(88 days)
The BC Thrombin Reagent is intended 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.
The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).
The provided document is a 510(k) summary for the BC Thrombin Reagent. This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive acceptance criteria and a standalone study for novel device performance. However, I can extract the relevant information from the "Comparative Analysis" and "Precision" sections to address your request as much as possible within the context of this submission.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (BC Thrombin Reagent vs. Predicate) |
|---|---|---|
| Correlation | High correlation with predicate device | Correlation coefficient: 0.93 |
| Agreement (Slope) | Slope close to 1.0 (indicating proportional agreement) | Slope: 1.48 |
| Agreement (Y-intercept) | Y-intercept close to 0 (indicating absence of systematic bias) | Y-intercept: -5.5 |
| Precision (Within-run) | Low variability (e.g., <10% CV) | Ranged from 2.2% to 6.2% |
| Precision (Total) | Low variability (e.g., <10% CV) | Ranged from 3.8% to 7.4% |
Note: The document does not explicitly state numerical acceptance criteria for correlation, slope, or Y-intercept. The criteria are implicitly derived from the goal of demonstrating substantial equivalence to the predicate device. For precision, the reported values are within typically acceptable ranges for IVD assays.
2. Sample size used for the test set and the data provenance
- Sample size for comparative analysis: 67 patients.
- Data provenance: The document does not specify the country of origin of the data. It states the samples were from "normal blood donors, patients undergoing heparin therapy, patients with increased fibrin degradation products," which implies they were collected for the purpose of this comparative study, thus being prospective data for this specific comparison, although the samples themselves might have been collected over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a comparative study comparing a new device to a predicate, the "ground truth" is typically established by the predicate device's measurement. The document does not describe any independent adjudication or expert panel to establish a separate ground truth.
4. Adjudication method for the test set
This information is not provided and is not applicable in this context. The study compares the new device's results directly against the predicate device's results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- A MRMC study was not done.
- This is an in vitro diagnostic (IVD) reagent, not an AI-assisted diagnostic imaging or interpretation device. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A standalone performance study was not explicitly detailed as a separate "algorithm only" study. The comparative analysis with the predicate device served as the primary performance demonstration. The precision study can be considered a standalone performance assessment of the reagent's inherent variability.
7. The type of ground truth used
The "ground truth" for the comparative analysis was the results obtained from the predicate device (Behring Test Thrombin Reagent). The study's purpose was to show that the new reagent performs similarly to the established legal predicate.
8. The sample size for the training set
The document does not mention a training set. This is likely because the BC Thrombin Reagent is an IVD reagent, not a machine learning or AI-based device that typically requires a training set. Its performance is evaluated through direct chemical and analytical comparison.
9. How the ground truth for the training set was established
As there is no mention of a training set, this information is not applicable.
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11
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For BC Thrombin Reagent
1. Manufacturer and Contact Information:
| Manufacturer: | Behring Diagnostics GmbHP.O. Box 114935001 Marburg, Germany |
|---|---|
| Contact Information: | Paul RogersBehring Diagnostics Inc.3403 Yerba Buena RoadP.O. Box 49013San Jose, CA 95161-9013Tel: 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.
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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)
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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 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.
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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
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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)
§ 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).