# K981634: Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuits Corp.
- Decided: Oct 13, 1998 after 158 days
- Product code: LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Hybritech Tandem-E® PSA ImmunoEnzyMetric Assay: named in the summary without a submission number

## Indications for use
The I0S Prostate Specific Antigen Test Cartridges are intended to be used for the quantitative determination of prostate specific antigen in human serum as an aid in the management of patients diagnosed with prostate cancer. They are intended to be used with the Biocircuits. IOS® instrument in clinical laboratories, physician. office laboratories, and other alternate sites of use close to the point of patient care. The I0S PSA Controls are to be used to assist in monitoring accuracy and precision in the IOS PSA Test Cartridges.

Source page: https://510kreport.com/device/K981634
Methodology: https://510kreport.com/methodology