KEM · Agent, Clearing
Pathology · 21 CFR 864.4010 · Class 1
Overview
| Product Code | KEM |
|---|---|
| Device Name | Agent, Clearing |
| Regulation | 21 CFR 864.4010 |
| Device Class | Class 1 |
| Review Panel | Pathology |
| GMP Exempt | Yes |
Identification
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).
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 the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881282 | XYLENE | Anatech, Ltd. | Apr 5, 1988 | SESE |
| K874461 | HEMO-SOL | Chem Pharm, Inc. | Dec 4, 1987 | SESE |
| K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 | Helena Laboratories | May 6, 1986 | SESE |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | Jan 7, 1986 | SESE |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | Oct 22, 1985 | SESE |
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | Oct 22, 1985 | SESE |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | Aug 21, 1984 | SESE |
| K842721 | LIMONENE | E K Ind., Inc. | Aug 3, 1984 | SESE |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | Aug 12, 1983 | SESE |
| K832011 | AMERI CLEAR | Stephens Scientific | Aug 12, 1983 | SESE |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | Mar 24, 1983 | SESE |
| K822784 | HEMO-DE | Pmp Industries | Nov 5, 1982 | SESE |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | Oct 29, 1981 | SESE |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | Oct 29, 1981 | SESE |
| K811798 | CLEAR-RITE | Richard-Allan Medical Ind., Inc. | Jul 28, 1981 | SESE |
Top Applicants
- Richard-Allan Medical Ind., Inc. — 5 clearances
- Lerner Laboratories, Inc. — 2 clearances
- Anatech, Ltd. — 2 clearances
- Surgipath Medical Industries, Inc. — 1 clearance
- Stephens Scientific — 1 clearance
