# K982708: SPQ Test System

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Apr 2, 1999 after 241 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Strategic Diagnostics Macra Lp (a): named in the summary without a submission number

## Most influential descendants
- K013359: LP (a)-Latex Seiken Assay Kit (2002), 4 descendants of its own
- K082488: Diazyme LP (a) Assay (2009), 3 descendants of its own
- K122722: Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2 Califrator Set Model 05852641160 (2012), 1 descendant of its own
- K241220: Tina-quant Lipoprotein (a) Gen.2 Molarity (2025), 0 descendants of its own
- K131556: Diazyme Lipoprotein (a) Calibrator Set, Control Set (2013), 0 descendants of its own

## Recalls of this device
- Jan 10, 2005 · Not classified · Z-0636-05: QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp

## Indications for use
The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(@) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurment 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/K982708
Methodology: https://510kreport.com/methodology