# K981446: Wako Autokit LP (a)

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Mar 9, 1999 after 321 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: 2 (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) Apo-tek Lp (a) assay: named in the summary without a submission number
- (no number) Sigma’s LDL: named in the summary without a submission number

## Recalls of this device
- Jan 30, 2012 · Not classified · Z-1377-2012: In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
- Jul 6, 2006 · Not classified · Z-1409-06: Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.

## Indications for use
The Wako Lp(a) assay is an in vitro turbidimetric immunoassay for the quantitative-determination of lipoprotein(a) in serum or plasma to aid in the risk assessment of coronary heart disease (CAD).

Source page: https://510kreport.com/device/K981446
Methodology: https://510kreport.com/methodology