# K973100: Prostate Specific Antigen (Psa) Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Sep 29, 1997 after 41 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) aca® plus Prostate Specific Antigen Calibrator: named in the summary without a submission number

## Most influential descendants
- K020980: Dimension Tpsa Calibrator, Model #RC459 (2002), 0 descendants of its own

## Indications for use
The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

Source page: https://510kreport.com/device/K973100
Methodology: https://510kreport.com/methodology