# K974306: Sangui Biotech, Inc. Intact-PTH (Parathyroid Hormone) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Sangui Biotech, Inc.
- Decided: Dec 23, 1997 after 36 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 1 (0 Class I)
- 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) Nichols Institute Diagnostics Allegro® Intact PTH (Parathyroid Hormone) kit: named in the summary without a submission number
- (no number) ACTIVE™ I-PTH ELISA kit: named in the summary without a submission number

## Recalls of this device
- Oct 26, 2016 · Class III · Z-1520-2018: There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

## Indications for use
The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site “sandwich” Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism.

Source page: https://510kreport.com/device/K974306
Methodology: https://510kreport.com/methodology