510(k) Report

510(k) · Cleared

Cleared

Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and Controls

K060770510(k) TraditionalCleared Sep 15, 2006177-day reviewClass II21 CFR 866.3310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ortho-Clinical Diagnostics, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)

Cleared on Sep 15, 2006 as substantially equivalent to P790019 (Abbott Laboratories, 1980) and 1 other predicate after a 177-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.

Decided
Sep 15, 2006
Review
177 days
Class
Class II
Product code
LOL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to P790019 (1980). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2016: 1 descendant clearedP790019 · Havab-M Diagnostic Kit · Abbott Laboratories · 1980 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant P790019 · Havab-M Diagnostic Kit · Abbott Laboratories · 1980 · recalled0
  1. Root · 1 generation backP790019 Havab-M Diagnostic KitAbbott Laboratories · 1980 · Recalled
  2. This deviceK060770 Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2006
  3. Descendant · cites it directly · 0 of its ownK161964 ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P790019Havab-M Diagnostic KitAbbott Laboratories19801
0 (this device)K060770Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and…Ortho-Clinical Diagnostics, Inc.2006—
+1K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K060770, 1980–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251995 Access anti-HAV IgMscore 13.8 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*P790019Havab-M Diagnostic Kit
Summary page 2
…Predicate Device The VITROS Immunodiagnostic Products Anti-HAV IgM assay is substantially equivalent to the IMX HAVAB-M assay (PMA P790019). The VITROS Immunodiagnostic Products Anti-HAV IgM Controls is substantially equivalent t…
Abbott Laboratories19801
*K974613Virotrol Iii
Summary page 2
…The VITROS Immunodiagnostic Products Anti-HAV IgM Controls is substantially equivalent to Blackhawk BioSystems, Inc Virotrol III (K974613). 5 Device Description The VITROS Immunodiagnostic System uses luminescence as the signal…
Blackhawk Biosystems, Inc.1998—

Also cleared against P790019: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.20160

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K161964 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate P790019.

How does its category compare?

All LOL devices

LOL 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

2007: 32008: 32009: 22010: 22011: 12012: 12014: 22016: 22019: 12020: 12021: 12022: 12023: 12025: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOL

108in 2008

2007: 182 days median2008: 108 days median
2007high 182 (2007) · low 108 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LOL

2in 2019

2007: 22008: 12009: 12011: 12018: 12019: 2
2007high 2 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOL

19in 2025

2007: 22008: 132009: 242010: 532011: 3532012: 422013: 492014: 192015: 292016: 362017: 262018: 612019: 512020: 1042021: 122022: 172023: 362024: 212025: 19
2007high 353 (2011) · low 2 (2007)2025

MAUDE reports naming product code LOL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318222
20083108113
20092—124
20102—053
20111—1353
20121—042
20130—049
20142—019
20150—029
20162—036
20170—026
20180—161
20191—251
20201—0104
20211—012
20221—017
20231—036
20240—021
20251—019
20262—0—

What is it indicated for?

For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. The assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results in conjunction with other clinical information, may be used for the laboratory diagnosis of individuals…

Read the full statement (129 words)

For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System.

The assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results in conjunction with other clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A.

For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative determination of IgM antibody to hepatitis A viral antigen (HAV) in human serum and plasma (EDTA, heparin or citrate.

For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of anti-HAV IgM.

Indications for use as stated in the FDA summary.

Also cleared against P790019

1 other device cites the same predicate.

  • K093955Anti-Hav IgmRoche Diagnostics · 20102 recalls

More from Ortho-Clinical Diagnostics, Inc.

273 FDA decisions under this applicant name. See the company

  • K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
  • DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • P090028/S018VITROS Immunodiagnostic Products HBeAg Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc. · 2023
  • P030026/S037VITROS Anti-HBc IgMOrtho-Clinical Diagnostics, Inc. · 2023

Recent decisions in LOL

The LOL category page

  • K260048Elecsys Anti-HAV IgMRoche Diagnostics · 2026
  • K251995Access anti-HAV IgMBeckman Coulter, Inc. · 2026
  • K243846Access anti-HAVBeckman Coulter, Inc. · 2025
  • K222850HAVAb IgG IIAbbott Laboratories · 2023
  • K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc. · 2022

https://510kreport.com/device/K060770 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060770: Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060770

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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