# K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Feb 12, 2016 after 260 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000312 (2000). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053653: Fidis Connective 10, Model MX006, Biomedical Diagnostics (Bmd) SA (2006) Summary page 6.

## Most influential descendants
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own
- K180975: QUANTA Flash HMGCR Reagents (2018), 0 descendants of its own

## Indications for use
QUANTA Flash Jo-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum. The presence of anti-Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy. QUANTA Flash Jo-1 Calibrators are intended for use with the QUANTA Flash Jo-1 Reagents for the determination of IgG anti-Jo-1 antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash Jo-1 Controls are intended for use with the QUANTA Flash Jo-1 Reagents for quality control in the determination of IgG anti-Jo-1 antibodies in human serum.

Source page: https://510kreport.com/device/K151429
Methodology: https://510kreport.com/methodology