Hemosil Protein S Activity Assay

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

HemosIL Protein S Activity

Generic Name

Protein S IVD, kit, clotting

Model / Ref / Catalog

0020302000 EUDAMED

00020302000 GUDID

Primary DI / UDI-DI

08426950566526

Basic UDI-DI

84269505665269J

Direct Marketing DI

08426950566526

510(k) Number

K102164 ↗

FDA Product Code

GGP

EMDN Code

W0103020608 Protein s activity

GMDN Term

Protein S IVD, kit, clotting

Device Class

Class B EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 864.7290

EU market of registration

Italy

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• HemosIL Silica Clotting Time

  Class II

  FDA 510(k) K253957 Active Cleared 9 Jan 2026

• GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST 00055415005

  Class II

  GUDID on market

• GEM CVP (Calibration Validation Product) Level 4 00024001814

  Class I

  CE/IVDR IVDR 727804 Active Valid to Oct 2031 GUDID on market

• HemosIL RecombiPlasTin 2G (8 mL) 00020002950

  Class II

  CE/IVDR GUDID on market

• ChemSTAT Hematocrit Evaluator 1 00044000104

  Class II

  GUDID on market

• Coatest SP FVIII 82 4086 63

  Class II

  GUDID on market

See all devices from Instrumentation Laboratory Company →

• What is the Hemosil Protein S Activity Assay used for in a clinical setting?

  The Hemosil Protein S Activity Assay is a coagulation functional test designed to measure the functional activity of free Protein S in blood. It helps identify deficiencies in Protein S, which can affect coagulation and may be relevant in diagnosing or monitoring conditions related to blood clotting disorders. The assay works by assessing how the presence of Protein S influences the prolongation of prothrombin time in a controlled laboratory setting.

• Which analyzers are compatible with this assay, and how is it supplied?

  This assay is specifically designed for use on Instrumentation Laboratory’s ACL TOP Family analyzers. It is supplied as a reagent kit intended for laboratory testing, meaning it is not a standalone device but rather a component used within the analyzer system to perform the Protein S activity measurement.

• Is the Hemosil Protein S Activity Assay single-use or reusable, and what are its storage requirements?

  The provided data does not explicitly state whether the assay is single-use or reusable. However, as a reagent for laboratory testing, it is typically designed for multiple uses within a single batch or vial, depending on the manufacturer’s instructions. Storage requirements are not detailed in the data, but reagents like this are generally stored according to the manufacturer’s guidelines, often at refrigerated temperatures (2–8°C) and protected from light until use.

• What regulatory pathway was followed for the approval of this device, and which advisory committee was involved?

  The Hemosil Protein S Activity Assay was cleared through the FDA’s 510(k) Traditional pathway, demonstrating substantial equivalence to a predicate device. The product was reviewed by the Hematology (HE) Advisory Committee, which evaluates hematology-related devices to ensure their safety and effectiveness for clinical use in diagnosing or monitoring blood-related conditions.