510(k) · Cleared

Recalled · Class III · 2021

Vitros Immunodiagnostic Products Anti-HBC Igm Controls

K032993510(k) TraditionalCleared Oct 31, 200336-day reviewClass I21 CFR 862.1660Recalls 1

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. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Oct 31, 2003 as substantially equivalent to K974613 (Blackhawk Biosystems, Inc., 1998) after a 36-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.

Decided: Oct 31, 2003
Review: 36 days
Class: Class I
Product code: JJX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K974613 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK974613 Virotrol IiiBlackhawk Biosystems, Inc. · 1998
This deviceK032993 Vitros Immunodiagnostic Products Anti-HBC Igm ControlsOrtho-Clinical Diagnostics, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974613	Virotrol Iii	Blackhawk Biosystems, Inc.	1998	—
0 (this device)	K032993	Vitros Immunodiagnostic Products Anti-HBC Igm Controls	Ortho-Clinical Diagnostics, Inc.	2003	—

FIG. 1 — Lineage of K032993, 1998–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJX? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K974613	Virotrol Iii Summary page 1 …s Immunodiagnostic Products Anti-HBc IgM Controls are substantially equivalent to Blackhawk BioSystems, Inc Virotrol 111 (K9746 13). Ortho-Clinical Diagnostics, Inc. VITROS Anti-HBc IgM Controls Page 4 of 27 V…	Blackhawk Biosystems, Inc.	1998	—

Also cleared against K974613: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 15, 2021	Class III	Z-0247-2022	Under Investigation by firm	Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K974613.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of IgM antibody to Hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (heparin, EDTA or citrate).

For in vitro diagnostic use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032993 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032993: Vitros Immunodiagnostic Products Anti-HBC Igm Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032993

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