Home / 510(k) Clearances / K022504

510(k) K022504

IDI-STREP B ASSAY by Infectio Diagnostic, Inc. — Product Code NJR

K022504 is an FDA 510(k) premarket notification submitted by Infectio Diagnostic, Inc. for the device "IDI-STREP B ASSAY". The FDA issued a decision of Substantially Equivalent on November 18, 2002. 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
November 18, 2002
Date Received
July 29, 2002
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