# K994277: Access Ostase QC

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 14, 2000 after 25 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891475 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981864: Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219, Beckman Coulter, Inc. (1998) Summary page 1.

## Recalls of this device
- Nov 10, 2011 · Not classified · Z-1239-2012: The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control 
- May 10, 2011 · Not classified · Z-2606-2011: The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in

## Indications for use
Beckman Coulter’s Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

Source page: https://510kreport.com/device/K994277
Methodology: https://510kreport.com/methodology