510(k) · Cleared
ClearedAccess anti-HAV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Sep 9, 2025 as substantially equivalent to K190428 (Roche Diagnostics, 2019) after a 267-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Sep 9, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P780012 (1979). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LOL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOL device
- #1 K251995 Access anti-HAV IgMscore 13.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K190428 | Elecsys Anti-HAV IISummary page 5…erological assays Classification Regulation: 21 CFR 866.3310 Class: 2 Classification Product Code: LOL Predicate Device Device Name: Elecsys Anti-HAV II 510(k) Numbers: K190428 Purpose for Submission: New device market clearance of Access anti-HAV assay for use on the DxI 9000 Immunoassay Analyzer Devic… | 2019 |
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?
- The line of descent spans 46 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K190428.
How does its category compare?
All LOL devicesLOL Hepatitis A Test (Antibody And Igm Antibody): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LOL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOL
108in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOL
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOL
19in 2025
MAUDE reports naming product code LOL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 2 | 2 |
| 2008 | 3 | 108 | 1 | 13 |
| 2009 | 2 | — | 1 | 24 |
| 2010 | 2 | — | 0 | 53 |
| 2011 | 1 | — | 1 | 353 |
| 2012 | 1 | — | 0 | 42 |
| 2013 | 0 | — | 0 | 49 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 2 | — | 0 | 36 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 1 | 61 |
| 2019 | 1 | — | 2 | 51 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 1 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 19 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the Dxl 9000 Access Immunoassay…
Read the full statement (157 words)
The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative
detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years)
and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate,
acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the Dxl 9000 Access Immunoassay Analyzer.
The Access anti-HAV assay is indicated as an aid in the diagnosis of current or past HAV infection in persons with risk
factors and/or signs or symptoms of hepatitis A, when used in conjunction with other serological and clinical information.
The assay may also be used in the identification of HAV susceptible individuals and to determine the presence of an
antibody response to HAV in vaccine recipients.
This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or
tissue-based products (HCT/Ps).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243846: Access anti-HAV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243846
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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