FDA product code NSU: Instrumentation For Clinical Multiplex Test Systems
NSU is the FDA product code for instrumentation for clinical multiplex test systems. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel. FDA has cleared 12 510(k) submissions under NSU, from 10 different applicants. The average 510(k) review took 150 days (median 141). 1 De Novo request was granted under it. FDA has posted 14 recalls for NSU devices, 5 initiated in the last five years.
Definition
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de
Classification
| Field | Value |
|---|---|
| Device name | Instrumentation For Clinical Multiplex Test Systems |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for NSU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 168 |
Compare with all 510(k) review times · Search every NSU clearance
Top NSU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminex Corp. | 3 | 2014-01-10 |
| Genmark Diagnostics, Incorporated | 1 | 2017-06-09 |
| Biofire Diagnostics, LLC | 1 | 2015-01-30 |
| Liposcience | 1 | 2014-10-22 |
| Thermo Fisher Scientific (Life Technologies Holdin | 1 | 2014-05-22 |
5 more applicants have NSU clearances. See the full list in Caduvo.
Most recent NSU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163652 | Genmark Diagnostics, Incorporated | ePlex Instrument | 2017-06-09 | 168 |
| K143178 | Biofire Diagnostics, LLC | FilmArray 2.0 System | 2015-01-30 | 87 |
| K133849 | Liposcience | VANTERA CLINICAL ANALYZER | 2014-10-22 | 307 |
| K141220 | Thermo Fisher Scientific (Life Technologies Holdin | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE | 2014-05-22 | 10 |
| K133302 | Luminex Corp. | FLEXMAP 3D | 2014-01-10 | 77 |
Recalls for NSU devices
14 product recalls in 12 recall events; 5 initiated in the last five years and 6 still open. Most recent: 2025-10-22.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code NSU?
NSU is the FDA product code for instrumentation for clinical multiplex test systems. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel.
What device class is NSU?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NSU?
Across 12 cleared submissions the average was 150 days from receipt to decision (median 141).
Which companies have the most NSU clearances?
Luminex Corp. (3); Genmark Diagnostics, Incorporated (1); Biofire Diagnostics, LLC (1); Liposcience (1); Thermo Fisher Scientific (Life Technologies Holdin (1).
Have NSU devices been recalled?
Yes: 14 product recalls across 12 recall events; the most recent began 2025-10-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NSU
- Run a recall and safety report across every NSU manufacturer
- Watch product code NSU 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.
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