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A/C Enzymatic Vitamin B6 Assay

by Anticancer, Inc.

510(k) K111260

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111260 Date26 Jul 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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

Overview

AI-generated summary, 19 Sep 2026

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

The A/C Enzymatic Vitamin B6 Assay is a radioassay device intended for the quantitative determination of pyridoxal 5′-phosphate (PLP, vitamin B6) in EDTA-plasma. It is based on PLP-dependent recombinant homocysteine-α,γ-lyase (rHCYase), which is prepared in the apo-enzyme form by stripping off the cofactor PLP. The restoration of enzymatic activity by reconstitution of the holoenzyme depends on the amount of PLP in the plasma bound to apo-enzyme and produces hydrogen sulfide.

The device received FDA 510(k) clearance (K111260) on July 26, 2012, and is classified as a Class II device under regulation number 862.1810. It is supplied by Anticancer, Inc., located in San Diego, CA, and is used in clinical chemistry settings for vitamin B6 measurement.

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