IGG · Formaldehyde (Formalin, Formol)
Pathology · 21 CFR 864.4010 · Class 1
Overview
| Product Code | IGG |
|---|---|
| Device Name | Formaldehyde (Formalin, Formol) |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K882268 | ZINC FORMALIN CONCENTRATE | Anatech, Ltd. | Jun 15, 1988 | SESE |
| K861201 | FORMALDEHYDE SOLUTION, 37% | Surgipath Medical Industries, Inc. | Apr 11, 1986 | SESE |
| K811794 | 37% FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | Jul 28, 1981 | SESE |
| K802506 | PLEASCENT OR FORMA-SCENT | Meridian Diagnostics, Inc. | Nov 12, 1980 | SESE |
| K792707 | PARA-PAK SAF | Meridian Diagnostics, Inc. | Jan 21, 1980 | SESE |
| K792705 | PARA-PAK FORMALIN | Meridian Diagnostics, Inc. | Jan 21, 1980 | SESE |
| K771201 | FORMALIN BUFFER CONCENTRATE | Central Labs. Assoc. MD Pathologists | Aug 22, 1977 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 3 clearances
- Anatech, Ltd. — 1 clearance
- Central Labs. Assoc. MD Pathologists — 1 clearance
- Richard-Allan Medical Ind., Inc. — 1 clearance
- Surgipath Medical Industries, Inc. — 1 clearance
