# K180975: QUANTA Flash HMGCR Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 25, 2018 after 73 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: 4 generations back to K000312 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols, Inova Diagnostics, Inc. (2016) Summary page 6.

## Indications for use
QUANTA Flash HMGCR is a chemiluminescent immunoassay for the semi-quantitative determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigen in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy (IIM).

Source page: https://510kreport.com/device/K180975
Methodology: https://510kreport.com/methodology