FDA product code NQD: Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
NQD is the FDA product code for cardiac c-reactive protein, antigen, antiserum, and control. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel. FDA has cleared 19 510(k) submissions under NQD, 3 in the last five years, from 11 different applicants. The average 510(k) review took 100 days (median 73); 100 days on average over the last three years. FDA has posted 3 recalls for NQD devices.
Definition
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Classification
| Field | Value |
|---|---|
| Device name | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5270 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NQD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 283 |
| 2022 | 1 | 490 |
| 2024 | 1 | 112 |
| 2026 | 1 | 87 |
Compare with all 510(k) review times · Search every NQD clearance
Top NQD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 5 | 2006-12-26 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2024-01-18 |
| Beckman Coulter, Inc. | 2 | 2007-06-21 |
| Roche Diagnostics Corp. | 2 | 2006-02-09 |
| Olympus America, Inc. | 2 | 2005-08-22 |
6 more applicants have NQD clearances. See the full list in Caduvo.
Most recent NQD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260026 | Roche Diagnostics | Tina-quant Cardiac high sensitivity CRP III | 2026-04-02 | 87 |
| K233242 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | 2024-01-18 | 112 |
| K212559 | Siemens Healthcare Diagnostics Products GmbH | CardioPhase® hsCRP | 2022-12-16 | 490 |
| K173833 | SENTINEL CH. SpA | CRP Vario | 2018-09-27 | 283 |
| K081294 | Siemens Healthcare Diagnostics, Inc. | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | 2008-07-29 | 83 |
Recalls for NQD devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-26.
Frequently asked questions
What is FDA product code NQD?
NQD is the FDA product code for cardiac c-reactive protein, antigen, antiserum, and control. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel.
What device class is NQD?
Class II, regulation 21 CFR 866.5270. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQD?
Across 19 cleared submissions the average was 100 days from receipt to decision (median 73).
Which companies have the most NQD clearances?
Dade Behring, Inc. (5); Siemens Healthcare Diagnostics, Inc. (2); Beckman Coulter, Inc. (2); Roche Diagnostics Corp. (2); Olympus America, Inc. (2).
Have NQD devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2016-02-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NQD
- Run a recall and safety report across every NQD manufacturer
- Watch product code NQD 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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