Internal Polymerase Chain Reaction Control, Not Assay Specific
The Internal Polymerase Chain Reaction Control, Not Assay Specific (product code OLD) is a Class 1 device regulated under 21 CFR 862.1660 in the Clinical Chemistry specialty (CH), exempt from premarket notification. It functions as an internal control for use in real-time PCR assays to detect systematic variation arising during extraction and amplification processes, but is not intended to monitor other real-time PCR processes. Class 1 devices are subject only to general controls, and this device is not an implant or life-sustaining.
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Basic Information
- Product Code
- OLD
- Device Class
- FDA class 1
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K083430 | REAL-TIME PCR INTERNAL CONTROL 2B SET | Jan 15, 2009 | Substantially Equivalent | Nanogen, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.