PPM — General Purpose Reagent Class I
FDA product code PPM covers "General Purpose Reagent", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PPM
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K871533 | remel | TOMTEC GRAM STAINER DECOLORIZER | April 29, 1987 |
| K863550 | reagent laboratory | POTASSIUM HYDROXIDE 10% W/V | October 2, 1986 |
| K861890 | richard-allan medical ind | 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 | June 3, 1986 |
| K850916 | surgipath medical industries | SPRAYFIX | March 25, 1985 |
| K850737 | roseville medical laboratoriesu | TRANSPORT CULTURE MEDIUM | March 20, 1985 |
| K850845 | micro media laboratories | 0.85% SALINE | March 20, 1985 |
| K842934 | e k ind | DECOLORIZING FLUIC, ACID-ALCOHOL 3% | September 12, 1984 |
| K842863 | anatech | PRO-SOFT DEHYDRANT | August 21, 1984 |
| K842729 | e k ind | DECOLORIZING FLUID | August 3, 1984 |
| K842070 | interscience diagnostics | IDD DETERGENT | July 2, 1984 |
| K831620 | omega medical diagnostics | SODIUM HYPOCHLORITE 3% | July 28, 1983 |
| K831619 | omega medical diagnostics | SODIUM HYPOCHLORITE 7% | July 28, 1983 |
| K822326 | interscience | BLENDED DETERGENT-78N 1912-1 | October 18, 1982 |
| K822037 | volu sol medical industries | VOLU-SOL TAP WATER SUBSTITUTE | August 3, 1982 |
| K811800 | richard-allan medical ind | BLUING REAGENT | August 12, 1981 |
| K811796 | richard-allan medical ind | FORMAL ALCOHOL | July 28, 1981 |