Ortho Brain Thromboplastin Diluent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843535 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ortho Diagnostic Systems, Inc. →

• What is Ortho Brain Thromboplastin Diluent used for?

  Ortho Brain Thromboplastin Diluent is a test device used in hematology for prothrombin time testing, as stated in the device description. It is designed to support laboratory testing of blood coagulation by serving as a reagent in the prothrombin time assay, which measures how long it takes for blood to clot.

• How is Ortho Brain Thromboplastin Diluent supplied and by whom?

  The device is supplied by Ortho Diagnostic Systems, Inc., as indicated in the manufacturer and supplier information within the device data. It is distributed as a test reagent for use in clinical laboratory settings under the manufacturer's label.

• Is Ortho Brain Thromboplastin Diluent a single-use or reusable device?

  While the device data does not explicitly state whether the diluent is single-use or reusable, it is classified as a test device under FDA product code GJS for prothrombin time testing. Such reagents are typically intended for single-use in vitro diagnostic procedures to ensure test accuracy and prevent contamination, based on standard clinical laboratory practice for liquid reagents.

• What regulatory pathway was used for Ortho Brain Thromboplastin Diluent?

  Ortho Brain Thromboplastin Diluent received traditional 510(k) clearance from the FDA, as specified in the AUTHORIZATIONS and DESCRIPTION fields. It was found substantially equivalent to a legally marketed device and cleared under K843535 on December 12, 1984, under regulation number 864.7750 and product code GJS.