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510(k) K222638

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems by Cepheid — Product Code NJR

K222638 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems". The FDA issued a decision of Substantially Equivalent on September 27, 2023. 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. Cepheid has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
September 1, 2022
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 by Cepheid

  • K253653 — Xpert Hemorrhagic Fever (February 20, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K250218 — Xpert® FII & FV (February 21, 2025)
  • K242071 — Xpert Xpress CoV-2/Flu/RSV plus (January 10, 2025)
  • DEN240016 — Xpert HCV; GeneXpert Xpress System (June 27, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)
  • K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert I (September 27, 2019)

Other clearances for product code NJR

  • 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)
  • K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GE (November 2, 2012)

FDA data resources