FDA product code CIW: Starch-Dye Bound Polymer, Amylase
CIW is the FDA product code for starch-dye bound polymer, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under CIW, from 8 different applicants. The average 510(k) review took 69 days (median 61). FDA has posted 5 recalls for CIW devices.
Classification
| Field | Value |
|---|---|
| Device name | Starch-Dye Bound Polymer, Amylase |
| Device class | Class II |
| Regulation | 21 CFR 862.1070 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CIW clearance
Top CIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Data Medical Associates, Inc. | 1 | 1993-10-28 |
| Olympus Corp. | 1 | 1992-10-19 |
| Em Diagnostic Systems, Inc. | 1 | 1989-01-11 |
| Bio-Analytics Laboratories, Inc. | 1 | 1985-03-05 |
| Eastman Kodak Company | 1 | 1981-08-03 |
3 more applicants have CIW clearances. See the full list in Caduvo.
Most recent CIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931559 | Data Medical Associates, Inc. | DMA AMYLASE PROCEDURE | 1993-10-28 | 212 |
| K924339 | Olympus Corp. | OLYMPUS AMYLASE REAGENT | 1992-10-19 | 52 |
| K884382 | Em Diagnostic Systems, Inc. | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | 1989-01-11 | 85 |
| K850639 | Bio-Analytics Laboratories, Inc. | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | 1985-03-05 | 14 |
| K812027 | Eastman Kodak Company | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | 1981-08-03 | 14 |
Recalls for CIW devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-05-11.
| Year | Recalls |
|---|---|
| 2020 | 4 |
Frequently asked questions
What is FDA product code CIW?
CIW is the FDA product code for starch-dye bound polymer, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is CIW?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIW?
Across 8 cleared submissions the average was 69 days from receipt to decision (median 61).
Which companies have the most CIW clearances?
Data Medical Associates, Inc. (1); Olympus Corp. (1); Em Diagnostic Systems, Inc. (1); Bio-Analytics Laboratories, Inc. (1); Eastman Kodak Company (1).
Have CIW devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2020-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code CIW
- Run a recall and safety report across every CIW manufacturer
- Watch product code CIW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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