were then measured using a calibration curve established with the new Heparin calibrator. Results were compared using regression analysis and the following statistics were obtained:

Dade Behring BCS® Analyzer:	$Y = 1.07 X - 0.01, r = 0.9985$
Sysmex® CA-1500 Analyzer:	$Y = 0.97 X + 0.01, r = 0.9996$

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

DEC - 2 2004

K042941 Re:

Trade/Device Name: Dade Behring Heparin Calibrator and Controls Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GIZ Dated: October 22, 2004 Received: October 25, 2004

Dear Mr. Riesgo:

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,

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):

Dade Behring Heparin Calibrator and Controls Device Name:

Indications for Use:

Prescription Use

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device
Evaluation and Safety

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801)

510(k) K042941

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.