Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.

AI/ML Overview

Here's an analysis of the Coamatic® AT-400 device's acceptance criteria and the supporting study, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Predicate Device Performance / Target	Coamatic® AT-400 Performance
Method Comparison	Slope	Not explicitly stated as a target, but predicate device served as comparison.	0.9810
	Intercept	Not explicitly stated as a target, but predicate device served as comparison.	4.9773
	Correlation (r)	A high correlation (close to 1) indicates substantial equivalence.	0.995
Precision	CV% (Within run)	No explicit target stated.	1.80% (113% AT)
			2.64% (59% AT)
			4.52% (31% AT)
	CV% (Total)	No explicit target stated.	2.81% (113% AT)
			3.23% (59% AT)
			4.76% (31% AT)

Note: The document states that "Coamatic® AT-400 is substantially equivalent in performance to the predicate device: IL Test™ Antithrombin." While specific numerical acceptance targets are not explicitly listed for each metric, the reported performance (high correlation, low CV%) demonstrates this substantial equivalence.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 61 citrated plasma samples.
- Data Provenance: Not specified (e.g., country of origin). The study involved "citrated plasma samples," which are human biological specimens. There is no indication of whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study involves a quantitative laboratory assay comparison, not an interpretative task requiring human expert adjudication for ground truth. The "ground truth" for the method comparison was established by the predicate device's measurement.
Adjudication method for the test set:
- Not applicable for this type of quantitative assay comparison. The comparison was based on direct numerical results from two different devices/methods.
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:
- No, an MRMC comparative effectiveness study was not conducted. This device is a quantitative in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging or interpretative tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Coamatic® AT-400 device (an automated in vitro diagnostic assay). Its performance was compared directly against a predicate device without human interpretation or intervention in the measurement process beyond standard laboratory operating procedures.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the method comparison study was established by the results from the predicate device, IL Test™ Antithrombin on ACL 9000. For precision, the control plasma levels served as references.
The sample size for the training set:
- Not applicable. This is a 510(k) summary for a traditional in vitro diagnostic device, not a machine learning or AI-driven algorithm. There is no concept of a "training set" in the context of this device's development as described.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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

K022195

AUG 0 7 2002

Section 3 Coamatic® AT-400 - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:

Contact Person:

Carol Marble. Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

July 3, 2002

Name of the Device:

Coamatic® AT-400

Classification Name(s):

864.7060	Antithrombin III Assay	Class II
81JBQ	Antithrombin III Quantitation

Identification of Predicate Device(s):

K980499 IL Test™ Antithrombin

Description of the Device/Intended use(s):

Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

Coamatic® AT-400 is substantially equivalent in performance to the predicate device: IL Test™ Antithrombin

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

Section 3 Coamatic® AT-400 - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In a method comparison study evaluating 61 citrated plasma samples with Antithrombin levels ranging in value from 10.4 to 125% AT activity, the correlation statistics for Coamatic® AT-400 on an ACL Futura versus the predicate device on an ACL 9000 are shown below:

System	Slope	Intercept	r	Reference Method
ACL Futura	0.9810	4.9773	0.995	IL Test TM Antithrombin on ACL 9000

Precision

Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results:

ACL Futura
Mean (% AT)	CV% (Within run)	n	CV% (Total)	n
113	1.80	6	2.81	60
59	2.64	6	3.23	60
31	4.52	6	4.76	60

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 0 7 2002

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: K022195

Trade/Device Name: Coamatic® AT-400 Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBQ Dated: July 3, 2002 Received: July 5, 2002

Dear Ms. Marble:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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 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 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,

Steven Butman

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

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coamatic® AT-400

Indications for Use:

Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.

Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.

(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	K022195
---------------	---------

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

Section 2	Coamatic® AT-400 510(k)	Page 1 of 1
-----------	-------------------------	-------------

Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).