Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in the indentification of factor VIII deficiency or to monitor patients on replacement therapy as well as for potency estimation of FVIII concentrates.

Device Description

Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods.

AI/ML Overview

The provided text describes the Coamatic® Factor VIII device, its intended use, and a summary of performance data comparing it to a predicate device, Coatest® Factor VIII. It also includes the FDA's 510(k) clearance letter.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Correlation with Predicate Device (r)	High correlation (close to 1.0)	0.99 (compared to Coatest® Factor VIII)
Within-run Precision (CV)	Low CV, indicating good reproducibility	1.87% (at 1.0 IU/mL FVIII) 2.57% (at 0.21 IU/mL FVIII) 2.76% (at 0.025 IU/mL FVIII)

Note: The document implicitly suggests that substantial equivalence to the predicate device in performance is the acceptance criterion. The high correlation and low CV values demonstrate that the Coamatic® Factor VIII meets this implied criterion.

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

Sample Size for Test Set: 69 plasma samples for the method comparison study.
Data Provenance: Not explicitly stated, but the mention of "human citrated plasma" suggests human biological samples were used. The country of origin and whether the data was retrospective or prospective are not provided in the text.

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

This information is not provided in the document. The study described is a method comparison and precision study, not one that typically involves expert ground truth establishment in the traditional sense of diagnostic accuracy for subjective interpretation. The "ground truth" for the comparison is the measurement from the predicate device.

4. Adjudication Method for the Test Set

Not applicable/Not provided. The study involves quantitative measurements and comparison between devices, not subjective assessments requiring adjudication by multiple experts.

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

No. An MRMC study was not conducted. The study focused on device performance (correlation and precision) rather than the impact on human reader performance.

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

Yes, effectively. The performance data presented (correlation and precision) are for the device (Coamatic® Factor VIII) itself, measuring Factor VIII activity. This represents the standalone performance of the analytical method.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device (Coatest® Factor VIII) for the method comparison, and the known concentrations of Factor VIII in the samples for the precision study (as implied by "at a Factor VIII concentration of..."). It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is an in vitro diagnostic assay, not an AI/machine learning algorithm that typically requires a distinct training set. The "development" of such assays involves establishing reagents, reaction conditions, and calibration, rather than training on labeled data in the AI sense.

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

Not applicable/Not provided. As explained above, the concept of a "training set" and "ground truth for a training set" as used for AI algorithms does not directly apply to this type of in vitro diagnostic device. The development process would involve optimizing the assay's chemical and enzymatic reactions, reagent concentrations, and calibration curves.

Summary

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APR 1 6 1998

Section 3 Coamatic® Factor VIII - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:

Contact Persons:

Carol Marble Phone: (781) 861-4467

Summary Prepared:

March 18, 1998

Name of the device:

Coamatic® Factor VIII

Classification name(s):

864.7290 Factor Deficiency Test Class II Test, Qualitative and Quantitative Factor Deficiency 81GGP

Identification of predicate device(s):

Coatest® Factor VIII K833892

Description of the device/intended use(s):

Statement of How the Technological Characteristics of the Device Compare to the Predicate Device:

Coamatic® Factor VIII uses the same general test principle as the predicate Coatest® Factor VIII and is substantially equivalent in performance, intended use, and safety and effectiveness.

Summary of Performance Data:

In a method comparison study evaluating 69 plasma samples, the correlation (r) of the new Coamatic® Factor VIII on a Cobas Mira S as compared to the predicate Coatest® Factor VIII using a manual test tube method was 0.99.

Within run precision assessed over multiple runs gave a CV of 1.87% (at a Factor VIII concentration of 1.0 IU/mL), 2.57% (at a Factor VIII concentration of 0.21 IU/mL) and 2.76% (at a Factor VIII concentration of 0.025 IU/mL).

Coamatic® Factor VIII 510(k)

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Image /page/1/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 an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR | 6 1398

Carol Marble . Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

K981038 Re : Coamatic® Factor VIII Requlatory Class: II Product Code: GGP Dated: March 18, 1998 Received: March 19, 1998

Dear Ms. Marble:

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 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 qeneral 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 Requlations, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, -as setforth in the Quality System Regulation (QS) 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 requlatory In addition, FDA may publish further announcements action. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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™ (21 CFR 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/dsmamain.html".

Sincerely yours,
Steven Litman

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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Indications for Use Statement

510(k) Number (if known): __

Device Name: Coamatic® Factor VIII

Indications for Use:

Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in identifying factor VIII deficiency or monitoring patients on replacement therapy as well as for potency estimation of FVIII concentrates.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
981038

Prescription Use (Per 21 CFR 801.019) OR

Over-The-Counter Use _

Section 2

Coamatic® Factor VIII 510(k)

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).