(146 days)
Not Found
No
The summary describes a chromogenic assay for quantitative determination of antithrombin activity, which is a chemical-based test, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic assay for quantitative determination of antithrombin activity, which is used for diagnosis, not treatment.
Yes
The device is described as an "in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma," which directly indicates its use in diagnosing or monitoring health conditions by measuring specific biomarkers in a sample.
No
The device description explicitly states it is a "chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma. This clearly indicates that the device is used to test samples taken from the human body outside of the body.
- Device Description: The description of the device as a "chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer" further supports its use in a laboratory setting for analyzing biological samples.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissues, to detect diseases, conditions, or infections. The information provided for ChromoCheck™ Antithrombin aligns perfectly with this definition.
N/A
Intended Use / Indications for Use
ChromoCheck™ Antithrombin is intended for use as a chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
Product codes
JBQ
Device Description
ChromoCheck™ Antithrombin is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer
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
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.
Key Metrics
Y-intercept: ChromoCheck Antithrombin Lot 1: 1.389, ChromoCheck Antithrombin Lot 2: -2.095
Slope: ChromoCheck Antithrombin Lot 1: 0.988, ChromoCheck Antithrombin Lot 2: 1.036
R2: ChromoCheck Antithrombin Lot 1: 0.992, ChromoCheck Antithrombin Lot 2: 0.989
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Incorporated
900 Windmill Road, Suite 100
Dartmouth, Nova Scotia B3B 1P7
Canada |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Stephen L. Duff - Director of New Business
Development
Phone: 902-468-6422 ext. 224
Fax: 902-468-6421
Email: sduff@precisionbiologic.com |
| Preparation Date: | November 29, 2002 |
| Device Name &
Classification: | ChromoCheck™ Antithrombin
Common Name: Antithrombin chromogenic assay
Classification Name: Antithrombin quantitation
Regulatory Class II, 81 JBQ |
| Predicate Device: | Chromogenix AB/ Instrumentation Laboratory
Taljegardsgatan 3
S-431 53 Molndal
Sweden, SW |
| Device Description: | ChromoCheck™ Antithrombin is a chromogenic
assay consisting of a synthetic substrate, Factor Xa,
and a Tris Heparin Buffer |
| Device Intended Use: | ChromoCheck™ Antithrombin is intended for use as
a chromogenic assay for the quantitative
determination of antithrombin activity in citrated
human plasma. |
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| Parameter | ChromoCheckTM Antithrombin | Coamatic Antithrombin |
|---|---|---|
| Intended Use | Antithrombin quantitation | Antithrombin quantitation |
| Analytes | Antithrombin | Antithrombin |
| Component | ||
| Reagent | ||
| Matrices | Reagent 1: Chromogenic substrate in a | |
| distilled water matrix | ||
| Reagent 2: Factor Xa - Bovine Factor | ||
| Xa in a Tris Heparin Buffer matrix | ||
| Reagent 3: Tris Heparin Buffer | Reagent 1: Chromogenic substrate in a | |
| distilled water matrix | ||
| Reagent 2: Factor Xa - Bovine Factor | ||
| Xa in a Tris Heparin Buffer matrix | ||
| Reagent 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:
| Correlation
parameter | ChromoCheck
Antithrombin Lot 1 | ChromoCheck
Antithrombin 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined lines, resembling a stylized bird or abstract form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
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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Page 2 --
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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