ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

Device Description

ChromoCheck™ Antithrombin is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer

AI/ML Overview

ChromoCheck™ Antithrombin Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the ChromoCheck™ Antithrombin device. Instead, it demonstrates substantial equivalence to a predicate device (Coamatic Antithrombin) through a correlation study. The performance of ChromoCheck™ Antithrombin is assessed by its correlation with this predicate device.

Parameter	Acceptance Criteria	Reported Device Performance (ChromoCheck™ Antithrombin)
Correlation	(Inferred: Strong correlation with predicate device, typically R² > 0.95 and slope close to 1)	Lot 1: Y-intercept = 1.389, Slope = 0.988, R² = 0.992
		Lot 2: Y-intercept = -2.095, Slope = 1.036, R² = 0.989

Conclusion: The reported R² values of 0.992 and 0.989, and slopes close to 1 (0.988 and 1.036) indicate a very strong linear correlation with the predicate device, suggesting the device meets an implicit acceptance criterion of high concordance with an established method.

2. Sample Size and Data Provenance for Test Set

Sample Size: 50 normal and pathological patient samples.
Data Provenance: Not explicitly stated, but given the submitter's location (Dartmouth, Nova Scotia, Canada), it is likely to be from Canada or a mix of sources. The study is retrospective as it compares with an existing predicate.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The ground truth for this study is the measurement obtained from the predicate device, Coamatic Antithrombin, not expert consensus.

4. Adjudication Method for Test Set

Not applicable. The study involves direct comparison of quantitative measurements from two devices, not expert adjudication of subjective assessments.

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

Not applicable. This is not an AI/human-in-the-loop study. It is a comparison of two quantitative in-vitro diagnostic assays.

6. Standalone Performance Study

Yes, a standalone performance study was done for the ChromoCheck™ Antithrombin in the sense that its measurements were recorded independently. However, its effectiveness was determined by comparison to a predicate, rather than against an 'absolute' ground truth. The study demonstrates the device's ability to produce quantitative antithrombin activity results.

7. Type of Ground Truth Used

The "ground truth" for this study was the quantitative antithrombin activity results obtained from the predicate device, Coamatic® Antithrombin.

8. Sample Size for Training Set

Not applicable. This device is an in vitro diagnostic assay, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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510(K) Summary ChromoCheck™ Antithrombin

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 1402399 |

Submitters Name &Address:	Precision BioLogic Incorporated900 Windmill Road, Suite 100Dartmouth, Nova Scotia B3B 1P7Canada
Contact Name:	Stephen L. Duff - Director of New BusinessDevelopmentPhone: 902-468-6422 ext. 224Fax: 902-468-6421Email: sduff@precisionbiologic.com
Preparation Date:	November 29, 2002
Device Name &Classification:	ChromoCheck™ AntithrombinCommon Name: Antithrombin chromogenic assayClassification Name: Antithrombin quantitationRegulatory Class II, 81 JBQ
Predicate Device:	Chromogenix AB/ Instrumentation LaboratoryTaljegardsgatan 3S-431 53 MolndalSweden, SW
Device Description:	ChromoCheck™ Antithrombin is a chromogenicassay consisting of a synthetic substrate, Factor Xa,and a Tris Heparin Buffer
Device Intended Use:	ChromoCheck™ Antithrombin is intended for use asa chromogenic assay for the quantitativedetermination of antithrombin activity in citratedhuman plasma.

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Parameter	ChromoCheckTM Antithrombin	Coamatic Antithrombin
Intended Use	Antithrombin quantitation	Antithrombin quantitation
Analytes	Antithrombin	Antithrombin
ComponentReagentMatrices	Reagent 1: Chromogenic substrate in adistilled water matrixReagent 2: Factor Xa - Bovine FactorXa in a Tris Heparin Buffer matrixReagent 3: Tris Heparin Buffer	Reagent 1: Chromogenic substrate in adistilled water matrixReagent 2: Factor Xa - Bovine FactorXa in a Tris Heparin Buffer matrixReagent 3: Tris Heparin Buffer
Format	Lyophilized	Lyophilized
Packaging	4 x Substrate (3.75 mg)4 x Factor Xa (5 µg)4 x 5 mL Tris Heparin Buffer(Reconstituted volume - 2.5 mL)4 x Substrate (3.75 mg)4 x Factor Xa (5 µg)4 x 10 mL Tris Heparin Buffer(Reconstituted volume - 5.0 mL)	2 x Substrate S-2772 (26 mg)6 x Factor Xa (90 nkat)6 x Buffer with heparin (25 mL)

Comparison to Predicate Device:

Comments on Substantial Equivalence:

It is the opinion of Precision BioLogic Inc. that ChromoCheck™ Antithrombin is substantially equivalent to Coamatic Antithrombin (K022195), manufactured by Chromogenix AB (originally Kabi Pharmacia, Inc.), and currently marketed in the United States by Instrumentation Laboratory. This opinion is based on the following:

both devices are based on synthetic chromogenic substrates ■
both devices contain Factor Xa from a bovine source I
. Both devices contain lyophilized reagents
Both devices consist of a substrate, which is reconstituted with distilled water, Factor Xa, I which is reconstituted with Tris Heparin Buffer, and Tris Heparin Buffer
u Both devices are intended for use in the quantitative determination of antithrombin activity in citrated human plasma
피 Both devices present results as a % activity of antithrombin

Correlation:

Two lot numbers of ChromoCheck™ Antithrombin were compared to Coamatic® Antithrombin in a correlation study using a mix of 50 normal and pathological patient samples. The following correlation was achieved:

Correlationparameter	ChromoCheckAntithrombin Lot 1	ChromoCheckAntithrombin Lot 2
Y-intercept	1.389	-2.095
Slope	0.988	1.036
R2	0.992	0.989

Conclusion: ChromoCheck™ Antithrombin is substantially equivalent to Coamatic® Antithrombin.

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Public Health Service

APR 2 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen L. Duff Director of New Business Development Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth, Nova Scotia Canada B3B 1P7

Re: K023991

Trade/Device Name: ChromoCheck 114 Antithrombin Regulation Number: 21 CFR 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: Class II Product Code: JBQ Dated: March 26, 2003 Received: March 28, 2003

Dear Mr. Duff:

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).

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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.

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). 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director 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:

ChromoCheck™ Antithrombin Device Name:

Koasgel

Indications for Use:

ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

Josephine Bautista

(Division Sign-Of Division of Clinical Laboratory Devices 510(k) Number

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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).