# K971935: B&D Activated Clotting Time (Act) Test Tubes BD-C101 (Diatomaceous Earth) and BD-K101 (Kaolin)

- Pathway: 510(k) (Traditional)
- Applicant: B & D Corp.
- Decided: Oct 1, 1997 after 127 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913861 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913861: Hemochron (R) Kact, International Technidyne Corp. (1991) Summary page 1.
- (no number) International Technidyne Corp. FTCA510 (diatomaceous earth): named in the summary without a submission number

## Indications for use
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 aprotinin, 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.

Source page: https://510kreport.com/device/K971935
Methodology: https://510kreport.com/methodology