# K070199: Retic-Chex Linearity for BC

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Feb 23, 2007 after 32 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
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) Retic-Chex Linearity: named in the summary without a submission number

## Indications for use
Retic-Chex Linearity for BC is an assayed linearity kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.

Source page: https://510kreport.com/device/K070199
Methodology: https://510kreport.com/methodology