# K960557: Calibration Verification Assessment (Cva)

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Apr 3, 1996 after 54 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 K942822 (1994). 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)
- K942822: CBC-Line Hematology Linearity Control, R&D Systems, Inc. (1994) Summary page 1.

## Indications for use
CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/lhemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.

Source page: https://510kreport.com/device/K960557
Methodology: https://510kreport.com/methodology