Cleared Traditional

CAPTIA MEASLES IGM

K140455 · Trinity Biotech USA · Microbiology
May 2014
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K140455 is an FDA 510(k) clearance for the CAPTIA MEASLES IGM, a Enzyme Linked Immunoabsorbent Assay, Rubeola Igm (Class I — General Controls, product code PCL), submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on May 22, 2014, 87 days after receiving the submission on February 24, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3520.

Submission Details

510(k) Number K140455 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2014
Decision Date May 22, 2014
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PCL — Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3520
Definition The Qualitative Detection Of Measles Specific Igm Antibodies In Serum Or Plasma.