BD Max GBS Assay, BD Max Instrument
FDA 510(k) K111860 · Becton, Dickinson & CO
510(k) numberK111860
Submission
- Device name
- BD Max GBS Assay, BD Max Instrument
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- June 30, 2011
- Decision date
- February 16, 2012
- 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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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was BD Max GBS Assay, BD Max Instrument cleared by the FDA?
BD Max GBS Assay, BD Max Instrument (K111860) received a 510(k) decision of Substantially Equivalent on February 16, 2012, 231 days after the submission was received.
What is the product code of K111860?
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.