FDA product code OLD: Internal Polymerase Chain Reaction Control, Not Assay Specific
OLD is the FDA product code for internal polymerase chain reaction control, not assay specific. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under OLD. The average 510(k) review took 57 days (median 57).
Definition
Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
Classification
| Field | Value |
|---|---|
| Device name | Internal Polymerase Chain Reaction Control, Not Assay Specific |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OLD clearance
Top OLD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nanogen, Inc. | 1 | 2009-01-15 |
Most recent OLD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083430 | Nanogen, Inc. | REAL-TIME PCR INTERNAL CONTROL 2B SET | 2009-01-15 | 57 |
Recalls for OLD devices
openFDA lists no recalls for product code OLD.
Frequently asked questions
What is FDA product code OLD?
OLD is the FDA product code for internal polymerase chain reaction control, not assay specific. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is OLD?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OLD?
Across 1 cleared submissions the average was 57 days from receipt to decision (median 57).
Which companies have the most OLD clearances?
Nanogen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLD
- Run a recall and safety report across every OLD manufacturer
- Watch product code OLD 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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