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Synthasil APTT Reagent

by Ortho Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K953981

Overview

This device is an Activated Partial Thromboplastin reagent used for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma. It utilizes synthetic lipidation technology to ensure stable product performance and excellent lot-to-lot uniformity.

It is supplied as a reagent for laboratory use in hematology testing. The device has received FDA 510(k) clearance (K953981) and is classified as a Class II medical device under regulation number 864.7925 with product code GFO.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953981 Date30 Nov 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GFO
Device Class
Class II
Regulation
21 CFR Part 864.7925
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the SYNTHASIL APTT REAGENT used for?

    The SYNTHASIL APTT REAGENT is used for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma, which helps assess the intrinsic pathway of coagulation in hematology testing.

  • How is the SYNTHASIL APTT REAGENT supplied and what technology does it use?

    It is supplied as a reagent for laboratory use and utilizes synthetic lipidation technology to ensure stable product performance and excellent lot-to-lot uniformity in APTT testing.

  • What regulatory clearance does the SYNTHASIL APTT REAGENT have?

    The device has received FDA 510(k) clearance under submission K953981 and is classified as a Class II medical device under regulation number 864.7925 with product code GFO.