# K032122: Audit Microcontrols Microfd BNP Control

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Sep 9, 2003 after 62 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions. It is intended to simulate human patient plasma samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays.

Source page: https://510kreport.com/device/K032122
Methodology: https://510kreport.com/methodology