FDA product code NDY: Test, Cystatin C
NDY is the FDA product code for test, cystatin c. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel. FDA has cleared 22 510(k) submissions under NDY, 1 in the last five years, from 17 different applicants. The average 510(k) review took 126 days (median 92); 259 days on average over the last three years. FDA has posted 4 recalls for NDY devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Cystatin C |
| Device class | Class II |
| Regulation | 21 CFR 862.1225 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NDY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 32 |
| 2018 | 1 | 31 |
| 2025 | 1 | 259 |
Compare with all 510(k) review times · Search every NDY clearance
Top NDY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories | 3 | 2012-03-30 |
| Dade Behring, Inc. | 3 | 2007-01-22 |
| Gentian AS | 2 | 2008-08-20 |
| SENTINEL CH. SpA | 1 | 2025-05-16 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2018-05-25 |
12 more applicants have NDY clearances. See the full list in Caduvo.
Most recent NDY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242585 | SENTINEL CH. SpA | Cystatin C | 2025-05-16 | 259 |
| K181082 | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | 2018-05-25 | 31 |
| K171072 | Siemens Healthcare Diagnostics Products GmbH | N Latex Cystatin C; N Protein Standard UY | 2017-05-12 | 32 |
| K161817 | Roche Diagnostics Operations (Rdo) | Tina-quant Cystatin C Gen.2 | 2016-07-27 | 26 |
| K141143 | Roche Diagnostics | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | 2014-07-17 | 76 |
Recalls for NDY devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-06-07.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code NDY?
NDY is the FDA product code for test, cystatin c. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel.
What device class is NDY?
Class II, regulation 21 CFR 862.1225. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDY?
Across 22 cleared submissions the average was 126 days from receipt to decision (median 92).
Which companies have the most NDY clearances?
Diazyme Laboratories (3); Dade Behring, Inc. (3); Gentian AS (2); SENTINEL CH. SpA (1); Siemens Healthcare Diagnostics, Inc. (1).
Have NDY devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-06-07.
Next steps
- Run an FDA pathway report with predicate devices for product code NDY
- Run a recall and safety report across every NDY manufacturer
- Watch product code NDY 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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