(371 days)
No
The summary describes a standard in vitro diagnostic test kit for quantitative determination of Antithrombin, with performance evaluated through correlation and reproducibility studies. There is no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No.
This device is described as an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, used as an aid in diagnosis and monitoring, not for treating a disease or condition.
Yes
The device is described as an "in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia". The phrase "aid in the diagnosis" clearly indicates its primary purpose is diagnostic.
No
The device is an in vitro diagnostic test kit, which includes reagents and likely other physical components for performing a laboratory assay, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia". This clearly indicates its use for diagnostic purposes outside of the body.
- Device Description: The description reiterates its use as an "in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma".
- Sample Type: The test is performed on "human plasma", which is a biological sample taken from the body and analyzed in vitro.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Product codes
81JBQ, JBQ
Device Description
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
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
The assay performance of Biophen Antithrombin was compared to Coamatic ® Antithrombin using plasma received from hospital on automated BCS. The Biophen Antithrombin ®2.5 & 5 રવ 510(k) # K043007 correlation was 0.99 between the results obtained with the two devices. Overall 21 samples were tested on both the devices. The intra-assay and Inter assay reproducibility's obtained for samples with variable Antithrombin concentration on ACL is given below:
| sample | AT concentration % | Intra Assay (CV %) | N | Inter-Assay (CV %) | N |
|---|---|---|---|---|---|
| 1 | 109 | 0.73% | 10 | 2.57% | 12 |
| 2 | 69 | 0.66% | 10 | 2.49% | 12 |
| 3 | 51 | 0.92% | 10 | 3.72% | 12 |
Key Metrics
Not Found
Predicate Device(s)
K 915083 Coamatic ® Antithrombin
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).
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Section Q. Biophen Antithrombin - 510(k ) Summary (Summary of Safety and Effectiveness)
Submitted by:
Hyphen Biomed 95000 Neuville sur oise. France Phone # 01 34 40 6510 Fax# 301 34 48 72 36
Contact Person:
Dr. Jean Amiral, President & Scientific Director
Summary prepared by:
14" Oct 2004
Name of the Device:
Biophen Antithrombin
Classification Name:
Antithrombin III Assay, Class II
Regulation # 864.7060
Product Code: 81JBQ
Identification of Predicate device:
K 915083 Coamatic ® Antithrombin ( Originaly named Coamatic Antithrombin)
Description of the Device/Intended use:
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
Statement of How the technological Characteristics of the Device Compare to the Predicate Device:
Biophen Antithrombin uses the same principle as the predicate Coamatio® Antithrombin and is substantially equivalent in performance, intended use and safety and effectiveness.
Summary of performance Data:
The assay performance of Biophen Antithrombin was compared to Coamatic ® Antithrombin using plasma received from hospital on automated BCS. The Biophen Antithrombin ®2.5 & 5 રવ 510(k) # K043007
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correlation was 0.99 between the results obtained with the two devices. Overall 21 samples were tested on both the devices.
The intra-assay and Inter assay reproducibility's obtained for samples with variable Antithrombin concentration on ACL is given below:
| sample | AT concentration
% | Intra Assay
(CV %) | N | Inter-Assay
(CV %) | N |
|--------|-----------------------|-----------------------|----|-----------------------|----|
| 1 | 109 | 0.73% | 10 | 2.57% | 12 |
| 2 | 69 | 0.66% | 10 | 2.49% | 12 |
| 3 | 51 | 0.92% | 10 | 3.72% | 12 |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle.
NOV - 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HYPHEN Biomed c/o Mr. Ola Anderson President Aniara Corporation 6560 Gove Court Mason, Ohio 45040
Re: K043007
Trade Name: Biophen® Antithrombin 2.5 and Biophen® Antithrombin 5 Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBQ Dated: September 14, 2005 Received: September 15, 2005
Dear Mr. Anderson:
We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 adultcration.
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). 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.
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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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
lobetz Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 043007
Device Name: Biophen ® Antithrombin 2.5 &5
Indications for Use:
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrepes of CDRH, Office of Device Eyaluation (ODE)
Josephine Bautista
Division/Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K043007