# K112603: Access Hybritech P2PSA QC on the Access Immunoassay Systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 4, 2011 after 58 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 K993210 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993210: Access Hybritech Free Psa QC, Model 37219, Beckman Coulter, Inc. (2000) Summary page 1.

## Most influential descendants
- K131536: Immulite 2000 Psa Calibration Verification Material (2013), 1 descendant of its own
- K122534: Immulite 1000 Third Generation Psa Calibration Verification Material (2013), 1 descendant of its own
- K133816: Immulite 2000 Free Psa Calibration Verification Material (2014), 0 descendants of its own
- K132739: Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material (2014), 0 descendants of its own

## Indications for use
The Access Hybritech p2PSA QC are tni-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K112603
Methodology: https://510kreport.com/methodology