NeuMoDx GBS Assay
FDA 510(k) K173725 · Neumodx Molecular, Inc.
510(k) numberK173725
Submission
- Device name
- NeuMoDx GBS Assay
- Applicant
- Neumodx Molecular, Inc.
Ann Arbor, MI, US - Received
- December 5, 2017
- Decision date
- June 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
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 510(k)s with product code NJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR · Traditional | Cepheid | 09/27/2023SE |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJR · Traditional | Cepheid | 05/09/2022SE |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control PackNJR · Traditional | Diasorin Molecular, LLC | 11/07/2018SE |
| K181156 | Panther Fusion GBS AssayNJR · Traditional | Diagenode | 07/27/2018SE |
| K173250 | Solana GBS AssayNJR · Traditional | Quidel Corporation | 12/21/2017SE |
| K170557 | GenePOC GBS LBNJR · Traditional | Genepoc, Inc. | 05/25/2017SE |
| K162772 | ARIES GBS AssayNJR · Traditional | Luminex Corporation | 12/23/2016SE |
| K143312 | Portrait GBS AssayNJR · Traditional | Great Basin Corporation | 04/21/2015SE |
| K133503 | Amplivue GBS AssayNJR · Traditional | Quidel Corporation | 12/20/2013SE |
| K121539 | Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert…NJR · Traditional | Cepheid | 11/02/2012SE |
More from Cepheid
| 510(k) | Device | Decision |
|---|---|---|
| K230267 | NeuMoDx CT/NG Assay 2.0QEP · Traditional | 12/22/2023SE |
Questions and answers
When was NeuMoDx GBS Assay cleared by the FDA?
NeuMoDx GBS Assay (K173725) received a 510(k) decision of Substantially Equivalent on June 26, 2018, 203 days after the submission was received.
What is the product code of K173725?
The FDA product code is NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a Class I (low risk) device regulated under 21 CFR 866.3740.