B&D Activated Clotting Time (ACT) test tubes are intended for use in monitoring anticoagulation effects of heparin. Heparin is commonly used during coronary bypass surgery, coronary angioplasty and several other medical/surgical procedures in order to prevent thrombus formation. B&D Kaolin ACT test tubes (BD-K101) are not sensitive to provinin, and are the appropriate ACT test tubes to monitor heparin in patients treated with the moderate levels of protease inhibitor, aprotinin (up to 180 KIU/mL). B&D ACT test tubes are for whole blood, in-vitro diagnostic use only. B&D ACT test tubes are to be used with several whole blood ACT analyzers currently available, such as Hemochron® ACT analyzers Model numbers: 400, 401, 800, 801 and 8000.

Device Description

Activated coagulation time (ACT) test tubes are used for monitoring heparin and aprotinin anticoagulation during coronary bypass surgery, coronary angioplasty and other medical/surgical procedures. These test tubes contain a clotting activator (either diatomaceous earth or kaolin), flip-top cap and a plastic insert that retains the magnet at the bottom of the test tube. Fresh whole blood is added to the test tube, it is mixed and placed into an instrument that is designed to display the activated clotting time (ACT) when the clotting is formed. This activated clotting time (ACT) timing indicates to physicians if the patient needs any anticoagulation adjustments.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly state numerical acceptance criteria in terms of a threshold value for correlation coefficients or a range for quality control plasma results before the studies were conducted. Instead, the reporting describes the achieved performance and concludes equivalence based on these results.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (BD-C101 vs. FTCA510)	Reported Device Performance (BD-K101 vs. KACT)
Correlation of Clotting Times (Fresh Whole Blood, various heparin)	High correlation coefficient demonstrating equivalence to predicate device.	Correlation coefficient = 0.999	Correlation coefficient = 0.999
Clotting Times with Quality Control Plasma (Normal & Abnormal Levels)	Values and averages "centered around the midrange specified for the Quality Control Plasma."	All values and their averages were centered around the midrange specified for the Quality Control Plasma.	All values and their averages were centered around the midrange specified for the Quality Control Plasma.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of samples (e.g., number of fresh whole blood samples or QC plasma samples) used in the testing. It mentions "four different heparin concentrations, as well as a baseline" for fresh whole blood, implying multiple tests per concentration. For QC plasma, it mentions "Normal and Abnormal levels," again implying multiple tests.
Data Provenance: The document does not specify the country of origin. The studies appear to be prospective as they were conducted to establish equivalence for the new devices, rather than analyzing existing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the summary. The studies involve measuring clotting times, which are instrument-derived values rather than interpreted by human experts in the typical "ground truth" sense for diagnostic imaging.

4. Adjudication Method for the Test Set

This is not applicable as the test results are direct measurements from an instrument (Hemochron® 8000) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the equivalence of the device to a predicate device, not on the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in spirit. The studies described are standalone performance evaluations of the device (test tubes) when used with an existing ACT analyzer (Hemochron® 8000). The device itself, in conjunction with the analyzer, provides the activated clotting time without human interpretation being the primary output being evaluated for accuracy.

7. The Type of Ground Truth Used

The ground truth implicitly used is the measurement provided by the predicate device (FTCA510 or KACT) when run on the same instrument (Hemochron® 8000). The goal was to show that the new devices' measurements correlated highly and produced similar results, especially with QC plasma that has predetermined "midrange" values. Essentially, the predicate device's performance, which is already accepted, serves as the standard.

8. The Sample Size for the Training Set

This product is a medical device (test tube) and not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set as this is not an AI/ML device, this question is not applicable.

Summary

{0}------------------------------------------------

1111111100

510(k) Summary

Page 1 of 2

Mav 20, 1997 Prepared:

Submitted by:

OCT - 1 1997

Hardeep Dhaliwal B&D Corp. 14 Michael Drive Metuchen, NJ 0840-2223 (908) 549-8210

Device Name

Classification Name: Activated Whole Blood Clotting Time Test Activated Whole Blood Clotting Time Test Common/Usual Name: B&D Activated Clotting Time (ACT) test tubes Proprietary Name: BD-C101 (diatomaceous earth) and BD-K101(kaolin)

Predicate Device

International Technidyne Corp. FTCA510 (diatomaceous earth) - a preamendment device, marketed since 1970, and KACT (K913861).

Device Description

Statement of Intended Use

The sole intended use of this product is to monitor heparin and aprotinin anticoagulation in whole blood. Typically, heparin and aprotinin therapy are commonly used during coronary bypass surgery, coronary angioplasty ands several other medical/surgical procedures.

Summary of Technological Characteristics

Both the predicate device (FTCA510) and BD-C101 contain diatomaceous earth as the activato. Composition of the test tubes are glass test tubes 13 x 100 mm, polyethylene flip-top caps and inserts, and ceramic magnets.

Both the predicate device (KACT) and BD-K101 contain kaolin as the activator. Composition of the test tubes are glass tubes 13 x 100 mm, polyethylene flip-top caps and inserts, and ceramic magnets.

{1}------------------------------------------------

510(k) Summary

Summary of Performance Data

To establish equivalence, the diatomaceous earth activated tubes (FTCA510 and BD-101) were tested two ways. First, clotting times were compared for fresh whole blood with four different heparin concentrations, as well as a baseline. The Celite® test tubes were run on Hemochron® 8000 according to the manufacturers instructions (International Technidyne Corp.). The correlation coefficient was 0.999.

Second, clotting time was tested using Hemochron Quality Control Plasma (CPL2) at Normal and Abnormal levels. All values and their averages were centered around the midrange specified for the Quality Control Plasma.

The kaolin activated tubes (KACT and BD-K101) were tested similarly with different levels of heparin. The correlation coefficient was 0.999.

Clotting time for the kaolin tubes using Hemochron Quality Control Plasma (CPL2) at Normal and Abnormal was also determined. All values and their averages were centered around the midrange specified for the Quality Control Plasma.

It was concluded that Hemochron FTCA510 and BD-C101 are equivalent in measuring the clotting time of fresh whole blood, fresh whole blood with different levels of heparin, and Hemochron Quality Control Plasma at Normal and Abnormal levels.

It was concluded that Hemochron KACT and BD-K101 are equivalent in measuring the clotting time of fresh whole blood, fresh whole blood with different levels of heparin, and Hemochron Quality Control Plasma at Normal and Abnormal levels.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, forming a human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Hardeep Dhaliwal President B&D Corporation 14 Michael Drive Metuchen, New Jersey 08840

OCT - 1 1997

Re : K971935 B&D Activated Clotting Time Test Tubes BD-C101 II Requlatory Class: Product Code: JBP July 17, 1997 Dated: Received: July 23, 1997

Dear Mr. Dhaliwal:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market 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, Drug, 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, labeling, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 Litman

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): K971935

Device Name: R&D Activated Clotting Time Test Tubes - BD-C101 (Celite) & BD-K101 (Kaoli Indications For Use:

Modify the intended use to reflect the correct function of aprotinin. Request 1.

page 6 of the submission has been modified as follows: Response:

Intended use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	97935

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
---------------------------------------	----	----------------------

(Optional Format 1-2-96)

『

Regulation Number and Section

§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).