FDA product code NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
NJR is the FDA product code for nucleic acid amplification assay system, group b streptococcus, direct specimen test. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under NJR, 2 in the last five years, from 12 different applicants. The average 510(k) review took 171 days (median 122). FDA has posted 11 recalls for NJR devices, 4 initiated in the last five years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for NJR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 81 |
| 2018 | 3 | 116 |
| 2022 | 1 | 535 |
| 2023 | 1 | 391 |
Top NJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid | 5 | 2023-09-27 |
| Quidel Corporation | 2 | 2017-12-21 |
| Meridian Bioscience, Inc. | 2 | 2012-05-01 |
| Diasorin Molecular, LLC | 1 | 2018-11-07 |
| Diagenode | 1 | 2018-07-27 |
7 more applicants have NJR clearances. See the full list in Caduvo.
Most recent NJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222638 | Cepheid | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | 2023-09-27 | 391 |
| K203429 | Cepheid | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | 2022-05-09 | 535 |
| K182467 | Diasorin Molecular, LLC | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | 2018-11-07 | 58 |
| K181156 | Diagenode | Panther Fusion GBS Assay | 2018-07-27 | 87 |
| K173725 | Neumodx Molecular, Inc. | NeuMoDx GBS Assay | 2018-06-26 | 203 |
Recalls for NJR devices
11 product recalls in 11 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2025-10-07.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NJR?
NJR is the FDA product code for nucleic acid amplification assay system, group b streptococcus, direct specimen test. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is NJR?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NJR?
Across 18 cleared submissions the average was 171 days from receipt to decision (median 122).
Which companies have the most NJR clearances?
Cepheid (5); Quidel Corporation (2); Meridian Bioscience, Inc. (2); Diasorin Molecular, LLC (1); Diagenode (1).
Have NJR devices been recalled?
Yes: 11 product recalls across 11 recall events; the most recent began 2025-10-07.
Next steps
- Run an FDA pathway report with predicate devices for product code NJR
- Run a recall and safety report across every NJR manufacturer
- Watch product code NJR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.