Olive Oil Emulsion (Turbidimetric), Lipase
The Olive Oil Emulsion Turbidimetric Lipase Test is a clinical chemistry device that measures lipase enzyme activity by monitoring the turbidity change as lipase hydrolyzes an olive oil emulsion substrate, producing a clearing of the emulsion proportional to lipase concentration, used in the diagnosis of acute pancreatitis and other pancreatic disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CET, regulated under 21 CFR 862.1465, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CET
- Device Class
- FDA class 1
- Regulation Number
- 862.1465
- 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 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970124 | LIPASE REAGENT SET (COLIPASE METHOD) | Mar 06, 1997 | Substantially Equivalent | Teco Diagnostics |
| K940457 | LIPASE REAGENT SYSTEM | Jun 02, 1994 | Substantially Equivalent | Medical Diagnostic Technologies, Inc. |
| K915706 | LIPASE REAGENT SET | Feb 18, 1992 | Substantially Equivalent | Tech Intl. Co. |
| K901858 | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST | Jun 12, 1990 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K893718 | DELTATEST (R) LIPASE II | Sep 28, 1989 | Substantially Equivalent | Electro-Nucleonics, Inc. |
| K885078 | LIPASE SR LIQUID STABLE REAGENT SET | Mar 13, 1989 | Substantially Equivalent | Medical Analysis Systems, Inc. |
| K864438 | BECKMAN EPSILON(TM) LIPASE TEST KIT | Mar 12, 1987 | Substantially Equivalent | Beckman Instruments, Inc. |
| K862440 | PARAMAX LIPASE REAGENT | Aug 04, 1986 | Substantially Equivalent | American Dade |
| K844240 | ENZYGNOST LIPASE TEST | Feb 12, 1985 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Apr 18, 1983 | Substantially Equivalent | Nuclear Diagnostics, Inc. |
| K812794 | LIPASE | Oct 20, 1981 | Substantially Equivalent | Pointe Scientific, Inc., |
| K792289 | LIPASE TEST KIT | Dec 18, 1979 | Substantially Equivalent | Mallinckrodt Critical Care |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Nov 27, 1979 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
| K790796 | LIPASE REAGENT SET | Jul 17, 1979 | Substantially Equivalent | Alta Diagnostics, Inc. |
| K770364 | ACA LIPASE ANALYTICAL TEST PACK | Apr 15, 1977 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.