510(k) K182467

Simplexa GBS Direct, Simplexa GBS Positive Control Pack by Diasorin Molecular, LLC — Product Code NJR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 7, 2018
Date Received: September 10, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class: Class I
Regulation Number: 866.3740
Review Panel: MI
Submission Type

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.

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Other clearances for product code NJR

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K181156 — Panther Fusion GBS Assay (July 27, 2018)
K173725 — NeuMoDx GBS Assay (June 26, 2018)
K173250 — Solana GBS Assay (December 21, 2017)
K170557 — GenePOC GBS LB (May 25, 2017)
K162772 — ARIES GBS Assay (December 23, 2016)
K143312 — Portrait GBS Assay (April 21, 2015)
K133503 — AMPLIVUE GBS ASSAY (December 20, 2013)
K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GE (November 2, 2012)