Hemosil LA Positive Control & Hemosil LA Negative Control

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 22 Oct 2026.

Trade Name

HemosIL LA Negative Control

Generic Name

Lupus anticoagulant marker IVD, control

Model / Ref / Catalog

0020012600 EUDAMED

00020012600 GUDID

Primary DI / UDI-DI

08426950513728

Basic UDI-DI

84269505137287L

Direct Marketing DI

08426950513728

510(k) Number

K113211 ↗

FDA Product Code

GGN

EMDN Code

W0103020702 Control plasma for haemostasis

GMDN Term

Lupus anticoagulant marker IVD, control

Device Class

Class B EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 864.5425

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 primary purpose of the Hemosil LA Positive and Negative Controls in a laboratory setting?

  The Hemosil LA Positive and Negative Controls are lyophilized plasma-based standards designed specifically to validate the performance of Lupus Anticoagulant (LA) assays. They help laboratories assess the precision and accuracy of their coagulation testing workflows by providing reference values for both positive (abnormal) and negative (normal) results, ensuring reliable assay functionality before patient testing.

• Are these controls intended for direct patient use, or are they meant for quality assurance in testing?

  These controls are not sterile or intended for direct patient use. Instead, they are validated for quality assurance in hematology laboratories, serving as reference standards to verify the accuracy and consistency of Lupus Anticoagulant (LA) assays before patient samples are processed. They follow standard laboratory protocols for lyophilized reagents.

• How should the Hemosil LA controls be stored, and what are the implications for their single-use nature?

  The controls are supplied as lyophilized preparations, which means they require storage under standard laboratory conditions for lyophilized reagents—typically refrigerated (2–8°C) and protected from moisture until use. Since they are designed for single-use only, each vial must be discarded after one assay run to prevent contamination and ensure accurate results.

• What regulatory pathways have these controls undergone, and how does that affect their use in clinical settings?

  The Hemosil LA Positive and Negative Controls have undergone FDA 510(k) clearance (K113211) and comply with IVDR (In Vitro Diagnostic Regulation) standards. This regulatory clearance confirms their substantial equivalence to predicate devices and ensures they meet safety, performance, and quality requirements for use as reference standards in coagulation testing. Clinicians and labs can rely on these controls as validated tools for assay validation.