Amphetamines Micro-plate EIA
by Solarcare Technologies Corp, Inc.
510(k) K935573
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935573 | Date14 Jul 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DKZ
- FDA applicant
- Solarcare Technologies Corp,Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
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.
The device is classified as an Enzyme Immunoassay for amphetamine under product code DKZ and regulation number 862.3100. It received FDA 510(k) clearance (K935573) on July 14, 1995, as substantially equivalent to a legally marketed device. The device is manufactured by Solarcare Technologies Corp, Inc. and is intended for use in clinical toxicology settings.
Other devices from Solarcare Technologies Corp, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the AMPHETAMINES MICRO-PLATE EIA used for?
This device measures amphetamine levels in plasma and urine specimens to assist in diagnosing amphetamine use or overdose, guiding treatment decisions, and monitoring therapeutic drug levels to ensure appropriate patient care in clinical toxicology environments.
How is the AMPHETAMINES MICRO-PLATE EIA supplied and what is its intended use setting?
The device is supplied as a micro-plate based enzyme immunoassay test system intended for use in clinical toxicology laboratories where quantitative detection of amphetamine in biological samples is required for patient assessment and management.
What regulatory pathway was used for the AMPHETAMINES MICRO-PLATE EIA and what does it indicate?
The device received FDA 510(k) clearance under submission K935573 on July 14, 1995, demonstrating it is substantially equivalent to a legally marketed predicate device, which allows its commercial distribution in the United States for the intended use.