# K121237: Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls LE

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: May 18, 2012 after 24 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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: 1 generation back to K022232 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022232: Cliniqa Liquid-QC HCG Control Level 1, 2, and 3, Cliniqa Corporation (2002) Summary page 1.

## Most influential descendants
- K133002: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (2015), 0 descendants of its own

## Indications for use
Cliniqa Beta HCG Controls, Levels 1, 2, and 3 and Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.

Source page: https://510kreport.com/device/K121237
Methodology: https://510kreport.com/methodology