# K083744: Binaxnow Malaria Positive Control Kit, Model 665-010

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Sep 1, 2009 after 259 days
- Product code: MJZ (Kit, Direct Antigen, Positive Control)
- 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. The FDA summary names its predicate without a number.
- (no number) Bio-Rad Laboratories (Blackhawk BioSystems, Inc.) CryptoTrol: named in the summary without a submission number

## Indications for use
The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malaria Test. It is designed for routine use to aid in verifying proper performance of the procedure and the antigen detection reagents of the BinaxNOW® Malaria Test.

Source page: https://510kreport.com/device/K083744
Methodology: https://510kreport.com/methodology