# K153712: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Jan 28, 2016 after 35 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
Longest line of descent: 3 generations back to K863751 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091225: Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set, Maine Standards Co. (2009) Summary page 8.

## Indications for use
For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-RS, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.

Source page: https://510kreport.com/device/K153712
Methodology: https://510kreport.com/methodology