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Accurun 130 Borrelia Burgdorferi Igg Positive Control

by Boston Biomedica, Inc.

510(k) K974809

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974809 Date5 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Accurun(Tm) 130 Borrelia Burgdorferi Igg Positive Control
510(k) Number
FDA Product Code
LSR
Device Class
Class II
Regulation
21 CFR Part 866.3830
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Accurun 130 Borrelia Burgdorferi Igg Positive Control is a reagent used in in vitro serology assays to detect IgG antibodies to Borrelia burgdorferi, the main cause of Lyme disease. It is designed to monitor test performance in these assays. The control is manufactured from human serum or plasma reactive for anti-Borrelia burgdorferi and nonreactive for certain other pathogens.

The Accurun 130 Borrelia Burgdorferi Igg Positive Control is supplied in a 1.0 mL volume and is used as an external control in serology testing. It is classified as a class 2 device and is regulated under the code 866.3830. The device has been cleared by the FDA under the traditional 510(k) clearance process, with the clearance number K974809.

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