ARIES GBS Assay
FDA 510(k) K162772 · Luminex Corporation
510(k) numberK162772
Submission
- Device name
- ARIES GBS Assay
- Applicant
- Luminex Corporation
Austin, TX, US - Received
- October 3, 2016
- Decision date
- December 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K173725 | NeuMoDx GBS AssayNJR · Traditional | Neumodx Molecular, Inc. | 06/26/2018SE |
| K173250 | Solana GBS AssayNJR · Traditional | Quidel Corporation | 12/21/2017SE |
| K170557 | GenePOC GBS LBNJR · Traditional | Genepoc, Inc. | 05/25/2017SE |
| 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 |
|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | 06/06/2025SE |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | 04/18/2025SE |
| K240627 | LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional | 06/04/2024SE |
| K233410 | LIAISON PLEX Respiratory Flex AssayQOF · Traditional | 03/01/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | 09/25/2019SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | 07/21/2017SE |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional | 05/02/2017SE |
| K161220 | ARIES® Flu A/B & RSV AssayOCC · Traditional | 08/02/2016SE |
Questions and answers
When was ARIES GBS Assay cleared by the FDA?
ARIES GBS Assay (K162772) received a 510(k) decision of Substantially Equivalent on December 23, 2016, 81 days after the submission was received.
What is the product code of K162772?
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.