DPA · Apparatus, General Use, Thin Layer Chromatography
Clinical Chemistry · 21 CFR 862.2270 · Class 1
Overview
| Product Code | DPA |
|---|---|
| Device Name | Apparatus, General Use, Thin Layer Chromatography |
| Regulation | 21 CFR 862.2270 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| GMP Exempt | Yes |
Identification
A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. Particular components of TLC systems,i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904326 | DE-TOX TUBES A AND DE-TOX TUBES B | Dyna-Tek Industries | Jan 17, 1991 | SESE |
| K884176 | CHROMATOGRAPHY KIT | Gelman Sciences, Inc. | Apr 4, 1989 | SESE |
| K791431 | TECHNICON FAST-LC SYS. FOR THEOPHYLLINE | Technicon Instruments Corp. | Oct 11, 1979 | SESE |
| K770765 | REAGENT SET, RENORPACE | G.D. Searle and Co. | Jun 24, 1977 | SESE |
| K760908 | MINIATURE ASCENDING PAPER CHROMATO- | Ackerman Nuclear, Inc. | Nov 19, 1976 | SESE |
Top Applicants
- Ackerman Nuclear, Inc. — 1 clearance
- Dyna-Tek Industries — 1 clearance
- G.D. Searle and Co. — 1 clearance
- Gelman Sciences, Inc. — 1 clearance
- Technicon Instruments Corp. — 1 clearance
