(76 days)
BK860038
Not Found
No
The description details a standard biochemical assay based on the Clauss method, which measures clotting time. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies are standard method comparisons.
No
This device is for the quantitative determination of fibrinogen and to accelerate coagulation of samples, which are diagnostic purposes, not therapeutic.
Yes
The device is used for the quantitative determination of fibrinogen in plasma, which indicates its use in aiding in the diagnosis or monitoring of conditions related to fibrinogen levels.
No
The device description clearly indicates it is a reagent kit used for laboratory testing, which involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For use in the quantitative determination of fibrinogen in plasma". This is a diagnostic test performed on a biological sample (plasma) outside of the body (in vitro) to provide information about a patient's health status (fibrinogen levels).
- Device Description: The description details a method for measuring fibrinogen in plasma using a chemical reaction (thrombin clotting time). This is a typical characteristic of an in vitro diagnostic assay.
- Performance Studies: The document includes performance studies comparing the device to predicate devices, which is a requirement for IVD submissions.
- Predicate Devices: The mention of predicate devices (Dade® Fibrinogen Determination Reagents kit and Dade® Thrombin Reagent) further confirms its classification as an IVD, as it's being compared to existing devices in the same category.
The second part of the intended use, "to accelerate coagulation of anticoagulated samples for immunohematology studies," also involves manipulating a biological sample outside the body for diagnostic purposes, which falls under the scope of IVD.
N/A
Intended Use / Indications for Use
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.
Product codes
KQJ
Device Description
Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.
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
Method Comparison Study Dade® Fibrinogen Determination Reagents vs. Dade® Thrombin Reagent
SHP Lot # 502587
(n=) 80
Slope 1.03
Intercept -0.063
Correlation Coefficient 0.995
SHP Lot # 502589
(n=) 80
Slope 0.946
Intercept -0.027
Correlation Coefficient 0.993
Key Metrics
Correlation Coefficient (R), Slope, Intercept
Predicate Device(s)
BK860038
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
510(k) Summary for Dade® Thrombin Reagent
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: K050928
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
June 24, 2005
| 2. | Device Name | Dade® Thrombin Reagent and Dade® Owren's Veronal Buffer |
|---|---|---|
| Classification: | Fibrinogen Determination System, Class II, 21 CFR 864.7340 | |
| Panel: | Hematology | |
| Product Code: | KQJ |
ldentification of the Legally Marketed Device: 3.
Dade® Fibrinogen Determination Reagents kit (Pre-1976) and Dade® Thrombin Reagent (BK860038)
Device Description: 4.
Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.
1
5. Device Intended Use:
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.
Medical device to which equivalence is claimed and comparison information: 6.
The modified Dade Thrombin Reagent is substantially equivalent to the currently marketed Dade® Fibrinogen Determination Reagents kit (Pre-1976) and Dade® Thrombin mancied Daoc The modified Dade Thrombin Reagent, like the current Dade Fibrinogen Determination Reagents kit is intended for use in the quantitative determination of fibrinogen in human plasma and to accelerate coagulation of anticoagulated samples for immunohematological studies.
Device Performance Characteristics: 7 .
Method Comparison Study Dade® Fibrinogen Determination Reagents vs. Dade® Thrombin Reagent
| Dade® Thrombin
Reagent | (n=) | Slope | Intercept | Correlation
Coefficient |
|---------------------------|------|-------|-----------|----------------------------|
| SHP Lot # 502587 | 80 | 1.03 | -0.063 | 0.995 |
| SHP Lot # 502589 | 80 | 0.946 | -0.027 | 0.993 |
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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 eagle with three lines representing its body and wings. The eagle faces left and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
JUN 2 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
K050928 Re:
Trade/Device Name: Dade® Thrombin Reagent Regulation Number: 21 CFR § 864.7340 Regulation Name: System, Fibrinogen Determination Regulatory Class: II Product Code: KQJ Dated: April 13, 2005 Received: April 14, 2005
Dear Ms. Dray-Lyons:
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 for are cased a a 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 or any I odeful 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 Of It Fart 6077, acceming (21 the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form arketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleate 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, If you destions on the promotion and advertising of your device, please contact the Office of In of quotions on the promise Evaluation and Safety at (240) 276-0484. Also, please note the v tro Diagnoution . "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may obtain of Scherar ne 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,
Robert Beckerh
Robert L. Becker, Jr., MD, PAD 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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Dade Behring Inc. Dade® Thrombin Reagent 510(k) Notification - Modification
Indications Statement
Device Name:
Dade® Thrombin Reagent
Indications for Use:
muleations for Goo.
For use in the quantitative determination of fibrinogen in plasma and to accelerate r or ass in the quantically ated samples for immunohematology studies.
Prescription Use
(Per 21 CFR 801 Subpart D)
Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device Evaluation and Safety
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