OIW · Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Clinical Toxicology · 21 CFR 862.3100 · Class 2
Overview
| Product Code | OIW |
|---|---|
| Device Name | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Classification Rationale
Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | Mar 15, 2018 | SESE |
| K120489 | TISSUE OF ORIGIN TEST KIT FFPE | Pathwork Diagnostics, Inc. | May 17, 2012 | SESE |
| K092967 | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | Pathwork Diagnostics | Jun 8, 2010 | SESE |
| K080896 | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST | Pathwork Diagnostics, Inc. | Jul 30, 2008 | SESU |
Top Applicants
- Pathwork Diagnostics, Inc. — 2 clearances
- Cancer Genetics, Inc. — 1 clearance
- Pathwork Diagnostics — 1 clearance
