Colorimetric Method, Triglycerides
FDA product code JGY · Class I (low risk) · 21 CFR 862.1705 · Clinical Chemistry
22510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Abaxis, Inc. 2
- Polymer Technology Systems, Inc. 2
- Data Medical Associates, Inc. 2
- Heraeus Kulzer, Inc. 1
- Derma Media Lab., Inc. 1
- Schiapparelli Biosystems, Inc. 1
- Instrumentation Laboratory CO 1
- Cholestech Corp. 1
- Enzyme Technology, Inc. 1
- Sigma Diagnostics, Inc. 1
- Dade, Baxter Travenol Diagnostics, Inc. 1
- Trace Scientific , Ltd. 1
- Seppim, Inc. 1
- Syn-Kit, Inc. 1
- Gilford Diagnostics 1
- Reagents Applications, Inc. 1
- Volu Sol Medical Industries 1
- Worthington Diagnostic Systems 1
- Pierce Chemical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120664 | Piccolo Trglycerides-Capillary Test SystemJGY · Traditional | Abaxis, Inc. | 04/24/2012SE |
| K023639 | Piccolo Triglycerides Test SystemJGY · Traditional | Abaxis, Inc. | 01/24/2003SE |
| K000586 | Bioscanner Triglycerides Test StripsJGY · Traditional | Polymer Technology Systems, Inc. | 07/03/2000SE |
| K991894 | Bioscanner Triglycerides Test StripsJGY · Traditional | Polymer Technology Systems, Inc. | 05/24/2000SE |
| K971005 | TriglyceridesJGY · Traditional | Derma Media Lab., Inc. | 04/21/1997SE |
| K954187 | Triglycerides ReagentJGY · Traditional | Schiapparelli Biosystems, Inc. | 10/23/1995SE |
| K941063 | DNA Triglyceride ProcedureJGY · Traditional | Data Medical Associates, Inc. | 07/20/1994SE |
| K931116 | Il Test(Tm) TriglycerideJGY · Traditional | Instrumentation Laboratory CO | 03/28/1994SE |
| K914033 | Cholestech Lipid Monitor Syst, Triglycerides TestJGY · Traditional | Cholestech Corp. | 09/27/1991SE |
| K905226 | Triglyceride (Gpo) Reagent, UniversalJGY · Traditional | Enzyme Technology, Inc. | 12/11/1990SE |
| K902202 | Dma Triglyceride (Gpo) ProcedureJGY · Traditional | Data Medical Associates, Inc. | 07/31/1990SE |
| K894063 | Triglyceride (Gpo) Trinder ReagentJGY · Traditional | Sigma Diagnostics, Inc. | 09/07/1989SE |
| K885134 | Clinistat Triglycerides Reagent TestJGY · Traditional | Heraeus Kulzer, Inc. | 02/10/1989SE |
| K860731 | Triglycerides Reagent (Int, Colorimetric)JGY · Traditional | Trace Scientific , Ltd. | 04/07/1986SE |
| K832460 | Triglyceride Reagent-Trinder-GpoJGY · Traditional | Seppim, Inc. | 09/12/1983SE |
| K821106 | Triglyzyme V EikenJGY · Traditional | Syn-Kit, Inc. | 05/05/1982SE |
| K801012 | Triglyceride Reagent (Color)JGY · Traditional | Gilford Diagnostics | 05/14/1980SE |
| K800551 | Triglycerides Test (500NM)JGY · Traditional | Reagents Applications, Inc. | 03/25/1980SE |
| K792414 | Elvi TriglycerideJGY · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K791962 | Worthington Triglycerides Reagent SetJGY · Traditional | Worthington Diagnostic Systems | 11/05/1979SE |
| K780825 | Triglyceride C-37 Rapid Stat KitJGY · Traditional | Pierce Chemical Co. | 05/26/1978SE |
| K761283 | Tri-Con Triglyceridge ReagentsJGY · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 02/24/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1826-2025 Class II | ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1825-2025 Class II | ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |