# K042336: Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Oct 14, 2004 after 45 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K904461 (1990). 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)
- K904461: Meter Trax, Hematronix, Inc. (1990) Summary page 2.

## Indications for use
Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory testing procedures for the analytes listed in this package insert. The following parameters are listed in the package insert: * Glucose * Hemoglobin * Hematoait

Source page: https://510kreport.com/device/K042336
Methodology: https://510kreport.com/methodology