# K981930: Unicap Thyroid Peroxidase Igg

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Jul 7, 1998 after 67 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- 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) Varelisa Thyroglobulin Antibodies Assay: named in the summary without a submission number
- (no number) Varelisa Thyroid Peroxidase Antibodies Assay: named in the summary without a submission number

## Most influential descendants
- K072661: Immunocap Thyrlobulin Immunocap (2007), 0 descendants of its own

## Indications for use
UniCAP Thyroid Peroxidase ImmunoCAP™ is a device for the in vitro quantitative measurement of igG antibodies specific for Thyroid Peroxidase (TPQ) in human serum and plasma. UniCAP Thyroid Peroxidase ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories. UniCAP Specific 1gG is an in vitro test system for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen immunoCAP solid phase component of the UniCAP Specific IgG System. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

Source page: https://510kreport.com/device/K981930
Methodology: https://510kreport.com/methodology