510(k) · Cleared
ClearedQUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Cleared on Sep 6, 2017 as substantially equivalent to K000535 (Inova Diagnostics, Inc., 2000) after a 264-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Sep 6, 2017
- Review
- 264 days
- Class
- Class II
- Product code
- NBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000535 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000535 Quanta Lite LKM-1 ElisaInova Diagnostics, Inc. · 2000
- This deviceK163538 QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators…Inova Diagnostics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000535 | Quanta Lite LKM-1 Elisa | Inova Diagnostics, Inc. | 2000 | — |
| 0 (this device) | K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash®… | Inova Diagnostics, Inc. | 2017 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000535 | Quanta Lite LKM-1 ElisaSummary page 6…JJX Regulation Number 862.1660 Device Class 1 (reserved) Predicate device QUANTA Lite® LKM-1 ELISA, 510(k) number: k000535. Date declared: June 7, 2000. Device description The QUANTA Flash LKM-1 assay is designed to run on the BIO-FLASH® instrument.… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K000535.
How does its category compare?
All NBS devicesNBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NBS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NBS
Too few NBS 510(k)s in any year since 2007 to give a median.
Recalls per year · NBS
No recall names NBS since 2007.
Adverse event reports per year · NBS
No MAUDE report names NBS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163538: QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163538
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026