Last synced on 2 December 2022 at 11:04 pm

Internal Polymerase Chain Reaction Control, Not Assay Specific

Page Type
Product Code
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
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1660 Quality control material (assayed and unassayed)

§ 862.1660 Quality control material (assayed and unassayed).

(a) Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

(b) Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 FR 71796, Dec. 30, 2019]

Internal Polymerase Chain Reaction Control, Not Assay Specific

Page Type
Product Code
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
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1660 Quality control material (assayed and unassayed)

§ 862.1660 Quality control material (assayed and unassayed).

(a) Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

(b) Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 FR 71796, Dec. 30, 2019]