(88 days)
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Not Found
No
The device is a reagent for a laboratory test and the description focuses on chemical components and performance metrics typical of such reagents, with no mention of AI or ML.
No
The device is a reagent used for diagnostic testing (determination of thrombin time) and monitoring, not for treating a disease or condition.
Yes
The device is intended for the "determination of the thrombin time in human plasma," which is used for "monitoring of heparin therapy," "monitoring of fibrinolysis therapy," "screening of disorders of fibrin formation," and "differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders." These are all diagnostic applications.
No
The device description clearly states the device consists of lyophilized bovine thrombin, bovine albumin, and buffer solution, which are physical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "determination of the thrombin time in human plasma." This is a diagnostic test performed on a biological sample (plasma) outside of the body (in vitro).
- Device Description: The device is a reagent (lyophilized bovine thrombin, bovine albumin, and buffer solution) used in a laboratory setting to perform the test.
- Anatomical Site: The test is performed on "human plasma," which is a biological sample.
- Performance Studies: The document describes performance studies comparing the device to a predicate device and evaluating precision, which are typical for IVD submissions.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma.
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
- The monitoring of heparin therapy. ●
- · The monitoring of fibrinolysis therapy.
- The screening of disorders of fibrin formation. .
- The differentiating between a heparin-induced prolongation of the thrombin time and fibrin . formation disorders.
Product codes (comma separated list FDA assigned to the subject device)
GJA
Device Description
The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES). This is similar to the Behring Test Thrombin Reagent, the predicate device, which consists of lyophilized bovine thrombin and bovine albumin, and HEPES buffer solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis: A total of 67 patients (normal blood donors, patients undergoing heparin therapy, patients with increased fibrin degradation products) were tested with the BC Thrombin Reagent and compared with the predicate device. Regression analysis of the test results gave a correlation coefficient of 0.93, a slope of 1.48, and a y-intercept of -5.5.
Precision: Precision studies were performed following the NCCLS EP5 guideline using three plasma samples (two in the normal range and one in the pathological range). The within-run precision ranged from 2.2% to 6.2%. The total precision ranged from 3.8 to 7.4%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Behring Test Thrombin Reagent
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
§ 864.7875 Thrombin time test.
(a)
Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo with the word "BEHRIN" in bold, uppercase letters. Below the word is a signature in cursive. The logo is contained within a rectangular box.
11
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For BC Thrombin Reagent
1. Manufacturer and Contact Information:
| Manufacturer: | Behring Diagnostics GmbH
P.O. Box 1149
35001 Marburg, Germany |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Paul Rogers
Behring Diagnostics Inc.
3403 Yerba Buena Road
P.O. Box 49013
San Jose, CA 95161-9013
Tel: 408-239-2000 |
2. Device Classification Name:
The BC Thrombin Reagent is a Class II device and has a classification name of thrombin time test (21 CFR §864.7875).
3. Intended Use:
BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma.
4. Device Description and Characteristics:
The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES). This is similar to the Behring Test Thrombin Reagent, the predicate device, which consists of lyophilized bovine thrombin and bovine albumin, and HEPES buffer solution.
Comparative Analysis: A total of 67 patients (normal blood donors, patients undergoing heparin therapy, patients with increased fibrin degradation products) were tested with the BC Thrombin Reagent and compared with the predicate device. Regression analysis of the test results gave a correlation coefficient of 0.93, a slope of 1.48, and a y-intercept of -5.5.
Precision: Precision studies were performed following the NCCLS EP5 guideline using three plasma samples (two in the normal range and one in the pathological range). The within-run precision ranged from 2.2% to 6.2%. The total precision ranged from 3.8 to 7.4%.
5. Substantial Equivalence:
Behring Diagnostics Inc. considers the BC Thrombin Reagent to be substantially equivalent to the Behring Test Thrombin Reagent in terms of intended use, reagent composition, and overall performance characteristics.
1
510(k) Number (if known):
BC Thrombin Reagent Device Name:
Indications For Use:
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
- The monitoring of heparin therapy. ●
- · The monitoring of fibrinolysis therapy.
- The screening of disorders of fibrin formation. .
- The differentiating between a heparin-induced prolongation of the thrombin time and fibrin . formation disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
yreus
(Divisio
Divisiony Devices
OR
Divisio:
510(k) K97
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 9 1997
Paul L. Rogers, Jr. Senior Manager of Regulatory Affairs Behring Diagnostics ..................... P.O. Box 49013 San Jose, California 95161-9013
Re : K970645 BC Thrombin Reagent Regulatory Class: II Product Code: GJA April 9, 1997 Dated: April 10, 1997 Received:
Dear Mr. Rogers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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
510(k) Number (if known):
Device Name: BC Thrombin Reagent
Indications For Use:
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in: ---------
- The monitoring of heparin therapy. .
- The monitoring of fibrinolysis therapy. .
- . The screening of disorders of fibrin formation.
- The differentiating between a heparin-induced prolongation of the thrombin time and fibrin . formation disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cyprus
(Division
Division
Devices
510(k) K970645
Prescription Use __
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)