# K070144: Inhibin a Calibrators & Controls on the Access Immunoassay Systems

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 1, 2007 after 16 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K002128 (2000). 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)
- K002128: Active Inhibin-a Elisa, Model DSL-10-28100, Diagnostic Systems Laboratories, Inc. (2000) Summary page 1.

## Indications for use
The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems. The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.

Source page: https://510kreport.com/device/K070144
Methodology: https://510kreport.com/methodology