OLD · Internal Polymerase Chain Reaction Control, Not Assay Specific
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | OLD |
|---|---|
| Device Name | Internal Polymerase Chain Reaction Control, Not Assay Specific |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K083430 | REAL-TIME PCR INTERNAL CONTROL 2B SET | Nanogen, Inc. | Jan 15, 2009 | SESE |
Top Applicants
- Nanogen, Inc. — 1 clearance
