# K133676: Abx Pentra Micro Alb Control L/H

- Pathway: 510(k) (Abbreviated)
- Applicant: Horiba Abx Sas
- Decided: Jul 11, 2014 after 224 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 K971954 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072835: Liquichek Microalbumin Control Level 1, Level 2, Control Minipak, Bio-Rad, Diagnostics Grp. (2007) Summary page 1.

## Indications for use
ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.

Source page: https://510kreport.com/device/K133676
Methodology: https://510kreport.com/methodology