510(k) · Cleared

Cleared

Vitros Immunodiagnostic Products Afp Range Verifiers

K990061510(k) TraditionalCleared Jan 25, 199917-day reviewClass I21 CFR 862.1660

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 Jan 25, 1999 as substantially equivalent to K973517 (Johnson & Johnson Clinical Diagnostics, Inc., 1997) after a 17-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jan 25, 1999
Review: 17 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K973517 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
This deviceK990061 Vitros Immunodiagnostic Products Afp Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973517	Vitros Immunodiagnostic Products Range Verifiers	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
0 (this device)	K990061	Vitros Immunodiagnostic Products Afp Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1999	—

FIG. 1 — Lineage of K990061, 1997–1999Source: 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
*	K973517	Vitros Immunodiagnostic Products Range Verifiers Summary page 1 …AFP). 3. Predicate Device The VITROS Immunodiagnostic Products AFP Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products FSH Range Verifiers (K973517). 4. Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantit…	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
†	K962919	Vitros Immunodiagnostic System	Johnson & Johnson Clinical Diagnostics, Inc.	1996	5
†	K964310	Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total…	Johnson & Johnson Clinical Diagnostics, Inc.	1996	3

Also cleared against K973517: 7 other devices →

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.
7 other devices also cite its predicate K973517.

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?

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990061 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990061: Vitros Immunodiagnostic Products Afp Range Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990061

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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