# K063398: Esa Leadcare II Lead Control

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Dec 5, 2006 after 26 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830234 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830234: Contox Heavymetals Control, Kaulson Laboratories, Inc. (1983) Summary page 1.

## Indications for use
ESA Biosciences LeadCare II Control is intended to be used to monitor and evaluate the analytical performance of the ESA Biosciences LeadCare II Analyzer for the measurement of lead in blood. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of lead provided by the controls allow performance monitoring within the clinically important range.

Source page: https://510kreport.com/device/K063398
Methodology: https://510kreport.com/methodology