K Number
K022195
Device Name
COAMATIC AT-400
Date Cleared
2002-08-07

(33 days)

Product Code
Regulation Number
864.7060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
Device Description
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. 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.
More Information

Not Found

No
The description details a quantitative biochemical assay based on enzymatic reactions and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, or performance studies.

No.
The device is for the quantitative determination of antithrombin activity in plasma, which is a diagnostic function, not a therapeutic one.

Yes

Explanation: The device is intended for the "quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma." This measurement provides information about a patient's physiological state (antithrombin levels) and can be used to assess the risk of uncontrolled coagulation or thrombosis, which are diagnostic purposes.

No

The description details a method for determining antithrombin levels using chemical reactions and measuring absorbance at a specific wavelength (405 nm). This implies the use of reagents, a spectrophotometer, and likely an automated analyzer (like the ACL Futura mentioned in the performance studies), which are hardware components, not just software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states "quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma." This indicates the device is used to analyze a human biological sample (plasma) to obtain diagnostic information (antithrombin levels).
  • Device Description: The description further elaborates on how the device works by analyzing the activity of antithrombin in plasma using chemical reactions and measuring the result at a specific wavelength. This is characteristic of an in vitro diagnostic test.
  • Performance Studies: The inclusion of method comparison and precision studies, comparing the device to a predicate device and evaluating its performance with control plasma, are standard for IVD submissions.
  • Predicate Device: The mention of a predicate device (K980499 IL Test™ Antithrombin) which is also an IVD, strongly suggests that this device falls under the same category.

All these factors align with the definition and characteristics of an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JBQ

Device Description

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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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: ACL Futura, Slope: 0.9810, Intercept: 4.9773, r: 0.995, Reference Method: IL Test™ 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): 113, CV% (Within run): 1.80, n: 6, CV% (Total): 2.81, n: 60
Mean (% AT): 59, CV% (Within run): 2.64, n: 6, CV% (Total): 3.23, n: 60
Mean (% AT): 31, CV% (Within run): 4.52, n: 6, CV% (Total): 4.76, n: 60

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K980499

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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):

864.7060Antithrombin III AssayClass II
81JBQAntithrombin 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.

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.

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:

SystemSlopeInterceptrReference Method
ACL Futura0.98104.97730.995IL 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)nCV% (Total)n
1131.8062.8160
592.6463.2360
314.5264.7660

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) NumberK022195
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| Prescription Use

(Per 21 CFR 801.019)OROver-The-Counter Use
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