# K993669: Lipoprotein (a) SPQ Iii Antibody Reagent Set

- Pathway: 510(k) (Special)
- Applicant: DiaSorin, Inc.
- Decided: Nov 17, 1999 after 16 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- 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) SPQ™ II Antibody Reagent Set for Lipoprotein (a): named in the summary without a submission number

## Indications for use
FOR IN VITRO DIAGNOSTIC USE. The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations.

Source page: https://510kreport.com/device/K993669
Methodology: https://510kreport.com/methodology