Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
The Tetrazolium INT Dye-Diaphorase Lactate Dehydrogenase Test is a clinical chemistry device that measures LDH enzyme activity using a coupled reaction system in which diaphorase reduces a tetrazolium dye (INT) to a colored formazan product in proportion to LDH activity, used in the diagnosis of tissue injury from cardiac, hepatic, or hemolytic conditions. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CFH, regulated under 21 CFR 862.1440, within the Clinical Chemistry medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- CFH
- Device Class
- FDA class 2
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050790 | SPOTCHEM II LDH TEST | Jun 06, 2005 | Substantially Equivalent | Arkray, Inc. |
| K020484 | CARESIDE LDH | Jul 03, 2002 | Substantially Equivalent | Careside, Inc. |
| K895138 | CLINISTAT LDH REAGENT TEST | Oct 19, 1989 | Substantially Equivalent | Heraeus Kulzer, Inc. |
| K894578 | IQ LDH | Oct 17, 1989 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K880630 | LACTATE DEHYDROGENASE (LDH-L) | Mar 16, 1988 | Substantially Equivalent | Tech-Co, Inc. |
| K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET | Feb 28, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K852391 | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE | Oct 01, 1985 | Substantially Equivalent | Helena Laboratories |
| K842452 | WAKO LDH CII TEST | Aug 15, 1984 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K820768 | COLORIMETRIC LDH REAGENT SET | Apr 14, 1982 | Substantially Equivalent | Biorent Diagnostic, Inc. |
| K812836 | LDH REAGENT SET | Oct 09, 1981 | Unknown | Anco Medical Reagents & Assoc. |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent | Hycel, Inc. |
| K771343 | LDH-INT TEST | Aug 10, 1977 | Substantially Equivalent | Hycel, Inc. |
| K760009 | COLORIMETRIC DETERMINATION (LDH) | Jul 20, 1976 | Substantially Equivalent | The Dow Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.