Starch-Dye Bound Polymer, Amylase
The Starch-Dye Bound Polymer, Amylase test system (product code CIW) is an in-vitro diagnostic device used in clinical chemistry to measure amylase activity in serum or urine using a substrate consisting of a dye-bound starch polymer; amylase cleaves the substrate, releasing colored fragments that are quantified photometrically. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1070 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CIW
- Device Class
- FDA class 2
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931559 | DMA AMYLASE PROCEDURE | Oct 28, 1993 | Substantially Equivalent | Data Medical Associates, Inc. |
| K924339 | OLYMPUS AMYLASE REAGENT | Oct 19, 1992 | Substantially Equivalent | Olympus Corp. |
| K884382 | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | Jan 11, 1989 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Mar 05, 1985 | Substantially Equivalent | Bio-Analytics Laboratories, Inc. |
| K812027 | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | Aug 03, 1981 | Substantially Equivalent | Eastman Kodak Company |
| K810584 | PHADEBAS ISOAMYLASE TEST | May 13, 1981 | Substantially Equivalent | Pharmacia, Inc. |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K782032 | UNITEST AMYLASE | Mar 02, 1979 | Substantially Equivalent | Boehringer Mannheim Corp. |
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.