# Internal  Polymerase Chain Reaction  Control, Not Assay Specific
> **Product code: OLD** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1660
## Classification
- **FDA Product Code:** OLD
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1660
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OLD)
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