Skip to content

IMUBIND Plasma PAI-1 ELISA, Model 822

by American Diagnostica, Inc.

510(k) K013168

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK013168 Date7 Mar 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1426-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010

    Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators

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  • Withdrawn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
GGP
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 IMUBIND Plasma PAI-1 ELISA, Model 822, is an enzyme-linked immunosorbent assay designed for the measurement of human Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in plasma. This device is classified as a qualitative and quantitative factor deficiency test.

This kit is intended for in vitro diagnostic use. It was authorized by the FDA under a Traditional 510(k) clearance (K013168) and reviewed by the Hematology advisory committee.

Other devices from American Diagnostica, Inc.

See all devices from American Diagnostica, Inc. →