# K163538: QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Sep 6, 2017 after 264 days
- Product code: NBS (Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000535 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000535: Quanta Lite LKM-1 Elisa, Inova Diagnostics, Inc. (2000) Summary page 6.

## Indications for use
QUANTA Flash LKM-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-liver/kidney microsome type 1 antibodies in human serum. The presence of anti-liver/kidney microsome type 1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of autoimmune hepatitis type 2. QUANTA Flash LKM-1 Calibrators are intended for use with the QUANTA Flash LKM-1 Reagents for the determination of IgG anti-LKM-1 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash LKM-1 Controls are intended for use with the QUANTA Flash LKM-1 Reagents for quality control in the determination of IgG anti-LKM-1 autoantibodies in human serum.

Source page: https://510kreport.com/device/K163538
Methodology: https://510kreport.com/methodology