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U.S. Department of Health and Human Services

Product Classification

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Device internal polymerase chain reaction control, not assay specific
Regulation Description Quality control material (assayed and unassayed).
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.
Physical State It is a nonsense, non-specific deoxyribonucleic acid (DNA) sequence cloned into a plasmid vector and supplied in a tris ethylenediaminetetraacetic acid buffer.
Technical Method The internal control template is a synthetic deoxyribonucleic acid (DNA) sequence that can be added to samples prior to nucleic acid extraction. With the addition of specific primer and probe sets, it is then amplified along with the target DNA sequence during the real-time polymerase chain reaction (PCR) process.
Target Area It is for in vitro diagnostic tests.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOLD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.1660
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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