Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert INFINITY-48 System (900-XXXX)
FDA 510(k) K121539 · Cepheid
510(k) numberK121539
Submission
- Device name
- Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert INFINITY-48 System (900-XXXX)
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- May 24, 2012
- Decision date
- November 2, 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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| K173725 | NeuMoDx GBS AssayNJR · Traditional | Neumodx Molecular, Inc. | 06/26/2018SE |
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| 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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| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
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Questions and answers
When was Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert INFINITY-48 System (900-XXXX) cleared by the FDA?
Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert INFINITY-48 System (900-XXXX) (K121539) received a 510(k) decision of Substantially Equivalent on November 2, 2012, 162 days after the submission was received.
What is the product code of K121539?
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.