Simplexa GBS Direct, Simplexa GBS Positive Control Pack
FDA 510(k) K182467 · Diasorin Molecular, LLC
510(k) numberK182467
Submission
- Device name
- Simplexa GBS Direct, Simplexa GBS Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
Cypress, CA, US - Received
- September 10, 2018
- Decision date
- November 7, 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.
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| 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 |
| 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 |
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| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | 12/23/2025SE |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional | 10/30/2025SE |
| K220963 | Simplexa COVID-19 & Flu A/B DirectQOF · Traditional | 03/17/2023SE |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackQDZ · Traditional | 11/05/2022SE |
| K212147 | Simplexa COVID-19 DirectQQX · Traditional | 09/13/2022SE |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | 08/22/2020SE |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI · Traditional | 11/26/2019SE |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO · Traditional | 05/13/2019SE |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ · Special | 12/19/2018SE |
Questions and answers
When was Simplexa GBS Direct, Simplexa GBS Positive Control Pack cleared by the FDA?
Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467) received a 510(k) decision of Substantially Equivalent on November 7, 2018, 58 days after the submission was received.
What is the product code of K182467?
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.