# K061282: Access Ultrasensitive HGH Calibrator, Model 33585

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 2, 2006 after 25 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 K003098 (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)
- K003098: Access Ultrasensitive HGH Calibrators, Beckman Coulter, Inc. (2000). Our reading of the summary gave K003089, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Access Ultrasensitive hGH Calibrators”.

## Indications for use
The Access Ultrasensitive hGH Calibrators are intended to calibrate the Access Ultrasensitive hGH Assay for the quantitative determination of hGH levels in human serum and plasma on the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K061282
Methodology: https://510kreport.com/methodology