# K954723: Enzyme Immunoassay Ana Screening Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helix Diagnostics, Inc.
- Decided: Dec 15, 1995 after 63 days
- Product code: LKJ (Antinuclear Antibody, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 11 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200 (2004), 1 descendant of its own
- K984476: Liquichek Anti-RNP Control, Eia, Model 207 (1998), 1 descendant of its own
- K984479: Liquichek Anti-SM Control, Eia, Model 208 (1998), 1 descendant of its own
- K984470: Liquichek Anti-SS-a Control, Eia, Model 209 (1998), 1 descendant of its own
- K984475: Liquichek Anti-SCL-70 Control, Eia, Model 212 (1998), 1 descendant of its own

## Recalls of this device
- Jun 24, 2010 · Not classified · Z-0612-2011: Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not p
- Mar 1, 2010 · Not classified · Z-0539-2011: The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
- Mar 1, 2010 · Not classified · Z-0540-2011: The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
- Mar 1, 2010 · Not classified · Z-1478-2011: Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
- Mar 1, 2010 · Not classified · Z-1479-2011: The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
- Feb 24, 2010 · Not classified · Z-0613-2011: False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. Fa

Source page: https://510kreport.com/device/K954723
Methodology: https://510kreport.com/methodology