Cleared Traditional

Optilite IgA CSF Kit

K183151 · The Binding Site Group , Ltd. · Immunology
Jan 2019
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K183151 is an FDA 510(k) clearance for the Optilite IgA CSF Kit, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on January 23, 2019, 70 days after receiving the submission on November 14, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K183151 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2018
Decision Date January 23, 2019
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 60
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · Siemens Healthcare Diagnostics Products GmbH · Dec 2023
Immunoglobulin G (IgG)
K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Aug 2023
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · The Binding Site Group , Ltd. · Sep 2019
Optilite IgA Kit
K191985 · The Binding Site Group , Ltd. · Aug 2019
Optilite IgM Kit
K191635 · The Binding Site Group , Ltd. · Jul 2019
Human IgM Kit for use on SPAPlus
K191465 · The Binding Site Group , Ltd. · Jun 2019