FDA product code NDR: Enzyme Immunoassay, Inhibin-A

NDR is the FDA product code for enzyme immunoassay, inhibin-a. It is a Class I device, regulated under 21 CFR 862.1260 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under NDR. The average 510(k) review took 144 days (median 144). FDA has posted 3 recalls for NDR devices.

Classification

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Top NDR applicants

Most recent NDR clearances

Recalls for NDR devices

3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-21.

Frequently asked questions

What is FDA product code NDR?

NDR is the FDA product code for enzyme immunoassay, inhibin-a. It is a Class I device, regulated under 21 CFR 862.1260 and reviewed by the Clinical Chemistry panel.

What device class is NDR?

Class I, regulation 21 CFR 862.1260. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code NDR?

Across 1 cleared submissions the average was 144 days from receipt to decision (median 144).

Which companies have the most NDR clearances?

Diagnostic Systems Laboratories, Inc. (1).

Have NDR devices been recalled?

Yes: 3 product recalls across 2 recall events; the most recent began 2010-12-21.

Next steps

• Run an FDA pathway report with predicate devices for product code NDR
• Run a recall and safety report across every NDR manufacturer
• Watch product code NDR 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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