Home / 510(k) Clearances / K090191

510(k) K090191

HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB by Handylab, Inc. — Product Code NJR

K090191 is an FDA 510(k) premarket notification submitted by Handylab, Inc. for the device "HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB". The FDA issued a decision of Substantially Equivalent on May 27, 2010. The device falls under product code NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test), a Class I device regulated under 21 CFR 866.3740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2010
Date Received
January 27, 2009
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.

Other clearances for product code NJR

  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack (November 7, 2018)
  • 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)

FDA data resources