← Back to catalogue

AST/GOT (IFCC), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K071580Ref 981839

by Thermofisher Scientific OY

Identity

Trade Name
Pyridoxal Phosphate EUDAMED
Device Name
Pyridoxal Phosphate EUDAMED
Model / Reference
981839 EUDAMED

Identifiers

Primary DI / UDI-DI
16438153818394 EUDAMED
Basic UDI-DI
6438153BU00164BY EUDAMED
B-16438153818394 EUDAMED
Direct Marketing DI
16438153818394 EUDAMED
510(k) Number
K071580 FDA 510(k)
FDA Product Code
CIT FDA 510(k)
EMDN Code
W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
W0102070203 VITAMIN B6 EUDAMED

Classification

Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1100 FDA 510(k)
Regulation Number
862.1100 FDA 510(k)
Market of Registration
Finland EUDAMED
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

This device is a Nadh Oxidation/Nad Reduction, Ast/Sgot reagent set, designed for in vitro diagnostic use in clinical chemistry. It measures aspartate aminotransferase (AST) and glutamate oxaloacetate transaminase (GOT) activity using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method, alongside pyridoxal phosphate, a cofactor in transaminase reactions. The reagents are formulated for photometric analysis in automated clinical chemistry analyzers, enabling precise biochemical assessments of liver function and metabolic health.

The AST/GOT (IFCC) reagent set is supplied as a multi-component kit for laboratory use, including Ecal, Nortrol, and Abtrol controls for quality assurance. It is intended for single-use in sterile, pre-packaged formats, adhering to FDA 510K, IVDD, and IVDR regulatory standards. Compatibility with MRI environments is not specified, and storage requires adherence to manufacturer guidelines for temperature and humidity to maintain reagent stability. Authorized under K071580 and classified as a Class II device, it is distributed exclusively for professional medical laboratory use.

Frequently asked questions

What clinical applications does this AST/GOT reagent set support in laboratory testing?

This AST/GOT (IFCC) reagent set is designed for measuring aspartate aminotransferase (AST) and glutamate oxaloacetate transaminase (GOT) activity using the IFCC reference method. It is primarily used in clinical chemistry for assessing liver function and metabolic health by enabling precise photometric analysis in automated analyzers. The included pyridoxal phosphate ensures accurate transaminase reaction measurements.

How is this reagent set supplied, and is it intended for single-use or reuse?

The AST/GOT (IFCC) reagent set is supplied as a multi-component kit in sterile, pre-packaged formats, including Ecal, Nortrol, and Abtrol controls for quality assurance. It is explicitly intended for single-use only, adhering to standard laboratory safety and sterility protocols.

What regulatory pathways does this device follow, and what class designation does it hold?

This device follows FDA 510(k) clearance, IVDD (In Vitro Diagnostic Directive), and IVDR (In Vitro Diagnostic Regulation) pathways. It is classified as a Class II medical device under the FDA’s regulatory framework, with the K-number K071580, and is authorized for professional medical laboratory use.

Are there any special storage requirements for maintaining the stability of these reagents?

While the data does not specify exact storage conditions, the manufacturer’s guidelines must be followed to ensure stability. Typically, reagents like these require controlled temperature and humidity to prevent degradation. Always refer to the provided documentation for precise storage instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

European Union Active

IVDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Thermofisher Scientific OY

Sources (3)

  • FDA 510(k) K071580 24 fields · synced Oct 6, 2026
  • EUDAMED 2d36f4fe-c9f8-4870-8ba0-609dca4c1dac 61 fields · synced Jun 20, 2026
  • EUDAMED dd2eb670-cf1e-474f-b8c6-b8d3ac63e1e5 61 fields · synced Jul 25, 2026