# P Amy AY3855

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/p-amy-ay3855>
- Manufacturer: [Randox Laboratories, Ltd.](https://devicerts.com/manufacturers/randox-laboratories-ltd)
- Name in the registry: P AMY AY3855
- Device class: IVD General (EU IVDD); Class II (US FDA)
- FDA product code: JFJ
- EMDN: W01010108 AMYLASE ISOENZYMES
- GMDN: Alpha-amylase isoenzyme IVD, reagent (52943)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-05055273200614 · UDI-DI 05055273200614 · registered 2026-10-27 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 05055273200614 · listed 2016-09-09 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K971825 · decision 1997-07-24 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2924-2020 · Class II · terminated · initiated 2020-07-10: Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

## Identity

- Trade name: PANCREATIC α‑AMYLASE (P AMY) [EUDAMED]; P AMY [FDA GUDID (AccessGUDID)]
- Generic name: Alpha-amylase isoenzyme IVD, reagent [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: AY3855 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05055273200614 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-05055273200614 [EUDAMED]
- 510(k) Number: K971825 [FDA GUDID (AccessGUDID)]
- FDA product code: JFJ [FDA GUDID (AccessGUDID)]
- EMDN code: W01010108 [EUDAMED]
- GMDN term: Alpha-amylase isoenzyme IVD, reagent (52943) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1070 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Northern Ireland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Reagent: Yes [EUDAMED]
- IVD kit: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: P Amy AY3855, Randox Laboratories, Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/p-amy-ay3855 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/p-amy-ay3855.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/p-amy-ay3855
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.