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Axis-Shield ACVTIVE-B12

by Axis-Shield Diagnostics, Ltd.

510(k) K121946

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121946 Date22 Mar 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CDD
Device class
Class II
Regulation
21 CFR Part 862.1810
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Axis-Shield ACVTIVE-B12 is a radioassay device for measuring Vitamin B12 levels in clinical chemistry. It is designed as an in vitro diagnostic test to quantitatively determine serum or plasma Vitamin B12 concentrations, aiding in the diagnosis of Vitamin B12 deficiency or megaloblastic anemia. The device operates as a chemiluminescent immunoassay, providing precise analytical results for laboratory use.

This device is supplied as a single-use, sterile reagent kit intended for professional use in clinical laboratories. It is classified under FDA product code CDD and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The ACVTIVE-B12 is intended for use in Class II regulatory settings, adhering to special controls for radioassay devices. Storage and handling follow standard in vitro diagnostic protocols to maintain sterility and performance integrity.

Devices cleared under K121946

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K121946
UDI-DISize and differences
Axis-Shield Active-B12 (Holotranscobalamin) EIA FMABT100
Axis-Shield Diagnostics Limited
FMABT100 / FMABT10005055845400046 —On the market

Similar devices

Other devices filed under FDA product code CDD (Radioassay, Vitamin B12).

Other devices from Axis-Shield Diagnostics Limited

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