510(k) · Cleared
ClearedVitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Sep 14, 2006 as substantially equivalent to P780012 (Abbott Laboratories, 1979) and 1 other predicate after a 184-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Sep 14, 2006
- Review
- 184 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P780012 (1979). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backP780012 HAVABAbbott Laboratories · 1979 · Recalled
- This deviceK060678 Vitros Immunodiagnostic Products Anti-Hav Total Reagent…Ortho-Clinical Diagnostics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK142758 ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142758ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P780012 | HAVAB | Abbott Laboratories | 1979 | 1 |
| 0 (this device) | K060678 | Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| +1 | K142758 | ADVIA Centaur HAV total assay | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 13.8 · 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? (2)
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 |
|---|---|---|---|
| * | P780012 | HAVABSummary page 1…ls Class: I 4 Predicate Device The VITROS Immunodiagnostic Products Anti-HAV Total assay is substantially equivalent to the IMX HAVAB 2.0 assay (PMA P780012). The VITROS Immunodiagnostic Products Anti-HAy Total Controls is substantially equivalent to Blackhawk BioSystern… | 1979 |
| * | K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak SystemsSummary page 1…PMA P780012). The VITROS Immunodiagnostic Products Anti-HAy Total Controls is substantially equivalent to Blackhawk BioSysterns, Inc. Virotrol II (BK960085). 5 Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quant… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142758 | ADVIA Centaur HAV total assay | 2014 | 0 |
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?
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.
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?
VITROS Anti-HAV Total Reagent Pack: For the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis A virus (anti-HAV) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. The assay is indicated, in conjunction with other serological and clinical information, as an aid in the clinical laboratory diagnosis of individuals with acute or past hepatitis A virus…
Read the full statement (166 words)
VITROS Anti-HAV Total Reagent Pack:
For the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis A virus (anti-HAV) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System.
The assay is indicated, in conjunction with other serological and clinical information, as an aid in the clinical laboratory diagnosis of individuals with acute or past hepatitis A virus infection, or as an aid in the identification of HAV-susceptible individuals prior to HAV vaccination. The detection of HAV-specific antibodies in human serum or plasma is laboratory evidence of acute or recent HAV infection.
VITROS Anti-HAV Total Calibrator
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative detection of antibodies to hepatitis A virus (anti-HAV) in human serum and plasma (EDTA, heparin or citrate).
VITROS Anti-HAV Total Controls
For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of Htepatitis A virus (anti-HAV).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060678: Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060678
Report an extraction error
Are you the manufacturer?
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