# K973514: Active Intact PTH

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Oct 31, 1997 after 44 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- 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) DSL 8000 Active™ I-PTH Irma: named in the summary without a submission number

## Indications for use
The DSL ACTIVE™ I-PTH Coated Bead IRMA assay is intended for the quantitative determination of I-PTH in human serum. This assay is intended for in vitro diagnostic use. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Source page: https://510kreport.com/device/K973514
Methodology: https://510kreport.com/methodology