Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as a - antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.

Device Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and study particulars for the Coamatic® Plasmin Inhibitor device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The device's performance was compared to a predicate device, the Coatest® Antiplasmin, demonstrating substantial equivalence. The key performance metrics are correlation and precision.

Acceptance Criteria Category	Specific Metric	Predicate Device Performance / Target	Reported Device Performance (Coamatic® Plasmin Inhibitor)	Assessment
Method Comparison	Correlation (r)	Demonstrated substantial equivalence to Coatest® Antiplasmin		Met
	ACL 300 (n=61)	Not explicitly stated as a value, but implied to be high for equivalence	0.95	Met
	Cobas Mira (n=43)	Not explicitly stated as a value, but implied to be high for equivalence	0.97	Met
	MLA Electra (n=43)	Not explicitly stated as a value, but implied to be high for equivalence	0.97	Met
	Test Tube (n=32)	Not explicitly stated as a value, but implied to be high for equivalence	0.96	Met
	Microplate (n=54)	Not explicitly stated as a value, but implied to be high for equivalence	0.94	Met
Precision	Within-run CV	Not explicitly stated as a specific numerical target for CV	5.9% (at 44.8% plasmin inhibitor concentration)	Met
			2.7% (at 99.3% plasmin inhibitor concentration)	Met

2. Sample Sizes and Data Provenance for Test Set

For the method comparison studies, the sample sizes varied depending on the instrument/method used:

ACL 300: n=61
Cobas Mira: n=43
MLA Electra: n=43
Test Tube method: n=32
Microplate method: n=54

The text does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth. The study is a method comparison, where the predicate device's results serve as the reference, rather than establishing a de novo ground truth by experts.

4. Adjudication Method for Test Set

The document does not mention any adjudication method like 2+1 or 3+1. This is expected given it's a method comparison study between two in vitro diagnostic tests, where the "ground truth" is typically defined by the predicate device's results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically relevant for interpretative devices where human performance with and without AI assistance is being evaluated (e.g., radiology AI). The Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for quantitative determination, not an interpretative device requiring human readers in the loop.

6. Standalone (Algorithm Only) Performance

Yes. The reported performance is inherently standalone, as it describes the device's accuracy and precision in isolating and quantifying plasmin inhibitor activity. There is no human interpretation component described for the device's output itself. The comparison is between two analytical methods.

7. Type of Ground Truth Used

The "ground truth" for this study was the results obtained from the legally marketed predicate device, Coatest® Antiplasmin. The study aimed to demonstrate substantial equivalence by comparing the new device's measurements to those of the established predicate.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is typical for an IVD device submission that focuses on validation against a predicate rather than a machine learning model that requires a distinct training phase.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned (as this is not a machine learning-based device), this information is not applicable and not provided in the document.

Summary

{0}------------------------------------------------

SEP 28 1998

ﻬﺎ ﻓﻬ

Section 3 Coamatic® Plasmin Inhibitor - 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 Fax: (781) 861-4464

Contact Persons:

Carol Marble Phone: (781) 861-4467

Summary Prepared:

May 21, 1998

Name of the device:

Coamatic® Plasmin Inhibitor

Classification name(s):

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

Identification of predicate device(s):

K833890 Coatest® Antiplasmin

Description of the device/intended use(s):

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

Coamatic® Plasmin Inhibitor uses the same test principle as the predicate Coatest® Antiplasmin and is substantially equivalent in performance, intended use, and safety and effectiveness.

Summary of Performance Data:

In method comparison studies comparing the new Coamatic® Plasmin Inhibitor to the predicate Coatest® Antiplasmin, the correlation (r) on an ACL 300 (n=61) was 0.95, on a Cobas Mira (n=43) was 0.97, on an MLA Electra (n=43) was 0.97, and using the test tube (n=32) and microplate (n=54) methods was 0.96 and 0.94, respectively.

Within run precision assessed over multiple runs gave a CV of 5.9% (at a mean plasmin inhibitor concentration of 44.8%) and 2.7% (at a mean plasmin inhibitor concentration of 99.3%).

Section 3

Coamatic® Plasmin Inhibitor 510(k)

Page 1 of 1

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right.

SEP 28 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Requlatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173

Re : K981817/S1 Trade Name: Coamatic® Plasmin Inhibitor Regulatory Class: II Product Code: GGP Dated: September 8, 1998 Received: September 9, 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 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 (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

{2}------------------------------------------------

Page 2

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 diaqnostic 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 requiation 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

{3}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coamatic® Plasmin Inhibitor

Indications for Use:

Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as ca-antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.

(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	K981817

Prescription Use (Per 21 CFR 801.019)	✓	OR	Over-The-Counter Use
---------------------------------------	--------------	----	----------------------

Section 2 Coamatic® Plasmin Inhibitor 510(k) Page 1 of 1

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).