Cleared Traditional

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

K982879 · Shield Diagnostics, Ltd. · Immunology
Oct 1998
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K982879 is an FDA 510(k) clearance for the SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on October 15, 1998, 62 days after receiving the submission on August 14, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K982879 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1998
Decision Date October 15, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

Similar Devices — MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 45
Aptiva APS IgA Reagent
K243979 · Inova Diagnostics, Inc. · Feb 2026
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329 · Phadia AB · Jun 2018
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
K162788 · Immco Diagnostics, Inc. · Jun 2017
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
K152875 · Inova Diagnostics, Inc. · Dec 2015
QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS.
K141274 · Inova Diagnostics, Inc. · Feb 2015
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · Phadia US, Inc. · Jun 2012