General Purpose Reagent
The General Purpose Reagent is a chemical reagent with general laboratory application used to collect, prepare, and examine specimens from the human body for diagnostic purposes, not labeled for a specific diagnostic application. It may be an individual substance or multiple substances that, when combined with an analyte-specific reagent (ASR) and other reagents, form part of an in vitro diagnostic (IVD) test system. It is classified as FDA Class 1 (Pathology specialty) under 21 CFR 864.4010, subject to general controls and exempt from Good Manufacturing Practice (GMP) requirements. Product code PPM; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPM
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871533 | TOMTEC GRAM STAINER DECOLORIZER | Apr 29, 1987 | Substantially Equivalent | Remel Co. |
| K863550 | POTASSIUM HYDROXIDE 10% W/V | Oct 02, 1986 | Substantially Equivalent | Reagent Laboratory, Inc. |
| K861890 | 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 | Jun 03, 1986 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K850916 | SPRAYFIX | Mar 25, 1985 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K850845 | 0.85% SALINE | Mar 20, 1985 | Substantially Equivalent | Micro Media Laboratories |
| K850737 | TRANSPORT CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent | Roseville Medical Laboratoriesu |
| K842934 | DECOLORIZING FLUIC, ACID-ALCOHOL 3% | Sep 12, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842863 | PRO-SOFT DEHYDRANT | Aug 21, 1984 | Substantially Equivalent | Anatech, Ltd. |
| K842729 | DECOLORIZING FLUID | Aug 03, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842070 | IDD DETERGENT | Jul 02, 1984 | Substantially Equivalent | Interscience Diagnostics, Inc. |
| K831620 | SODIUM HYPOCHLORITE 3% | Jul 28, 1983 | Substantially Equivalent | Omega Medical Diagnostics |
| K831619 | SODIUM HYPOCHLORITE 7% | Jul 28, 1983 | Substantially Equivalent | Omega Medical Diagnostics |
| K822326 | BLENDED DETERGENT-78N 1912-1 | Oct 18, 1982 | Substantially Equivalent | Interscience, Inc. |
| K822037 | VOLU-SOL TAP WATER SUBSTITUTE | Aug 03, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K811800 | BLUING REAGENT | Aug 12, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K811796 | FORMAL ALCOHOL | Jul 28, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
FEI Numbers
This FDA classification entry is associated with 258 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 258 registration numbers. Click on an entry to view related FDA registrations.